Safety and Immunogenicity of Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine: A Randomized Trial in 10–25-Year-Old HIV-Seronegative African Girls and Young Women

Abstract

Background. Cervical cancer is a major public health problem for women in sub-Saharan Africa. Availability of a human papillomavirus (HPV) vaccine could have an important public health impact.Methods. In this phase IIIb, double-blind, randomized, placebo-controlled, multicenter trial (NCT00481767), healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10–14 or 15–25 years) and randomized (2:1) to receive either HPV-16/18 AS04-adjuvanted vaccine (n = 450) or placebo (n = 226) at 0, 1, and 6 months. The primary objective was to evaluate HPV-16/18 antibody responses at month 7. Seropositivity rates and corresponding geometric mean titers (GMTs) were measured by enzyme-linked immunosorbent assay.Results. In the according-to-protocol analysis at month 7, 100% of initially seronegative participants in the vaccine group were seropositive for both anti–HPV-16 and anti–HPV-18 antibodies (n = 130 and n = 128 for 10–14-year-olds, respectively; n = 190 and n = 212 for 15–25-year-olds). GMTs for HPV-16 and HPV-18 were higher in 10–14-year-olds (18 423 [95% confidence interval, 16 185–20 970] and 6487 [5590–7529] enzyme-linked immunosorbent assay units (EU)/mL, respectively) than in 15–25-year-olds (10 683 [9567–11 930] and 3743 [3400–4120] EU/mL, respectively). Seropositivity was maintained at month 12. No participant withdrew owing to adverse events. No vaccine-related serious adverse events were reported.Conclusions. The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.

Immunogenicity to the bivalent HPV-16/18 vaccine among adolescent African students exposed to helminths and malaria

“…We found no negative effect on the immunogenicity to the bivalent HPV-16/18 vaccine among students who had evidence of exposure to malaria or helminths. This finding is similar to emerging evidence from a study of another African population in Tanzania [16]. In agreement with our study, the Tanzania study found no negative effect on the immune response to the bivalent HPV vaccine as well.…”

Immunogenicity and safety of human papillomavirus (HPV) vaccination in Asian populations from six countries: a meta-analysis

“…In addition, the aggregate value of the GMT also demonstrated that HPV vaccines were highly immunogenic in terms of HPV-specific antibody stimulation. The current findings on the vaccines' immunogenicity are perfectly comparable to the results of numerous studies conducted in western countries, including the US, European countries, Australia (41-43), or other regions such as Latin America (40) and Africa (44). The studies evaluated in this meta-analysis involved similar research methods compared with earlier studies, including sample characteristics, vaccine types, dosing, and administration schedules.…”

Identifying and Overcoming Perceived Barriers of Providers towards HPV Vaccination: A Literature Review

“…Based on the evidence of clinical trials, HPV vaccination has been shown to be safe [10,33,34]. Among the 67 million doses of the quadrivalent vaccine distributed from 2006 to 2014 and 719,000 doses of the bivalent vaccine distributed from 2009 through 2014 in the US, 25,176 adverse events were reported [10].…”

“…Additional adverse events, albeit rare, have included hospitalizations, pyrexia, allergic reaction, and asthmatic crisis [35]. Studies have found no association of quadrivalent or bivalent vaccination with Journal of Vaccines 5 increased risk for thromboembolic events, clotting dysfunction, anaphylaxis, hospitalizations, or emergency room visits related to autoimmune conditions, Guillain-Barre syndrome, or seizures [34,37,38].…”