Trial reportVaccine2014
Efficacy of the HPV-16/18 vaccine: final according to protocol results from the blinded phase of the randomized Costa Rica HPV-16/18 vaccine trial.
Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00128661 (A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia), which is not on this map. Cited by 61 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.
Who cites it
61 citing papers in PubMed, 5 syntheses or guidelines pooled it, 132 citations in OpenAlex.
- Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Comprehensive evaluation of prophylactic HPV vaccines: a systematic review and meta-analysis of efficacy, safety, and immunogenicity in males and females.Frontiers in immunology · 2025Pooled it
- Barriers and facilitators of HPV vaccination in sub-saharan Africa: a systematic review.BMC public health · 2023Pooled it
- The effectiveness of vaccination to prevent the papillomavirus infection: a systematic review and meta-analysis.Epidemiology and infection · 2019Pooled it
- Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.The Cochrane database of systematic reviews · 2018Pooled it
- Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial.The Lancet. Oncology · 2020Trial
- Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine, for anogenital warts: the HIPvac factorial RCT.Health technology assessment (Winchester, England) · 2020Trial
- Cervicovaginal microbiome and natural history of HPV in a longitudinal study.PLoS pathogens · 2020Trial
- Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial.Cancer medicine · 2019Trial
- A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years.Human vaccines & immunotherapeutics · 2019Trial
- Efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine in Chinese women aged 18-25 years: event-triggered analysis of a randomized controlled trial.Cancer medicine · 2017Trial
- Cross-protection of the Bivalent Human Papillomavirus (HPV) Vaccine Against Variants of Genetically Related High-Risk HPV Infections.The Journal of infectious diseases · 2016Trial
- Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection.Journal of the National Cancer Institute · 2016Trial
- Trial
- Development of HPV 35 serology assays for assessment of immune responses to HPV 35 after infection and vaccination.Human vaccines & immunotherapeutics · 2026Article
- Projections of human papillomavirus (HPV) vaccination impact on non-cervical cancer outcomes among women in 117 low- and middle-income countries: a modelling study.BMJ global health · 2026Article
- Validation of TypeSeq2, a Next-Generation-Based Sequencing Assay for the Detection of 46 Human Papillomavirus Genotypes, at the US National Cancer Institute and Costa Rica Laboratories.The Journal of infectious diseases · 2025Article
- Article
- Human Papillomavirus: An Old New History.Pathogens (Basel, Switzerland) · 2025Review
- The indirect effect of the bivalent human papillomavirus vaccination program: an observational cohort study.BMC medicine · 2025Observational
1 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
Abstract
backgroundA community-based randomized trial was conducted in Costa Rica to evaluate the HPV-16/18 AS04-adjuvanted vaccine (NCT00128661). The primary objective was to evaluate efficacy of the vaccine to prevent cervical intraepithelial neoplasia 2 or more severe disease (CIN2+) associated with incident HPV-16/18 cervical infections. Secondary objectives were to evaluate efficacy against CIN2+ associated with incident cervical infection by any oncogenic HPVs and to evaluate duration of protection against incident cervical infection with HPV-16/18. Vaccine safety and immunogenicity over the 4-year follow-up were also evaluated.
methodsWe randomized (3727 HPV arm; 3739 control arm), vaccinated (HPV-16/18 or Hepatitis A) and followed (median 53.8 months) 7466 healthy women aged 18-25 years. 5312 women (2635 HPV arm; 2677 control arm) were included in the according to protocol analysis for efficacy. The full cohort was evaluated for safety. Immunogenicity was considered on a subset of 354 (HPV-16) and 379 (HPV-18) women. HPV type was assessed by PCR on cervical specimens. Immunogenicity was assessed using ELISA and inhibition enzyme immunoassays. Disease outcomes were histologically confirmed. Vaccine efficacy and 95% confidence intervals (95%CI) were computed.
resultsVaccine efficacy was 89.8% (95% CI: 39.5-99.5; N=11 events total) against HPV-16/18 associated CIN2+, 59.9% (95% CI: 20.7-80.8; N=39 events total) against CIN2+ associated with non-HPV-16/18 oncogenic HPVs and 61.4% (95% CI: 29.5-79.8; N=51 events total) against CIN2+ irrespective of HPV type. The vaccine had an acceptable safety profile and induced robust and long-lasting antibody responses.
conclusionsOur findings confirm the high efficacy and immunogenicity of the HPV-16/18 vaccine against incident HPV infections and cervical disease associated with HPV-16/18 and other oncogenic HPV types. These results will serve as a benchmark to which we can compare future findings from the ongoing extended follow-up of participants in the Costa Rica trial.
trial registrationRegistered with clinicaltrials.gov: NCT00128661.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.