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

doi:10.1016/j.jadohealth.2008.10.002

Journal of Adolescent Health

Volume 44, Issue 1, January 2009, Pages 33-40

https://doi.org/10.1016/j.jadohealth.2008.10.002 Get rights and content

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.

Section snippets

Study participants and ethics

The study (580299/011/NCT00309166) took place from April 2006 to January 2007 at seven study sites in Finland. Study participants were recruited by population-based recruitment letters sent to the entire target male birth cohort (parents or legal guardian in the case of minors) in the study site communities by the population census register and by school recruitment sessions. All distributed material had received prior approval by the Ethical Review Committee of the Pirkanmaa Hospital District

Results

A total of 270 participants (HPV-16/18 group, n = 181; HBV group, n = 89) were enrolled and vaccinated over a period of approximately 2 months (April 5 to June 10, 2006). Study compliance was excellent (Figure 1), and 97% of boys in both groups (HPV-16/18 and HBV) received all three vaccine doses. The demographic profile of the two groups was similar. In the total vaccinated cohort the mean age of boys was 14.4 years. As this was a study in one country only, the distribution of ethnicity was

Discussion

This is the first study in which Cervarix™ has been administered to boys. This HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic, inducing seroconversion for both antigens in all boys and very high antibody titers for both HPV-16 and HPV-18. The immune response was shown to be noninferior in terms of seroconversion rates between boys aged 10 to 18 years in this study compared with women aged 15 to 25 years from a separate study [23], an age range for which efficacy for the prevention of

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

Abstract

Purpose

Methods

Results

Conclusions

Section snippets

Study participants and ethics

Results

Discussion

Vaccine

J Adolesc Health

J Adolesc Health

BJOG

Lancet

Lancet

J Adolesc Health

Lancet

Vaccine

Type-specific persistence of human papillomavirus DNA before the development of invasive cervical cancer

N Engl J Med

Prospective seroepidemiologic study of human papillomavirus infection as a risk factor for invasive cervical cancer

J Natl Cancer Inst

Serologically diagnosed infection with human papillomavirus type 16 and risk for subsequent development of cervical carcinoma: nested case–control study

BMJ

Human papillomavirus as a risk factor for squamous-cell carcinoma of the head and neck cancer

N Engl J Med

Human papillomavirus infection as a risk factor for anal and perianal cancer in a prospective study

Br J Cancer

Human papillomavirus is a necessary cause of invasive cervical cancer worldwide

J Pathol

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