HPV Vaccine Used Overseas Passes Safety Test in Boys

New industry-supported research from Finland suggests that Cervarix, an HPV vaccine given to girls in Europe and elsewhere, is safe for boys as well.

“The results show that the vaccine does generate an immune response and is generally well-tolerated,” said study co-author Gary Dubin, MD, of vaccine maker GlaxoSmithKline.

It is not clear, however, whether health officials will push for males to receive the vaccine on a regular basis.

At issue is the human papillomavirus, which causes cervical cancer in females. Much more rarely, the virus can cause diseases in men, including oral and throat cancer, penile cancer and anal cancer. Gay men are at an especially high risk.

Cervarix, a HPV vaccine that GlaxoSmithKline produces, protects against strains of the virus that causes 70 percent of cervical cancer cases, said Dubin, who is director of the pharmaceutical company’s Global Clinical Development Center

In the study, the first to look at the safety of the vaccine in males, researchers randomly assigned healthy Finnish males ages 10 to 18 to receive either Cervarix or a hepatitis vaccine (as a control).

The findings appear online in the Journal of Adolescent Health.

Judging by tests of the immune systems of the 181 males who received it, Cervarix was effective, but individuals who received it were more likely to report pain and swelling after injections.

“Based on research with other vaccines...we could not assume that boys and girls would respond similarly,” Dubin said. “We needed to conduct a clinical study to gather the evidence.”

Scientists still do not know if vaccinating males will prevent them from transmitting HPV to females, Dubin said. Another Finnish study, which researchers will complete in 2014, will help resolve that issue, he said.

Several countries are considering whether to give HPV vaccines to males, said Anna Giuliano, chair of the Department of Epidemiology and Genetics at H. Lee Moffitt Cancer Center in Tampa, Fla. Their decisions, she said, depend on “several factors, such as the burden of disease in males and females related to the types included in the vaccine, the feasibility of reaching large proportions of the male and female population with vaccination and the cost-effectiveness of a universal vaccination strategy.”

Clinicians in the United States give another vaccine, Gardasil, which protects against a larger number of strains of HPV. Gardasil also provides some protection against genital warts in females, and a study released last month suggests it helps prevent genital warts in males too. Cervarix, by contrast, does not provide protection against warts.

Reference: Petaja T, et al, Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10–18 Years, J Adolesc Health online, 2008.