Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa
“…Therefore, it will be important to further evaluate the immunogenicity of the 9vHPV vaccine in these regions, especially given the prevalence of HIV infection or other co-infections and malnutrition in these regions which may impact immune response to the vaccine. Of note, studies of the qHPV vaccine in sub-Saharan Africa, India, and Vietnam, and a study in HIV-infected children demonstrated robust immunogenicity in these populations [36] , [37] , [38] , [39] . Given that the 9vHPV vaccine and qHPV vaccine have comparable immunogenicity profiles [10] , [11] , [12] , similar results are expected with the 9vHPV vaccine.…”
BackgroundThe immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9–15 years of age and young women 16–26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.MethodsImmunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.ResultsGMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.Conclusions9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.
“…Therefore, it will be important to further evaluate the immunogenicity of the 9vHPV vaccine in these regions, especially given the prevalence of HIV infection or other co-infections and malnutrition in these regions which may impact immune response to the vaccine. Of note, studies of the qHPV vaccine in sub-Saharan Africa, India, and Vietnam, and a study in HIV-infected children demonstrated robust immunogenicity in these populations [36] , [37] , [38] , [39] . Given that the 9vHPV vaccine and qHPV vaccine have comparable immunogenicity profiles [10] , [11] , [12] , similar results are expected with the 9vHPV vaccine.…”
BackgroundThe immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9–15 years of age and young women 16–26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.MethodsImmunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.ResultsGMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.Conclusions9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.
Our purpose was to determine the effectiveness and harms of vaccination in patients with any sexual history to prevent the prevalence of papillomavirus infection. A search strategy was conducted in the MEDLINE, CENTRAL, EMBASE and LILACS databases. Searches were also conducted in other databases and unpublished literature. The risk of bias was evaluated with the Cochrane Collaboration's tool. Analysis of fixed effects was conducted. The primary outcome was the infection by any and each human papillomavirus (HPV) genotype, serious adverse effects and short-term adverse effects. The measure of the effect was the risk difference (RD) with a 95% confidence interval (CI). The planned interventions were bivalent vaccine/tetravalent/nonavalent vs. placebo/no intervention/other vaccines. We included 29 studies described in 35 publications. Bivalent HPV vaccine offers protection against HPV16 (RD −0.05, 95% CI −0.098 to −0.0032), HPV18 (RD −0.03, 95% CI −0.062 to −0.0004) and HPV16/18 genotypes (RD of −0.1, 95% CI −0.16 to −0.04). On the other side, tetravalent HPV vaccine offered protection against HPV6 (RD of −0.0500, 95% CI −0.0963 to −0.0230), HPV11 (RD −0.0198, 95% CI −0.0310 to −0.0085). Also, against HPV16 (RD of −0.0608, 95% CI −0.1126 to −0.0091) and HPV18 (RD of −0.0200, 95% CI −0.0408 to −0.0123). There was a reduction in the prevalence of HPV16, 18 and 16/18 genotypes when applying the bivalent vaccine, with no increase in adverse effects. Regarding the tetravalent vaccine, we found a reduction in the prevalence of HPV6, 11, 16 and 18 genotypes, with no increase in adverse effects.
“…One study [ 42 ] had insufficient information on discontinued data. The risks of bias due to inadequate random sequence generation and inadequate allocation concealment were judged to be ‘unclear’ in seven studies [ 26 , 29 – 31 , 35 , 38 ] and four studies [ 26 , 33 , 38 ], respectively. Fig.…”
Section: Resultsmentioning
confidence: 99%
“… Solicited local symptoms We analyzed nine placebo-controlled studies (four 2vHPV vaccine [ 27 , 31 , 43 , 44 ] and five 4vHPV vaccine studies [ 30 , 38 , 39 , 42 , 46 ]) for the primary safety outcome. A meta-analysis showed a significantly higher incidence of any solicited local symptom in the pooled HPV vaccine (2vHPV and 4vHPV) group compared to the placebo group (overall RR: 1.20, 95% CI: 1.13 to 1.27) (Fig.…”
Section: Resultsmentioning
confidence: 99%
“…Three of the five studies [ 34 , 40 , 41 ] reported that the symptoms lasted no longer than 4–5 days in both groups, and the remaining two studies did not report the duration of symptoms [ 27 , 37 ]. Only one study tested 4vHPV [ 38 ] reported grade 3 pain, and there was no significant difference in the pain compared with the placebo arm (RR: 0.50 [0.06 to 3.96]). Solicited systemic symptoms We analyzed nine placebo-controlled studies (three 2vHPV vaccine [ 31 , 43 , 44 ] and six 4vHPV vaccine studies [ 30 , 32 , 38 , 39 , 42 , 46 ]).…”
BackgroundHuman papillomavirus (HPV) vaccines have been shown to be effective for the eradication of HPV and prevention of cervical cancer. However, the number of women who receive HPV vaccinations has decreased over the last several years in Japan, due to concerns about adverse reactions associated with the vaccines. We evaluated the safety of three types of HPV vaccines separately in young women and the difference in the risk of adverse reactions between HPV and other vaccines by conducting a meta-analysis.MethodsPrimary literature was retrieved from MEDLINE, the Cochrane Central Register of Controlled Trials, and Japana Centra Revuo Medicina. Prospective controlled studies with participants consisting exclusively of healthy women who received bivalent, quadrivalent, or 9-valent HPV (2vHPV, 4vHPV or 9vHPV) vaccines were included. Primary safety outcome was the incidence of solicited local and systemic symptoms, and unsolicited symptoms. When two or more studies were found for the same analysis, a meta-analysis was applied.ResultsA total of 24 controlled studies from 22 articles were included in our study. Of the 24 studies, 16 were placebo-controlled and eight were active-controlled (different HPV vaccine or hepatitis vaccine). Average ages of the participants ranged from 12 to 37 years. A significantly higher incidence of solicited local symptoms was observed following injection of HPV vaccines (2vHPV and 4vHPV) compared to placebo, but there was no difference between HPV vaccines [risk ratio (RR) for 2vHPV: 1.25, 95% confidence interval (CI): 1.09 to 1.43, RR for 4vHPV: 1.16, 95% CI: 1.11 to 1.20]. The incidence of solicited systemic symptoms was not different between HPV vaccines and placebo (RR: 1.04, 95% CI: 0.99 to 1.09). The incidence of unsolicited symptoms was significantly higher for 2vHPV vaccine compared to placebo (RR: 1.28, 95% CI: 1.01 to 1.63), but was not significantly different between 2vHPV and hepatitis B vaccines.ConclusionsHPV vaccines had significantly higher risk of any injection site symptom compared to placebo or other vaccines (hepatitis A and B vaccines), and the incidence of solicited local symptoms was no difference between 2vHPV vaccination and 4vHPV vaccination. However, the most adverse reactions were transient.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
