SASKIA V. POPESCU, PHD, MPH, MA, CIC, is a hospital epidemiologist and infection preventionist. During her work as an infection preventionist, she performed surveillance for infectious diseases, preparedness, and Ebola-response practices. She holds a doctorate in biodefense from George Mason University where her research focused on the role of infection prevention in facilitating global health security efforts. She is certified in infection control and has worked in both pediatric and adult acute care facilities.

Saskia v. Popescu, PhD, MPH, MA, CIC, discusses this weeks Hot Topics in Infection Prevention.

? Not particularly surprising…this is our third winter with COVID-19, so perhaps we’ll know what to do…better, this time?

Health Care Associated-Infections (HAIs)– Up in 2021

This isn’t surprising either, and for many individuals, this was expected based off personal experience, but it was nice to see the official 

data shared by the Centers for Disease Control and Prevention (CDC

). Between the first year of the COVID-19 pandemic (2020) and last year (2021), the CDC reports through an annual highly that there was a 7% increase in central line-associated bloodstream infections (CLABSIs), a 5% increase in catheter-associated urinary tract infections (CAUTIs); both types of infections were notably in intensive care units (ICUs), but also a 12% increase in VAE with the biggest jump of 16% in non-ICUs.

Thankfully, there was not a significant change to surgical site infections (SSIs), but those were only in the 10 procedures tracked. The CDC did note an 11% increase in abdominal hysterectomy SSIs. Interesting, there was a 14% increase in hospital onset MRSA bacteremia and a 3% decrease in hospital onset 

.What’s interesting is that if we look at the 

 (comparing 2019 to 2020), there was a 24% increase in CLABSIs, no significant change in CAUTIs, but a 35% increase in ventilator-associated events (VAEs).

What is even more interesting was the 15% increase in hospital onset methicillin-resistant 

 (MRSA) bacteremia and the 11% decrease in hospital onset 

. I mention this because it points to improvement in how we are managing HAIs in the face of the pandemic. The capacity to address a serious rise in HAIs in the second year of a pandemic, while rolling out vaccinations and managing novel variants, is a feat that has gotten little recognition. One piece, though, I find interesting is the from an 11% decrease in 

 cases to 3% in this most recent report. It begs the question if we’ve overcorrected so much with discussions around cleaning and disinfection related to COVID-19 in the first year of the pandemic, that it’s rippled into our general behaviors and practices.

presenting COVID-19 incidence among staff and students across schools in relation to universal masking. Keeping it short and sweet: When masking requirements were lifted, there was an associated increase in cases. According to the authors, “Before the statewide masking policy was rescinded, trends in the incidence of Covid-19 were similar across school districts. During the 15 weeks after the statewide masking policy was rescinded, the lifting of masking requirements was associated with an additional 44.9 cases per 1000 students and staff (95% confidence interval, 32.6 to 57.1), which corresponded to an estimated 11,901 cases and to 29.4% of the cases in all districts during that time.”

The Ebola outbreak in Uganda has officially 

 (eastern Uganda) and outside of the central region it had been mostly impacting, bringing the total cases to 135 confirmed and 53 deaths. 

Arizona has just reported a case of locally-acquired Dengue

, which is worrisome for the state in which the virus does not traditionally exist. Mosquito trap surveillance confirmed the presence of the virus through a positive sample as well.

Articles

Saskia v. Popescu, PhD, MPH, MA, CIC, covers updates on health care associated-infections, masking at schools, and Ebola in Uganda and Dengue in Arizona. Read on for all the details. 


Hot Topics in IPC: Health Care Associated-Infections, COVID-19, Ebola, Dengue 

Tori Whitacre Martonicz is the editor of 

.  She has been a writer and editor for over 30 years, and she has an MA and BA in English Composition/Literature from the University of Akron in Akron, OH. She lives in Ohio with her husband; son; 2 tiny dogs, Selena Brigid Sophia and Doctor Danger Dog; and a big black cat, Freya. She loves reading, writing, gardening, and spending time with her loved ones.

William Delaney, PhD, chief scientific officer of Assembly Bio, answered 

's questions about their research on their posters presented at AASLD The Liver Meeting. 

affect over 300 million people worldwide in 2019, and World Health Organization estimates that 1.1 million individuals died during that same year from the effects of those 2 viruses, including cirrhosis, liver cancer, and other conditions that stem from chronic viral hepatitis. While all forms A, B, C, D, and E, of hepatitis can be controlled or prevented, no long-term cure for hepatitis B has been developed. Recently at the 2022 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, Assembly Bio, a company focused on finding a cure for highly potent hepatitis B (HBV). 

) asked William Delaney, PhD, chief scientific officer of Assembly Bio, about the posters that Assembly Bio presented at AASLD The Liver Meeting.

: A summary of the key information of these posters and why they are important.

The data Assembly Bio presented at AASLD in 2022 highlights the company’s progress in both advancing and broadening our early-stage virology programs. We presented preclinical data on or our next-generation, HBV core inhibitor candidate, ABI-4334 (4334), that demonstrate its nanomolar potency to disrupt the HBV replication cycle at multiple points (importantly at the point of cccDNA [viral reservoir] formation, which our first-generation core inhibitors haven’t been able to inhibit) and support its entry into clinical studies. The Phase 1a study evaluating the activity and safety of 4334 initiated in Q4.

We also presented the first data for 2 of our recently announced programs. This includes data highlighting the preclinical characterization of our small molecule potent, orally bioavailable viral entry inhibitors for HBV and hepatitis D virus (HDV). And, finally, we shared the first preclinical data on a novel series of orally bioavailable small molecule interferon-a receptor (IFNAR) agonists designed to inhibit HBV and engage the immune system with potential to offer efficacy, but also critically, improved tolerability (the major limitation of current biologic interferons) in HBV, as well as for other viruses such as HDV. The data from each are summarized in our 

: What is the practical application for the key findings for infection preventionists from this study?

 Assembly Bio’s next generation core inhibitors, including 4334, and our IFNAR agonist program support a key aspect of our mission: to develop finite treatments and functional cures for hepatitis B. While vaccines for hepatitis B exist, there are an estimated almost 300 million patients living with hepatitis B worldwide, with up to a million people dying each year of HBV-related causes. There are treatments available, but they are lifelong and reduce–but do not eliminate–the virus, so cure rates are very low. We see a great unmet medical need here and an opportunity to improve outcomes for patients.

Many of us at Assembly Bio were part of the efforts to develop functional cures for hepatitis C, and we are working towards a parallel vision for hepatitis B. If patients achieve functional cure, they would no longer have detectable viral levels and we would expect, based on experience with other viruses (and based on the experience with chronic suppressive therapy in HBV and other viruses that reduced viral loads reduces infection rates), that they would no longer be able to infect others as well as result in improved prognosis for patients (lower lifetime risk of developing serious liver disease including fibrosis, cirrhosis and hepatocellular carcinoma). And, with a finite treatment/functional cure approach, we would also expect, as was the case with hepatitis C, that we can reach additional patients for whom a long-term chronic treatment may not be feasible, thus also reducing the infection disease burden and transmissibility overall.

Our HBV/HDV entry inhibitor program targets hepatitis delta coinfection in patients with HBV. HDV infection only occurs with HBV infection, with an estimated prevalence of 4.5%, but is responsible for a significant portion of the cirrhosis and liver cancer associated with HBV, around 20%. This is the case even when the patient is receiving standard of care treatment for HBV. Our goal for our HBV/HDV entry inhibitor program is to provide a treatment that lowers viral loads for HDV specifically, to help address this significant disease burden for patients with HDV. From an infection prevention standpoint, we would expect based on experience with chronic suppressive therapy for other viruses that lowering the viral load would also reduce transmissibility here as well.

 Across the data presented from Assembly Bio’s programs, there were a number of insights for which we were seeing data for the first time and that will play an important role in informing our clinical development strategy for each of these approaches and investigational therapies.

 highlighting data from our next-generation core inhibitor, ABI-4334 (4334), this in vitro study was the first to demonstrate the potential of core inhibitors to inhibit double-stranded linear (DLS) DNA being delivered to the nucleus of hepatocytes; DLS HBV can be integrated into the human genome, so we are excited that this property of the compound may subsequently translate into limiting or preventing HBV integration. HBV integration is hypothesized to be a significant contributor to HBV-induced hepatocellular carcinoma (HCC). Additionally, phase 1 clinical data presented at the meeting from others in the field showed that short term treatment with core inhibitors may reduce circulating levels of Hepatitis B surface antigen (HBsAg)–a marker of cccDNA (viral reservoir) and currently a key endpoint for functional cure studies. These data are of interest to our 4334 development program as they support the potential for highly potent core inhibitors such as 4334 to have a meaningful clinical impact on the key endpoints.

Relative to our small molecule interferon-α receptor (IFNAR) agonist program and the data presented in our poster at AASLD, I noted with great interest the broad prevalence of Peginterferon α (PEG-IFN) in current and planned HBV cure studies. There is a clear industry focus – and demonstrated scientific support for – the role that PEG-IFN could play in finite and curative therapies for hepatitis B. Our IFNAR program builds upon this scientific rationale, evaluating a class of compounds that we hope will overcome the significant tolerability issues that have, to date, limited the utility and enthusiasm for using PEG-IFN in HBV cure combination studies.

 highlighting the preclinical characterization of potent, orally bioavailable viral entry inhibitors for HBV and hepatitis D virus (HDV)we were highly encouraged by the rapid progress on our program and the highly potent activity achieved preclinically. Based on the potency and pharmacokinetic properties of our entry inhibitors we are optimistic that molecules from this program can be optimized for once-daily oral dosing which would overcome the inconvenience of the daily injectable therapy (bulevirtide) recently approved in Europe for HDV patients. We were also encouraged by new data presented at the meeting from bulevirtide, which targets the same viral entry mechanism as our program. These new data demonstrated that real world experience aligned with clinical studies–which is particularly notable because it shows us that there is high compliance among patients–and also showed durable efficacy for the entry mechanism of action even when looking at a longer period of almost 1.5 years.

Overall, we were glad to hear feedback from the scientific community at AASLD–and also see data from other studies that validate our approaches– and we are proud about how far that we’ve come in short time with our preclinical and clinical programs.

: What, if any, future research will there be related to these results?

For 4334, we have initiated a Phase 1a clinical study for this candidate and look forward to the data readout from that study in healthy volunteers in the first half of 2023.

For our HBV/HDV entry inhibitor and IFNAR agonist programs, both of these are progressing in preclinical studies. Assembly Bio anticipates advancing 2 of our research stage programs (which include these 2 programs as well as 2 additional programs) into development candidates next year. We are focused on progressing our programs rapidly and will plan to provide updates at future scientific conferences.

: Is there anything else that you would like to add?

 We are really excited to see our next generation, more potent core inhibitors progress in the clinic. In addition to 4334, we have another next-generation core inhibitor, ABI-H3733, in a phase 1b study in patients with chronic HBV, and that study is on track to have initial data by the end of this year. We expect full data readouts from the 3733 Phase 1b study and the 4334 phase 1a study in the first half of next year. These next-generation core inhibitors have significantly increased potency against cccDNA formation, in particular, and we are looking forward to seeing clinical data from these programs as they progress.

We also thought this year’s AASLD was an exciting meeting with a lot of enthusiasm for advancing novel treatments for both HBV and HDV–it was great to see the academic and pharma communities coming together to present and discuss new clinical data and how to continue to move forward together as a field.

 for giving us an opportunity to speak to your readers. Our mission is to develop innovative, investigational therapeutics targeting HBV and other serious viral diseases. One of the compelling aspects of working in therapeutics for viral disease is the ability to have an impact on treatment for patients facing significant disease burden and at the same time potentially reduce transmission and the population burden of the disease as well, and we appreciate your interest in our research and programs.

While treatments are available for hepatitis B virus, no long-term cure has been developed. Progress so far indicates that this core inhibitor candidate is potentially ready for clinical studies. 


Potential Core Inhibitors in Hepatitis B Virus Presented at the AASLD, The Liver Meeting

Moderna announced today that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) triggered a superior antibody response compared to a booster dose of mRNA-1273, also known as Spikevax, against Omicron (BA.1 and BA.4/BA.5) in phase 2/3 clinical trials.

“We are pleased to see that both of our bivalent booster vaccine candidates offer superior protection against Omicron BA.4/BA.5 variants compared to our original booster, which is encouraging given COVID-19 remains a leading cause of hospitalization and death globally. In addition, the superior response against Omicron persisted for at least three months after the mRNA-1273.214 booster," Moderna Chief Executive Officer Stéphane Bancel, said in a statement. "Our bivalent boosters also show, in research assays, neutralizing activity against BQ.1.1, an increasingly dominant emerging variant, confirming that updated vaccines have the potential to offer protection as the virus continues to evolve rapidly to escape our immunity."

In a phase 2/3 study, a 50 µg booster dose of mRNA-1273.222 elicited a superior neutralizing antibody response against Omicron BA.4/BA.5 variants when compared to a 50 µg booster dose of mRNA-1273 in 511 previously vaccinated and boosted participants (ages 19-89 years). The participants received mRNA-1273.222 and mRNA-1273 approximately 9.5 months and 4.5 months after their prior vaccination, respectively.

Pre-booster BA.4/BA.5 titers were similar between the mRNA-1273.222 and mRNA-1273 groups. The Omicron BA.4/BA.5 geometric mean titer (GMT) ratios of mRNA-1273.222 versus mRNA-1273 were 5.11 (95% CI: 4.10, 6.36) and 6.29 (95% CI: 5.27, 7.51) for participants with and without SARS-CoV-2 infection pre-booster, respectively. In all participants the GMT against Omicron BA.4/BA.5 was 4289 (95% CI: 3789.0, 4855.9) representing a 15.1-fold increase (95% CI: 13.3, 17.1) from pre-booster levels.

For participants without prior infection, the GMT was 2325 (95% CI: 1321.2, 2812.7), representing a 26.4-fold increase (95% CI: 22.0, 31.9) and for those with prior infection, the GMT was 6965 (95% CI: 6043.7, 8025.4), representing a 9.8-fold (95% CI: 8.4, 11.4), increase from pre-booster levels.

Investigators point out the results were consistent between participants aged 65 years and older and those aged 18 to 65.

This builds upon 

 that confirmed superiority of the company's BA.1 bivalent vaccine, mRNA-1273.214, neutralizing titers against multiple Omicron variants compared to a booster dose of mRNA-1273.

According to investigators, the frequency of adverse reactions with mRNA-1273.222 and mRNA-1273.214 were similar or lower than that of either a second or third dose of the original vaccine.

Additionally, they did not identify any new safety concerns after approximately one month and three months of follow-up. According to Moderna, these safety and immunogenicity data will be submitted for peer-reviewed publication and shared with regulators globally.

No new safety concerns with this COVID-19 vaccine were reported. 

Spikevax Booster’s Efficacy Falling Behind Omicron-Targeting Booster Candidates

Hebah Ibrahim Al Zamel, MSN, CIC, CPHQ, spoke to 

Association for Professionals in Infection Control and Epidemiology’s (APIC’s) Cleaning, Disinfection, Sterilization Conference

 (CDS) was held virtually on November 10 and 11, 2022. platform and session recordings will remain available to attendees and exhibitors until February 28, 2023. Hebah Ibrahim Al Zamel, MSN, CIC, CPHQ, health care policy consultant, infection control preventionist, and a member of the APIC CDS Education Committee spoke to 

) about the presentations that she monitored.

: How did you get involved with the 2022 CDS Committee?

Hebah Ibrahim Al-zamel, MSN, CIC CPHQ: I am from Jordan, and currently I work in Dubai at the Emirates Health Services, I hold an MSN, CIC, CPHQ, am a member of APIC. I was selected to work with the Education Committee, and I am luckyto have been chosen from among hundreds of applicants. I am also lucky to be part of the wonderful committee that prepared for the event.

: What is the emphasis of this year’s fall conference?

 This interactive conference provides infection preventionist an opportunity to explore fundamental challenges, emerging issues, and practical strategies and solutions in the critical infection prevention and control areas of cleaning, disinfection, and sterilization.

: How does infection prevention and control differ in Dubai than here in the United States?

 The United Arab Emirates works on disease prevention and control through several measures which include implementing laws and resolutions on combatting communicable diseases, reporting communicable diseases, setting a national policy for disease prevention, and introducing health and vaccination programs. In recent years a greater focus on improved clinical practice relating to infection prevention and control and significant advances in technology has led to better outcomes for patients.

: Which presentations will you be monitoring, and what do you hope the attendees will take away from the presentations?

 I monitored the following presentations:

“Standards in Focus: Key Updates In ANSI/AAMI ST91 and Other Standards on the Horizon,”

“A Useful Guide: Everything You Need to Know about UV-C Disinfection,”

“Colorized disinfection method improves cleaning efficacy: results from three hospital studies and a meta-analysis of the link between cleaning efficacy and reduced healthcare associated infections,” and

“The role of technology and innovation and patient safety.”

I hope the attendees will take away from the presentations last evidence-based practices in this topic. 

: Do you have anything else you would like to add?

 I hope this event [was] successful. I would like to thank the distinguished committee for all the efforts made, and I thank 

Hebah Ibrahim Al Zamel, MSN, CIC, CPHQ, currently living in Dubai discusses becoming a member of the APIC CDS Education Committee and what infection prevention is like in Dubai. 


IP in Dubai Speaks About APIC’s Cleaning, Disinfection, Sterilization Conference

’s) wide-ranging coverage of the infection prevention and control world. Everything from interviews with known opinion leaders, to the news that infection preventionists and other health care professionals can use on their jobs.

Respiratory Spread and the Flawed Concept of Immunological Debt: A New Understanding

CDC discusses potential proposals to redefine spread and to produce uniform guidelines across different types of facilities because public health interventions do not cause immunological debt but instead may prevent immunocompromising infections.

Sequencing-Based Diagnostics Critical to Fighting Against Infectious Disease

While sequencing-based diagnostics have been used since the 1970s, only recently has the technology been used for infectious diseases.

Sexually Transmitted Infections Increasingly Plague the United States

What can the individual do, especially those who are underserved, to protect themselves against sexually transmitted infections, including chlamydia, gonorrhea, and syphilis, and complicated with monkeypox.

APIC’s Virtual Cleaning, Disinfection, and Sterilization Conference Promises Learning and Fun

Association for Professionals in Infection Control and Epidemiology’s (APIC’s) CDS Conference is virtual this year, and the topics are environmental hygiene and sterile processing. 

Developing Vaccines to Fight Sepsis Caused by ExPEC and S aureus

Extra-intestinal pathogenic Escherichia coli (ExPEC) and Staphylococcus aureus (S. aureus) are 2 of the leading causes of severe sepsis, and Janssen Pharmaceutical Companies of Johnson & Johnson is developing vaccines to fight those diseases.

Take 5 minutes to catch up on Infection Control Today’s highlights for the week ending November 11, 2022.

Weekly Rounds: Immunological Debt, Sequencing-Based Diagnostics, and More

Saskia v. Popescu presents Hot Topics in Infection Prevention

. But the future of COVID-19 heavily discussed, and, of course, infectious diseases don’t take a break.

Good news: globally, COVID-19 cases and deaths are dropping in most of the world. Bad news: except in Southeast Asia and the Western Pacific, which are reporting increasing cases. Last week, the world saw 2.1 million new cases, which is 

 than the week before. Unfortunately, those countries with the most new cases include Japan, South Korea, the United States, Germany, and China. China is still pursuing the “zero-COVID[-19]” strategy, which has many individuals frustrated with continued shutdowns and surges. In the United States, COVID-19 cases are up 7% in the last 2 weeks, with a daily average just over 40,000 cases. Test positivity is 8.8%, and there are roughly 316 daily deaths. Some states in the US are still showing a consider up-tick in cases: the 4 Corners (Arizona, New Mexico, Colorado, and Utah) are all showing at least a 30% increase in cases, with other states slowly climbing up, such as South Carolina, Oregon, Nevada (up 96%!), and Louisiana. Not all states are climbing, though; Oklahoma is down in cases by 25%, similar to Michigan and New Hampshire.

 was released on how Paxlovid may help cut the risk of long COVID-19 and a great article on how 

annual COVID-19 shots may make our lives easier

. If you’re interested in global health news and articles on vaccine equity, 

 on vaccine hoarding and the impact globally.

It seems a while since we’ve had to respond to what felt like a true respiratory virus season while tackling the COVID-19 pandemic. Unfortunately, we’re seeing that now. Some states are reporting influenza test positivity rates upwards of 20%, and significant regions in the United States are seeing H1N1 activity rise. The Centers for Disease Control and Prevention’s 

 went out last week as well, giving health care providers strategies for treating, testing, and combating respiratory viruses on the move.

Good News Against Urinary Tract Infections (UTIs)

Two clinical trials for an investigational antibiotic for UTIs were halted earlier than expected due to meeting their goals head of schedule. The British pharmaceutical company, GSK, “

 the decision to stop enrollment for the EAGLE-2 and EAGLE-3 trials, which were evaluating the novel oral antibiotic gepotidacin for treatment of uncomplicated UTIs in adult and adolescent women, was based on a pre-specified interim analysis of efficacy and safety data by the Independent Data Monitoring Committee. The interim analysis found that gepotidacin met the combined primary efficacy endpoint in both trials, which included more than 3,000 patients in 12 countries.”

The outbreak of Ebola in Uganda has now hit 136 confirmed cases and 53 deaths, with projections as high as 1,200 by April. Most cases have been in the capital city of Kampala and World Health Organization's Director-General Tedros Ghebreyesus 

 about the focused efforts and ensuring support for contact tracing, infection prevention, and community engagement. During this time, 

 gone up as 19 countries report a rise in cases. In general cases are down significantly from the peak in August, but the WHO has reported a 2.5% increase in cases for the last week, most heavily in the Americas and European regions.

Infection prevention and control personnel don't elect to ever stop. Dr. Popescu tells us what's in the news this week of the mid-term elections.

Hot Topics in IPC:  Mid-term Election Week

Sepsis is all-too-often deadly. (Adobe Stock) 

 is a constant danger to patients’ lives. Sepsis occurs when an infection a patient already has generates an overactive chain reaction throughout the patient’s body, leading up to tissue damage, organ failure, and all-too-often, death. Both bacteria and viruses can lead to sepsis; although, bacteria are the most common. Investigators don’t understand why the body’s immune system turns from fighting the pathogens to fighting itself, which is the beginning of sepsis.

Medical professionals should look out for 

, the 4 warning signs: Temperature, Infection, Mental decline, and Extremely ill. Sepsis is a medical emergency the same as a heart attack or stroke and must be addressed as soon as possible to have a chance at survival.

Severe sepsis has the regular signs of sepsis, but also difficulty breathing, low or no urine output, abnormal liver tests, and changes in mental status. Because of the severity of the symptoms, nearly all patients who reach this stage need treatment in the intensive care unit.

) are 2 of the leading causes of sepsis, and investigators are searching urgently for vaccines for these diseases. Jan Poolman, PhD, senior vice president, head of Bacterial Vaccines Discovery and Early Development at Janssen Pharmaceutical Companies of Johnson & Johnson, Netherlands, answered questions from 

) about the ongoing research he leads through the bacterial vaccines team, which focuses on developing vaccines against the most prevalent antibiotics resistant bacteria.

: Medical professionals are constantly on alert for signs and symptoms of sepsis. What are the risks and burdens associated with sepsis?

Sepsis is a life-threatening reaction to an infection that can lead to tissue damage, organ failure and even death. It is becoming increasingly more difficult to treat, particularly in light of antimicrobial resistant (AMR) pathogens, and sepsis-related infections cause more than 11 million deaths worldwide each year.

 are two of the leading causes of sepsis. Would you mind expanding on why innovative solutions is urgent for them?

 have become resistant to antimicrobial treatment, making those pathogens even more difficult to treat and manage. In fact, invasive ExPEC disease (IED) is one of the most common causes of death due to AMR infection. We must explore and develop more effective ways of dealing with AMR infections, including through innovative vaccines and therapeutics, as well as antibiotic stewardship efforts to limit the development of more AMR pathogens.

Janssen is one of the few companies prioritizing the development of vaccines to protect people from ExPEC and S. aureus, the two leading causes of sepsis.

: What should infection preventionists, in particular, be mindful of to prevent these infections from occurring?

The only way to prevent sepsis is by preventing infection. This can be done by:

Getting vaccinated against COVID-19, influenza, and other preventable infections,

: What is the Janssen Pharmaceutical Companies of Johnson & Johnson specifically doing to combat these infections?

Vaccines have a strategic role to play in the fight against AMR, and Janssen continues to prioritize the development of new vaccines to protect people from invasive ExPEC disease (IED) and 

 infection. Through new scientific approaches, we aim to reduce the potentially devastating consequences of bacterial infections, dependency on antibiotics and, ultimately, the risk of AMR.

Our ExPEC vaccine candidate ExPEC9V, currently in Phase 3 development, is an investigational vaccine for the prevention of invasive ExPEC disease (IED), including sepsis and bacteremia, caused by some of the most prevalent serotypes of E. coli.

We have also initiated the development of a 

: Do you have anything else you would like to add for 

The growing prevalence of AMR and the increase in elderly individuals worldwide are critical factors that increase the burden of sepsis, one of the leading causes of death globally in adults and children alike. The World Health Organization asks for better data, more awareness and quality care, along with medicines and vaccines.

Extra-intestinal pathogenic Escherichia coli (ExPEC) and Staphylococcus aureus (S. aureus) are 2 of the leading causes of severe sepsis, and Janssen Pharmaceutical Companies of Johnson & Johnson is developing vaccines to fight those diseases.


Developing Vaccines to Fight Sepsis Caused by ExPEC and S. aureus 

Isis Lamphier, MPH, CIC, is an infection preventionist at Moffitt Cancer Center in Tampa, FL.

 (CDS). This year, the conference will be held virtually on November 10 and 11, 2022. The interactive conference was previously planned to be held in Boston, Massachusetts, but due to ongoing travel restrictions, public health concerns, and rising air travel costs, the conference is now 100% virtual.

The 2-day format features multiple live sessions, keynote sessions, and workshops on a very organized and easy to navigate virtual platform. There is even a live networking event scheduled for the first day of the conference. All participants have a conference profile that displays virtual badges and information regarding themselves. It is very interesting the digital transformation that has occurred after the pandemic! Participants will also have access to exhibitors and sponsors and product showcases. All eligible participants will earn continuing education credits for participating in the conference; this is very helpful, especially if you require continuing education credits for renewing a health care license. You can earn up to 13.5 CNE credits and 10 IPUs for attending the conference.

The conference includes innovative sessions on IFUs (instructions for use), environmental cleaning, survey readiness, high-level disinfection and sterilization, and more. From an infection preventionist’s (IP’s) point-of-view, I believe this conference would be very beneficial to all IPs, especially those individuals desiring to expand their knowledge regarding the sterile processing department (SPD), environmental services (EVS), and the operating room (OR). These 3 departments are critical to all hospitals, and there are always new concepts and products to learn as these areas continually evolve. This learning opportunity would also be useful and constructive for preparing facilities for upcoming The Joint Commission surveys. Some of the sessions that I plan to attend include, “Fluorescing the Hawthorne effect: Highlighting the importance of the use of fluorescent marking technique in operating room terminal clean audits,” “How Laundries Disinfect Healthcare Textiles,” and “High Level Disinfection Analysts in a Central Sterile Processing World: A ‘Tell’ of a Quality Assurance Program.” These sessions sound very informative and innovational.

The list of exhibitors for this conference includes CBIC (Certification Board of Infection Control), Diversey, UVDI, Rubbermaid, GOJO Purell Healthcare, and more—all are recognized brands in health care settings. Attendees of the Cleaning, Disinfection, Sterilization Conference will have access to resources and contact information for each exhibitor. For something fun, there is also a scavenger hunt in which participants are encouraged to answer questions regarding the CDS Exhibitor Booth to play and win prizes.

If you are unable to attend the CDS Conference live on November 10-11, 2022, the platform and session recordings will remain available to attendees until February 28, 2023. This will also allow participants to return to their favorite sessions and review them once more. Attendees who join the conference live will be able to interact with session speakers and ask questions in real-time during live sessions.

This conference will help IPs to expand their knowledge, gain insight into the latest technologies and recommendations, and network with other professionals in the field. Attending a conference fosters new creative thoughts, enables individuals and teams, and further advances fields, including the field of infection prevention and control. If you are unable to attend this conference, I encourage you to attend one in the future for professional and personal development!

For more information regarding the conference visit: 

Association for Professionals in Infection Control and Epidemiology’s (APIC’s) CDS Conference is virtual this year, and the topics are environmental hygiene and sterile processing. 


Sexually transmitted infections are on the rise. Condoms help prevent them. (Adobe Stock) 

The rise of sexually transmitted infections (STIs) afflicts the United States creating a significant health crisis. This increase is within the most vulnerable and underserved populations.

Katherine Danaher, BSc Hons, research and development scientist at binx health, a Boston-based organization that is working on assisting the individual to take control of their health care decision-making, answered 

’s) questions about the rise of STIs and how to diagnose and treat the infections before they worsen or spread to other individuals.

: A significant health crisis is plaguing the US, the rise of sexually transmitted infections (STIs), largely due to lack of education, testing, and diagnosis. Would you expand on that point?

 Sexually transmitted infections (STIs) are increasing year on year, with preliminary data suggesting that in the US in 2021, there were around 2.5 million reported cases of 3 of the most common STIs: chlamydia, gonorrhea, and syphilis.

 The COVID-19 pandemic affected STI surveillance activities and is likely to have exacerbated this upwards trend, with a global breakdown of accessibility to health care.

With the restabilizing of health care infrastructure post-pandemic, the population can be divided into 3 groups: those who do not get tested, those who are misdiagnosed, and those who do not follow through with treatment.

Accessibility to health care can be a large contributing factor to those not tested, irrespective of education. First, not all STIs are symptomatic; people often avoid being tested for these infections and may not even realize they carry them. Second, with all the best intentions, a symptomatic individual may also run a busy life, where a visit to a clinic and potential follow-up consultations may never feel like the right time. The above group may also fall into the category of those who are unlikely to attend follow-up appointments and treatment, again for the same reason.

For those who can make it to a clinic, the turnaround time between sample collection and patient results can be up to a week or more. This often leads to clinicians treating their patient’s symptoms empirically, to prevent further spread, by prescribing medication prior to the arrival of these results. This potentially inappropriate treatment may lead to antimicrobial resistance, an ever-growing problem in the world of infectious diseases. For instance, antimicrobial resistance has led to gonorrhea having in many cases only 1 effective treatment option left.

 Additionally, early misdiagnosis delays any investigation and appropriate treatment of the true infection present.

Overall, there are many points in the chain to effectively diagnose and treat STIs that can break down—and historically have—leading to the current STI epidemic we face.

: How is monkeypox increasing this situation?

Monkeypox can be spread by skin-to-skin contact including transmission via sexual intercourse.

 Monkeypox can also present symptoms considered characteristic of other STIs, such as genital blisters and rashes.

 This can complicate diagnoses when based on symptoms, additionally sharing behavioral modes of transmission with STIs.

Despite their similarities, STIs and monkeypox require different immediate actions, with monkeypox requiring isolation prior to a health care visit, because of the wider scope of transmission.

 Accurate and reliable laboratory identification is therefore essential to distinguishing the causative microbe and selecting the most effective treatment for the patient.

: What is binx doing to alleviate this situation?

binx health is providing a catch-all approach to fighting the STI crisis currently faced by targeting the gaps in the chain to effective diagnosis and treatment. 

 is a physician-mediated digital platform that combines self-collection of samples and high-quality diagnostic testing performed by a network of third-party laboratory partners and clinicians. binx 

 enables programs that distribute self-collection kits tailored to the individual’s needs, delivered straight to a patient to provide convenient and discreet self-collection. This method reaches those who cannot attend a physical clinic visit. These samples are sent to a reference laboratory, after which a clinician will review the result, and work with the patient using an online portal to deliver the most appropriate care.

 is the first Food and Drug Administration-cleared, Clinical Laboratory Improvement Amendments (CLIA) -waived molecular point-of-care (POC) test for chlamydia and gonorrhea for males and females, delivering accurate results in 30 minutes. This enables same-visit test and treat, helping prevent misdiagnosis, inappropriate treatment, and address those who do not attend follow-up appointments. Being CLIA-waived, our instrument and the chlamydia and gonorrhea test cartridge can be operated in any establishment possessing a CLIA certificate of waiver, delivering an accurate laboratory-quality result from sample collection in a single patient visit. This removes the need to transport the sample to a reference laboratory, joining a long queue of incoming tests, before entering a long list of results for the clinician’s interpretation. With the binx 

, in 1 visit, the patient can be rapidly tested, diagnosed, and correctly prescribed with the most appropriate treatment, empowering both the clinician and the patient.

Even if the patient tests negative for the infections tested, this rapid testing allows the clinician to re-assess the symptoms and seek the appropriate means of diagnosis and treatment. This prioritizes the patient’s needs and prevents further transmission, while combatting antimicrobial resistance that could arise from inappropriate treatment.

: Do you have anything you’d like to add?

 Conventionally, there has unfortunately been a stigma surrounding STIs. Improving both accessibility to testing and education, prevention, and treatment options available will help fight this, encouraging both conversation and routine screening. The harsh truth is that STIs are increasingly common, and therefore, transmission is increasingly likely also. If left untreated, these infections can cause serious implications, including susceptibility to other infections such as human immunodeficiency virus (HIV), and other outcomes such as infertility and pelvic pain.

The multi-pronged approach provided by binx health aims to equip both the clinician and the patient with accurate and reliable information, how, where and when they need it. We listen to the needs of clinicians and patients to determine what tests they desire and research how best we can help make an impact.

We aim to help individuals seek care in the way they want to, as easily as possible, integrating access to high quality health care into their day-to-day lives, regardless of circumstance. It is only when this becomes the reality and norm, that a reduction in the STI crisis can be expected.

1. Centers for Disease Prevention and Control (CDC). Preliminary 2021 STD surveillance data. Published September 1, 2022. Accessed October 04, 2022. https://www.cdc.gov/std/statistics/2021/default.htm

2. WHO. Antimicrobial resistance. Accessed October 4, 2022. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

3. CDC. Monkeypox in the US Centers for Disease Control and Prevention. Published October 04, 2022. Accessed October 04, 2022. https://www.cdc.gov/poxvirus/monkeypox/if-sick/transmission.html

4. CDC. Monkeypox in the US Centers for Disease Control and Prevention. Published October 04, 2022. Accessed October 04, 2022. https://www.cdc.gov/poxvirus/monkeypox/symptoms/index.html

5. CDC. What to do if you have monkeypox. Centers for Disease Control and Prevention. Published August 11, 2022. Accessed October 04, 2022. https://www.cdc.gov/poxvirus/monkeypox/if-sick/what-to-do.html

6. National Coalition of STD Directors. "Chlamydia, gonorrhoea & syphilis: STDs on the rise," 06 February 2022. Online. Accessed 04 October 2022. https://www.ncsddc.org/wp-content/uploads/2018/09/STD-101_NCSD-STD-Handout-2.3.2020.Final_.pdf.

What can the individual do, especially those who are underserved, to protect themselves against sexually transmitted infections, including chlamydia, gonorrhea, and syphilis, and complicated with monkeypox.


Sequence-based diagnostics was developed in the 1970s, and since then has been used to in the medical field to diagnose cancers and other diseases. However, until recently, it hadn’t been used for infectious diseases. 

 is changing that status quo. It is an early-stage company developing a new category of diagnostics for infectious disease to identify pathogens and antibiotic susceptibility profile using whole genome sequencing and machine learning in hours instead of the usual days.

Jong Lee, chief executive officer, Day Zero Diagnostics, spoke to 

) about the company’s goals for assisting the general health care space, and their special announcement at the 

 in Washington, DC, on October 19-23, 2022.

The company announced at ID Week Conference that they received awards from CARB-X totaling over $16 million this year.

Lee said, “Sequencing-based diagnostics have been something that people have talked about for decade, and sequencing-based diagnostics have become clinically useful in some categories, like oncology or prenatal testing, but they have not made a dent in infectious diseases. Sequencing is used for research purposes or to do research projects. But it's not actually integrated into clinical decision-making when you're talking about care of patients.”

Sequencing-based diagnostics is even more critical to use to fight against infectious disease, especially since antimicrobial resistance expands. “The other takeaway is about things like outbreak detection and infection control. If you walk around IDWeek [conference], you see a lot of presentations about that. Almost every single presentation that's now being given has sequencing as the core method by which people make that determination. In fact, if you're not using sequencing, what's clear from the presentations being given here is that you're not state of the art anymore.”

Lee then discussed what is limiting his company thus far.“But most practitioners think of sequencing again just as a research tool, something that academic researchers are doing and presenting their work in a place like IDWeek, they don't realize that it's available today as a commercial service. And that's where [Day Zero Diagnostics] do a lot of our efforts around diagnostic development. Earlier this year, we'd launched a commercial service that's available to any hospital, where within 2 days, we provide sequencing-based determinations of commonality, so that hospitals can make a really informed decision when they're trying to implement, expensive protocols, expensive ways to deal with an outbreak.”

 asked Lee what he hoped the attendees took away from his presentation, he said, “One message to take away both from us and our announcements [of additional funding from CARB-X] and some of the presentations that we've been involved in, but others as well, is that we're in a zone where in the next 3 to 5 years, sequencing-based diagnostics are going to become reality for clinical microbiology and infectious diseases. That's something that people have talked about already for a decade, but it's getting to the point where the technology is maturing, and costs are getting to the point where I think sequencing is going to be the future of the way infectious disease diagnostics are done going forward.”