Efficacy of the human papillomavirus (HPV)‐16/18 AS04‐adjuvanted vaccine in women aged 15–25 years with and without serological evidence of previous exposure to HPV‐16/18

Abstract

In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)‐16/18 AS04‐adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) was highly efficacious against HPV‐16/18 infections and precancerous lesions in women HPV‐16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV‐16/18 in the total vaccinated cohort including women who may have been exposed to HPV‐16/18 infection before vaccination. In women with no evidence of current or previous HPV‐16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3–92.6) against 6‐month persistent infection (PI), 91.9% (84.6–96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3–98.4) against CIN2+ [97.7% (91.1–99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV‐16/18 DNA negative but with serological evidence of previous HPV‐16/18 infection (seropositive), VE was 72.3% (53.0–84.5) against 6‐month PI, 67.2% (10.9–89.9) against CIN1+, and 68.8% (−28.3–95.0) against CIN2+ [88.5% (10.8–99.8) when using TAA]. In women with no evidence of current HPV‐16/18 infection (DNA negative), regardless of their baseline HPV‐16/18 serological status, VE was 88.7% (85.7–91.1) against 6‐month PI, 89.1% (81.6–94.0) against CIN1+ and 92.4% (84.0–97.0) against CIN2+ [97.0% (90.6–99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV‐16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV‐16/18 DNA or serological status at entry.

Long-term Immunogenicity and Safety of the HPV-16/18 AS04-adjuvanted Vaccine in 10- to 14-year-old Girls

“…In this population, the HPV-16/18 AS04-adjuvanted vaccine was shown to be highly efficacious in preventing HPV-16 and -18 persistent infections and associated precancerous cervical lesions, to confer protection during at least 6.4 years postvaccination in HPV-naive women, and to induce immune responses that lasted up to 9.4 years after vaccination. [13][14][15][16][17][18][19][20][21][22][23] Moreover, statistical models have predicted that anti-HPV-16 and -18 antibody levels induced by this vaccine in women aged 15-25 years would remain above those induced by natural infection for at least 20 years. 24 In preteen/adolescent girls aged 9-14 years, ie, the primary targeted population for organized vaccination programs, immune responses induced by the HPV-16/18 AS04-adjuvanted vaccine have been shown to be approximately 2-fold higher than in young adult women.…”

Vaccination against oncogenic human papillomavirus infection in HIV-infected populations: review of current status and future perspectives

“…15,38 However, prevalent infection by one HPV type included in the vaccines did not reduce the vaccine-induced protection against other HPV vaccine types. 39,40 In many countries, HPV vaccination programs primarily target preadolescents around 12 years of age (i.e. before most individuals' sexual debut).…”

Detection of Immunoglobulin IgA and IgG Against Human Papilloma Virus

“…In the context of vaccination, serological assays could be used to screen subjects for suitability and evaluate seroconversion in the vaccine. Moreover, the use of international standardization will guarantee a universal protocol (17,20,25,29,30).…”