Evidence map›Paper›PMID 39529521›Full record

Trial reportJournal of the National Cancer Institute. Monographs2024

A prospective cohort study comparing efficacy of 1 dose of quadrivalent human papillomavirus vaccine to 2 and 3 doses at an average follow up of 12 years postvaccination.

Sylla G Malvi, Pulikkottil O Esmy, Richard Muwonge, Smita Joshi, Usha Rani Reddy Poli, Eric Lucas, Yogesh Verma, Pesona Grace Lucksom, Anand Shah, Bijal Patel and 19 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of the National Cancer Institute. Monographs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. FIGO position statement on the effectiveness and safety of the HPV vaccine.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Article
  14. Cancer of the cervix uteri: 2025 update.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Review
  15. Immunogenicity comparison of anThe Lancet regional health. Western Pacific · 2025
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Sylla G MalviTata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi, Solapur, India.
Pulikkottil O EsmyDepartment of Radiation Oncology, Christian Fellowship Community Health Centre, Dindigul, India.
Richard MuwongeEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.
Smita JoshiJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.
Usha Rani Reddy PoliPublic Health Foundation of India, Indian Institute of Public Health - Hyderabad, Hyderabad, India.
Eric LucasEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.
Yogesh VermaSikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Gangtok, Sikkim, India.
Pesona Grace LucksomSikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Gangtok, Sikkim, India.
Anand ShahGujarat Cancer & Research Institute, M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad, India.
Bijal PatelGujarat Cancer & Research Institute, M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad, India.
Eric ZomawiaCivil Hospital, Aizawl, Mizoram, India.
Sharmila PimpleDepartment of Preventive Oncology, Centre for Cancer Epidemiology, Homi Bhabha National Institute, Tata Memorial Centre, Mumbai, India.
Kasturi JayantTata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi, Solapur, India.
Sanjay HingmireTata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi, Solapur, India.
Aruna ChiwateTata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi, Solapur, India.
Uma DivateJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.
Shachi VashistDepartment of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
Gauravi MishraDepartment of Preventive Oncology, Centre for Cancer Epidemiology, Homi Bhabha National Institute, Tata Memorial Centre, Mumbai, India.
Radhika JadhavJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, India.
Maqsood SiddiqiCancer Foundation of India, Kolkata, West Bengal, India.
Catherine SauvagetEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.
Subha SankaranCancer Research Division, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
Thiraviam Pillai Rameshwari Ammal KannanCancer Research Division, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
Surendra S ShastriDepartment of Health Disparities Research, Division of Cancer Prevention and Population Sciences, University of Texas, Houston, TX, USA.
M Radhakrishna PillaiCancer Research Division, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
Devasena AnantharamanCancer Research Division, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
Neerja BhatlaDepartment of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
Rengaswamy SankaranarayananKarkinos Healthcare, Kerala Operations, Ernakulam, India.
Partha BasuEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.

Funding

European Commission Seventh Framework FP7-HEALTH-2011-282562Gates FoundationRajiv Gandhi Centre for BiotechnologyWorld Health Organization 001
6 · The paper itself

Abstract

backgroundWhile recommending a human papillomavirus (HPV) single-dose vaccination schedule in 2022, the World Health Organization highlighted the need for long-term follow-up studies to monitor waning of protection. We report on vaccine efficacy against HPV infections in 1-, 2-, and 3-dose schedules and protection against cervical precancers at a median follow-up of 12 years postvaccination.

methodsThis randomized multicenter study in India was originally designed to vaccinate unmarried girls aged 10-18 years with either 2 or 3 doses of quadrivalent HPV vaccine. A ministerial decree to halt vaccination in trials resulted in the creation of cohorts receiving different doses, including just a single dose. Cohorts were assessed for incident and persistent infections by genotyping cervical samples collected yearly for 4 consecutive years after participants were married. Cervical screening with an HPV test was initiated at age 25 years for married participants. Age- and site-matched unvaccinated married women were recruited to be compared with vaccinated cohorts. Vaccine efficacy was assessed using proportional incidence ratios.

resultsThe number of participants in the 1-, 2- (at 0 and 6 months), and 3-dose cohorts was 4949, 4980, and 4348, respectively. Of the recipients, 71%-82% in the different cohorts were eligible to provide samples for genotyping. Vaccine efficacy against persistent HPV 16 and 18 infection was 92.0% (95% confidence interval [CI] = 87.0% to 95.0%) in 3022 recipients of the single dose; and comparable with that observed in the 2-dose arm (94.8%, 95% CI = 90.0% to 97.3%) and the 3-dose arm (95.3%, 95% CI = 90.9% to 97.5%). No high-grade precancer associated with HPV 16 and 18 was detected among vaccinated participants compared with 8 precancers detected among the unvaccinated women.

conclusionThis observational cohort study has established that a single dose of HPV vaccine provides high protective efficacy against persistent HPV 16 and 18 infections and associated neoplasia 15 years postvaccination.

Indexed as

Papillomavirus InfectionsUterine Cervical NeoplasmsAdolescentAdultChildFemaleFollow-Up StudiesHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansImmunization ScheduleIndiaPapillomavirus VaccinesProspective StudiesVaccinationVaccine EfficacyYoung AdultHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus Vaccines

Identifiers

PMID39529521
PMCPMC11555276

What OpenQuestion holds

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Registered trials

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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.