Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years

Petäjä, Tiina; Keränen, Heli; Karppa, Tiina; Kawa, Anna; Lantela, Sirkku; Siitari-Mattila, Mari; Levänen, Helena; Tocklin, Tuomas; Godeaux, Olivier; Lehtinen, Matti; Dubin, Gary

doi:10.1016/j.jadohealth.2008.10.002

« Previous Next »Journal of Adolescent Health
Volume 44, Issue 1 , Pages 33-40, January 2009

Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years

Tiina Petäjä, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Heli Keränen, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Tiina Karppa, M.D.
- University of Tampere, Medical School, Tampere, Finland
Anna Kawa, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Sirkku Lantela, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Mari Siitari-Mattila, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Helena Levänen, M.D.
- Mikkeli Municipal Health Center, Mikkeli, Finland
Tuomas Tocklin, M.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
Olivier Godeaux, M.D.
- GlaxoSmithKline Biologicals, Rixensart, Belgium
Matti Lehtinen, M.D., Ph.D.
- School of Public Health, 33014 University of Tampere, Tampere, Finland
- Address correspondence to: Matti Lehtinen, M.D., Ph.D., School of Public Health, University of Tampere, Sorinkatu 1, 33014 Tampere, Finland.
Gary Dubin, M.D.
- GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania

Received 8 July 2008; accepted 6 October 2008.

Abstract

Purpose

The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix™) has been shown to be well-tolerated and immunogenic in females aged 10 to 55 years, and up to 100% effective for the prevention of HPV-16/18 infection and associated precancerous cervical lesions in females aged 15 to 25 years. This study is the first to evaluate the immunogenicity and safety of the vaccine in males.

Methods

Healthy males aged 10 to 18 years were randomized (2:1 ratio) to receive HPV-16/18 AS04-adjuvanted vaccine (n = 181) or hepatitis B virus (HBV) control vaccine (n = 89) at 0, 1, and 6 months, and were followed for 7 months.

Results

All initially seronegative subjects in the HPV-16/18 group seroconverted for HPV-16 and 18 (ELISA) at month 2. At month 7, all subjects were seropositive, and the HPV-16 and -18 antibody levels were, respectively, four- and twofold higher than at month 2. The anti-HPV-16 and -18 antibody responses for males aged 10 to 18 years and 10 to 14 years, respectively, were higher than those reported for females aged 15 to 25 years and 10 to 14 years, respectively, in a previous study. The reactogenicity profiles of the HPV-16/18 AS04 and HBV vaccines were similar, except that pain and swelling at the injection site were more common in the HPV-16/18 group. However, vaccine-related symptoms did not affect compliance with the three-dose course, which was equally high (97%) in both groups.

Conclusions

The HPV-16/18 AS04-adjuvanted vaccine is immunogenic and well tolerated in boys aged 10 to 18 years. However, further data on the potential public health benefits of vaccination of boys are required before any recommendations can be made.

Keywords: Human papillomavirus, Cervical cancer, Vaccine, Immunogenicity, Male, Adolescent