Dataset Information

Efficacy of single-dose HPV vaccination among young African women.

ABSTRACT:

Background

Single-dose HPV vaccination, if efficacious, would be tremendously advantageous; simplifying implementation and decreasing costs.

Methods

We performed a randomized, multi-center, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination compared to meningococcal vaccination among Kenyan women aged 15-20 years. Enrollment and six monthly cervical swabs and a month three vaginal swab were tested for HPV DNA. Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who tested HPV antibody negative at enrollment and HPV DNA negative at enrollment and month three. The primary outcome was incident persistent vaccine-type HPV infection by month 18.

Results

Between December 2018 and June 2021, 2,275 women were randomly assigned and followed; 758 received the nonavalent HPV vaccine, 760 the bivalent HPV vaccine, and 757 the meningococcal vaccine; retention was 98%. Thirty-eight incident persistent infections were detected in the HPV 16/18 mITT cohort: one each among participants assigned to the bivalent and nonavalent groups and 36 among those assigned to the meningococcal group; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001). Thirty-three incident persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: four in the nonavalent group and 29 in the meningococcal group; nonavalent VE for HPV 16/18/31/33/45/52/58 was 88.9% (95%CI 68.5-96.1%, p<0.0001). The rate of SAEs was 4.5-5.2% by group.

Conclusions

Over the 18 month time-frame we studied, single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens.

SUBMITTER: Barnabas RV

PROVIDER: S-EPMC9172784 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Efficacy of single-dose HPV vaccination among young African women.

Barnabas Ruanne V RV Brown Elizabeth R ER Onono Maricianah A MA Bukusi Elizabeth A EA Njoroge Betty B Winer Rachel L RL Galloway Denise A DA Pinder Leeya F LF Donnell Deborah D Wakhungu Imelda I Congo Ouma O Biwott Charlene C Kimanthi Syovata S Oluoch Linda L Heller Kate B KB Leingang Hannah H Morrison Susan S Rechkina Elena E Cherne Stephen S Schaafsma Torin T TT McClelland R Scott RS Celum Connie C Baeten Jared M JM Mugo Nelly N

NEJM evidence 20220411 5

BACKGROUND: Single-dose human papillomavirus (HPV) vaccination, if efficacious, would be tremendously advantageous, simplifying implementation and decreasing costs. METHODS: We performed a randomized, multicenter, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11 infection) or bivalent (HPV 16/18 infection) HPV vaccination compared with meningococcal vaccination among Kenyan women 15 to 20 years of age. Enrollment and 6-monthly cervical swabs and a month 3 v ...[more]

PMID: 35693874

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Project description:BackgroundHPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule.MethodsWe are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15-20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models.DiscussionThis study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery.Trial registrationClinicalTrials.gov NCT03675256 . Registered on September 18, 2018.

Project description:BackgroundGlobally, cervical cancer is an increasing public health issue, and vaccination against HPV has proven to be an effective strategy to reduce this neoplasia. The purpose of this study was to assess the effectiveness of the quadrivalent vaccine in reducing the prevalence and incidence of HPV infection in women, aged 18 to 24 years old, in the cities of Ouro Preto and Mariana, Minas Gerais, Brazil.MethodsA concurrent cohort study was performed, with an initial follow-up of 12 to 18 months. The selected young women were interviewed and divided into two groups: vaccinated and unvaccinated. Participants underwent a Pap smear and cervical sample collection for HPV detection, genotyping performed by PCR-RFLP, type-specific PCR, and using the PapilloCheck®. The prevalence of HPV infection was analyzed using the compare proportions test. Poisson and Cox multivariate regression models were used to estimate vaccine effectiveness.ResultsThere was no significant difference in the overall prevalence of HPV infection between vaccinated and unvaccinated groups (23.6% vs. 18.7%; p = 0.364). However, the prevalence of infection by HPV 6/11, 16 and 18 types in vaccinated young women (1.1%) was lower than in unvaccinated ones (7.5%; p = 0.030). Regarding non-vaccine types, a higher prevalence was identified among vaccinated women (22.5% vs. 11.2%; p = 0.018). The overall incidence of HPV infection was 15.75/100 young women/year in non-immunized women compared to 9.12/100 young women/year among those immunized. The effectiveness of the vaccine was 64.0%, regardless of the viral type, and no vaccinated woman was detected with the specific vaccine HPV-type in follow-up. HPV33/45, related to cross-protection, were detected in 12.3% of vaccinated women and 1.2% of unvaccinated ones (p < 0.001) at baseline. These viral types were identified at follow-up in 2.03/100 young women/year of vaccinated participants and 4.24/100 young women/year of unvaccinated ones.ConclusionsThe results showed that the quadrivalent HPV vaccine was effective in reducing the prevalence of vaccine-type HPV and the incidence of infection by any HPV type. Public health policies must encourage vaccination to prevent HPV infection. However, surveillance of HPV infection should be continued to assess the prevalence of different genotypes and the impact of the vaccination program.

Project description:BackgroundIn 2008/9, Fiji vaccinated >30,000 girls aged 9-12 years with the quadrivalent human papillomavirus (4vHPV) vaccine coverage for at least one dose was >60% (one dose only was 14%, two dose only was 13%, three doses was 35%). We calculated vaccine effectiveness (VE) of one, two and three doses of 4vHPV against oncogenic HPV genotypes 16/18, eight years following vaccination.MethodsA retrospective cohort study was undertaken (2015-2019) in pregnant women ≤23 years old, eligible to receive 4vHPV in 2008/9, with confirmed vaccination status. The study was restricted to pregnant women due to the cultural sensitivity of asking about sexual behavior in Fiji. For each participant a clinician collected a questionnaire, vaginal swab and genital warts examination, a median eight (range 6-11) years post vaccination. HPV DNA was detected by molecular methods. Adjusted VE (aVE) against the detection of vaccine HPV genotypes (16/18), the comparison group of non-vaccine genotypes (31/33/35/39/45/51/52/56/58/59/66/68), and genital warts were calculated. Covariates included in the adjusted model were: age, ethnicity and smoking, according to univariate association with any HPV detection.FindingsAmong 822 participants the prevalence of HPV 16/18 in the unvaccinated, one, two and three-dose groups were 13.3% (50/376), 2.5% (4/158), 0% (0/99) and 1.6% (3/189), respectively; and for the non-vaccine high-risk genotypes, the detection rate was similar across dosage groups (33.2%-40.4%, p = 0.321). The aVE against HPV 16/18 for one, two and three doses were 81% (95% CI; 48-93%), 100% (95% CI; 100-100%), and 89% (95% CI; 64-96%), respectively. Prevalence of HPV 16/18 was lower among women with longer time since vaccination.InterpretationsA single dose 4vHPV vaccine is highly effective against HPV genotypes 16 and 18 eight years following vaccination. Our results provide the longest duration of protection for reduced dose 4vHPV schedule in a low- or middle-income country in the Western Pacific region.FundingThis study was supported by the Bill & Melinda Gates Foundation and the Department of Foreign Affairs and Trade of the Australian Government and Fiji Health Sector Support Program (FHSSP). FHSSP is implemented by Abt JTA on behalf of the Australian Government.

Project description:IntroductionHuman papillomavirus (HPV) is the most common sexually transmitted infection (STI) worldwide. Despite recommendations for HPV vaccination of young women from health authorities, parental concerns were raised whether vaccination could induce unsafe sexual behaviour in young women. Therefore, the primary aim of this study was to investigate if HPV vaccination in healthcare seeking adult women in Luxembourg was associated with unsafe sexual behaviour.MethodsSeven hundred twenty-nine women (mean age = 22.5; range 18-43 years) were recruited either at Luxembourg family planning centres or at private gynaecology practices. All participants completed a questionnaire on vaccination status and sexual behaviour. Poisson and logistic regressions were used to study the association between sexual behaviour and vaccination status (N = 538). Both models were restricted to women younger than 26 years, since the first cohort being vaccinated would be 25 years old at the time of sampling. Assortativity of sexual mixing by age was also assessed for further transmission modelling for women <30 years reporting age of last/current sexual partner (N = 649). Women older than 29 years were excluded from the assortativity analysis due to restricted sample size.ResultsIn total, 386/538 (71.8%) of participants reported receiving HPV vaccine. Vaccination uptake significantly varied by nationality and was higher in Portuguese 112/142 (78.9%) and in Luxembourgish 224/313(71.6%) residents, and lower in residents of other nationalities 50/83 (60.2%) (p = 0.011). HPV vaccination was not associated with unsafe sexual behaviour such as shorter relationship duration with current or last sexual partner (odds ratio (OR) = 1.05, 95% CI [0.94-1.16]), younger age of sexual debut (OR = 1.00, 95% CI [0.88-1.14]), increased number of lifetime sexual partners (OR = 0.95, 95% CI [0.87-1.03), higher age difference with sexual partner (OR = 1.01, 95% CI [0.95-1.08]), condom use (OR = 0.97, 95% CI [0.60-1.56]), nor with other factors like smoking (OR = 0.73, 95% CI [0.47-1.15]) and nationality. HPV vaccination was only associated with younger age (OR = 0.84, 95% CI [0.75-0.94]). Relationship duration, age of sexual debut, age difference with sexual partner, smoking, age and non-Portuguese foreign nationality were predictors of number of lifetime sexual partners. Assortativity analysis revealed that young women chose sexual partners who were 2.3 years older on average.ConclusionsOur study found no association between unsafe sexual behaviour and HPV vaccination.

Project description:BackgroundWhile prophylactic human papilloma virus (HPV) vaccination is considered effective in young girls, it is unclear whether a catch-up vaccination of older girls would be beneficial. We, therefore, aimed to examine the potential health impact of a HPV catch-up vaccination of girls who were too old at the time of vaccine introduction, hence aged 16 and older.MethodsWe systematically searched the literature for randomized clinical trials (RCTs) that examined the effect of HPV vaccines on overall mortality, cancer mortality and incidence, high-grade cervical intraepithelial neoplasia grade 2 and higher (CIN2+), vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VaIN) grade 2 and higher lesions (VIN2+ and VaIN2+, respectively) genital warts (condyloma). We considered all lesions and those associated with HPV type(s) included in the vaccines. RCTs reporting on serious adverse events were also eligible. Selected publications were assessed for potential risk of bias, and we ascertained the overall quality of the evidence for each outcome using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Meta-analyses were performed, assuming both random and fixed effects, to estimate risk ratios (RR) and corresponding 95% confidence intervals (CI), using intention-to-treat and per-protocol populations.ResultsWe included 46 publications reporting on 13 RCTs. Most of the RCTs had a maximum follow-up period of four years. We identified no RCT reporting on the effect of HPV catch vaccination on overall and cancer related mortality, and on cervical cancer incidence. We found a borderline protective effect of a HPV catch-up vaccination on all CIN2+, with a pooled RR of 0.80 (95% CI: 0.62-1.02) for a follow-up period of 4 years. A HPV catch-up vaccination was associated with a reduction in VIN2+ and VaIN2+ lesions, and condyloma. No difference in risk of serious adverse events was seen in vaccinated participants versus unvaccinated women (pooled RR of 0.99 (0.91-1.08)).ConclusionsThis systematic review indicates that a HPV catch-up vaccination could be beneficial, however the long-term effect of such a vaccination, and its effect on cervical cancer incidence and mortality is still unclear.

Dataset Information

Efficacy of single-dose HPV vaccination among young African women.

Background

Methods

Results

Conclusions

Publications

Efficacy of single-dose HPV vaccination among young African women.

Similar Datasets

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