EMERYVILLE, Calif. -- Chiron Corporation announces it is initiating plans for a registration trial in the United States for Menjugate, the company's conjugated vaccine for the prevention of meningococcal C disease. The company expects to begin this Phase III trial this year.
"We believe that Menjugate could fill an important medical need in the United States," said John Lambert, president of Chiron Vaccines. "Chiron is committed to reducing the toll from meningococcal infection through the development of vaccines to address the five key serogroups that cause it."
Neisseria meningitidis causes an estimated 120,000 cases of bacterial meningitis and sepsis worldwide each year, including 3,000 in the United States. The fatality rate from the disease is 10 percent to 15 percent. Among survivors, an additional 11 percent to 19 percent have significant sequelae, including neurologic disability, limb loss, or hearing loss. Meningococcal meningitis is primarily caused by five serogroups: A, B, C, Y and W-135. An estimated 150 million people worldwide would benefit from a catch-up campaign for preventive vaccines against meningococcal disease.
Conjugate vaccines confer long-lasting protection through induction of immunological memory. In universal vaccination campaigns in the United Kingdom and Quebec, Menjugate has helped reduce deaths from meningococcal C disease by 80 percent. The vaccine is currently approved for use in infants through adults in 24 countries worldwide.
Chiron has vaccines in development for the five most common meningococcal serogroups known to cause human disease. No broad-coverage vaccine currently exists to prevent meningococcal B infection. Results of a Phase I trial of a recombinant meningococcal B vaccine are currently under evaluation. Clinical trials are also underway in New Zealand to test a vaccine specific to the strain of meningococcus B endemic in that country.
In addition, Chiron has a combination vaccine against serogroups A, C, Y and W-135 in development. The company is currently evaluating data from the completed Phase I trial for this vaccine.
Source: Chiron Corporation