ArticleVaccine2022
Rationale and design of a double-blind randomized non-inferiority clinical trial to evaluate one or two doses of vaccine against human papillomavirus including an epidemiologic survey to estimate vaccine efficacy: The Costa Rica ESCUDDO trial.
Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03180034 (A Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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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 Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus: the ESCUDDO Study ("Estudio de Comparacion de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 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
- Human papillomavirus (HPV) type 16 and type 18 antibody concentrations after a single dose of bivalent HPV vaccine in girls aged 9-14 years compared with three doses of quadrivalent HPV vaccine in women aged 18-25 years in Costa Rica (PRIMAVERA): a non-randomised, open-label, immunobridging, non-inferiority trial.The Lancet. Infectious diseases · 2025Trial
- HPV16/18 antibodies 16-years after single dose of bivalent HPV vaccination: Costa Rica HPV vaccine trial.Journal of the National Cancer Institute. Monographs · 2024Trial
- Trial
- Challenges and possible solutions towards reaching global cervical cancer elimination.EClinicalMedicine · 2026Review
- Real-world Impact of HPV Vaccination on CIN2+ Reduction: A Meta-analysis of Observational Studies Assessing Variation by Age, Coverage, and Vaccine Type.Open forum infectious diseases · 2026Review
- Review
- Single-dose HPV vaccination in the United States - a multi-modeling analysis.Lancet regional health. Americas · 2026Article
- Plasmablast, memory B cell and T follicular helper cell responses after human papillomavirus vaccination: effect of dose number and age.NPJ vaccines · 2026Article
- Immune Responses to Human Papillomavirus After Infection and Vaccination.Current topics in microbiology and immunology · 2026Review
- The Political Determinants of Oral Health Inequalities: Lessons in Policy Development and Implementation From Six Case Studies.Community dentistry and oral epidemiology · 2025Review
- Barriers in the prevention and early detection of human papillomavirus in Latin America.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Article
- Revolutionizing Nanovaccines: A New Era of Immunization.Vaccines · 2025Review
- Human papillomavirus prophylactic vaccines: update on new vaccine development and implications for single-dose policy.Journal of the National Cancer Institute. Monographs · 2024Review
- Single-dose human papillomavirus vaccination: an update.Journal of the National Cancer Institute. Monographs · 2024Article
- Review
- Efficacy, effectiveness and immunogenicity of reduced HPV vaccination schedules: A review of available evidence.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2024Article
- Can prophylactic HPV vaccination reduce the recurrence of cervical lesions after surgery? Review and prospect.Infectious agents and cancer · 2023Review
- Follow-up of humoral immune response after HPV vaccination using first-void urine: A longitudinal cohort study.Journal of medical virology · 2023Article
- Global impact and cost-effectiveness of one-dose versus two-dose human papillomavirus vaccination schedules: a comparative modelling analysis.BMC medicine · 2023Article
Corrections and comments
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Authors and funding
31 authors at 6 institutions in 2 countries.
Funding
Abstract
HPV vaccination of adolescent girls is the most effective measure to prevent cervical cancer. The World Health Organization recommends that adolescent girls receive two doses of vaccine but only a small proportion of girls from regions with the highest disease burden are vaccinated because of cost and logistical considerations. Our Costa Rica HPV Vaccine trial suggested that one dose of the bivalent HPV vaccine provides robust and lasting protection against persistent HPV infections for over a decade. Data from a post-licensure trial of the quadrivalent vaccine in India also suggested that a single dose may be effective in reducing cervical cancer risk. To formally compare one versus two doses of the bivalent and nonavalent HPV vaccines, we implemented a large, randomized, double-blind trial to investigate the non-inferiority of one compared to two vaccine doses in the prevention of new HPV16/18 infections that persist 6 or more months. Bivalent and nonavalent vaccines will be evaluated separately. The trial enrolled and randomized (1:1:1:1 to 1- and 2-dose arms of the bivalent and nonavalent vaccines) 20,330 girls 12 to 16 years old residing in Costa Rica. Trial participants are followed every 6 months for up to 5 years. We also aim to estimate vaccine efficacy by comparing the rates of 6 month persistent infection in unvaccinated women with the rates in the follow-up visits of trial participants. We included one survey of unvaccinated women at the start of the study (N = 4452) and will include another survey concomitant with follow up visits of trial participants at year 4.5 (planned N = 3000). Survey participants attend two visits 6 months appart. Herein, we present the rationale, design, and enrolled study population of the ESCUDDO trial. ClinicalTrials.gov Identifier: NCT03180034.
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Registered trials
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.