Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study
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BACKGROUND: A randomised trial designed to compare three and two doses of quadrivalent human papillomavirus (HPV) vaccine in adolescent girls in India was converted to a cohort study after suspension of HPV vaccination in trials by the Indian Government. In this Article, the revised aim of the cohort study was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years post vaccination. METHODS: In the randomised trial, unmarried girls aged 10-18 years were recruited from nine centres across India and randomly assigned to either two doses or three doses of the quadrivalent HPV vaccine (Gardasil [Merck Sharp & Dohme, Whitehouse Station, NJ, USA]; 0·5 mL administered intramuscularly). After suspension of recruitment and vaccination, the study became a longitudinal, prospective cohort study by default, and participants were allocated to four cohorts on the basis of the number vaccine doses received per protocol: the two-dose cohort (received vaccine on days 1 and 180 or later), three-dose cohort (days 1, 60, and 180 or later), two-dose default cohort (days 1 and 60 or later), and the single-dose default cohort. Participants were followed up yearly. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Married participants were screened for cervical cancer as they reached 25 years of age. Unvaccinated women age-matched to the married vaccinated participants were recruited to serve as controls. Vaccine efficacy against persistent HPV 16 and 18 infections (the primary endpoint) was analysed for single-dose recipients and compared with that in two-dose and three-dose recipients after adjusting for imbalance in the distribution of potential confounders between the unvaccinated and vaccinated cohorts. This trial is registered with ISRCTN, ISRCTN98283094, and ClinicalTrials.gov, NCT00923702. FINDINGS: Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010 (date of vaccination suspension), and followed up over a median duration of 9·0 years (IQR 8·2-9·6). 4348 participants had three doses, 4980 had two doses (0 and 6 months), and 4949 had a single dose. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95·4% (95% CI 85·0-99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3-99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5-99·7) in three-dose recipients (1460 women assessed). INTERPRETATION: A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses. FUNDING: Bill & Melinda Gates Foundation.
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Single-dose HPV vaccination provides comparable or non-inferior efficacy against persistent HPV infection compared with multi-dose schedules, with lower but sustained antibody levels for at least 11 years after vaccination.
“Notably, the IARC India trial with a quadrivalent vaccine, and the Costa Rica Trial with a bivalent vaccine, have shown comparable efficacy between single-dose and multi-dose schedules, with sustained antibody levels for at least 11 years after vaccination.”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [11]
The Discussion reports that one dose of the quadrivalent vaccine had efficacy against persistent HPV 16/18 infection no different from two or three doses through 10 years. It also says single-dose antibody concentrations remained sustained for at least a decade, but does not establish the claimed 11-year duration or that those levels were lower than after multiple doses. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe IARC India HPV vaccine trial currently provides the best data on single-dose protection because of its long follow-up and near-random assignment of participants to different dose schedules.
“which currently provides the best data on single-dose protection because of its long follow-up and near-random assignment of participants to different dose schedules.10, 11”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [11]
Titles and abstracts of all retrieved records were independently screened by two reviewers using pre-defined inclusion and exclusion criteria.
“The titles and abstracts of all retrieved records were independently screened by two reviewers (KJ and RRD) using pre-defined inclusion and exclusion criteria on the Rayyan web-based systematic review platform8.”
From Barriers to HPV vaccination among adolescent girls in India: A scoping review (2026) · cites this paper as [8]
The Methods sections describe recruitment, HPV testing, and cervical cancer screening in a prospective cohort, not screening titles and abstracts of retrieved records. Searches for independent reviewer screening, inclusion and exclusion criteria, and Rayyan found no supporting passage in our copy. (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Basu, P., Malvi, S. G., Joshi, S., Bhatla, N., Muwonge, R., Lucas, E., Verma, Y., Esmy, P. O., Poli, U. R. R., Shah, A., Zomawia, E., Pimple, S., Jayant, K., Hingmire, S., Chiwate, A., Divate, U., Vashist, S., Mishra, G., Jadhav, R., Siddiqi, M., Sankaran, S., Prabhu, P. R., Kannan, T. P. R. A., Varghese, R., Shastri, S. S., Anantharaman, D., Gheit, T., Tommasino, M., Sauvaget, C., Pillai, M. R., & Sankaranarayanan, R.
- Affiliations
- Centre international de recherche sur le cancer (FR)
- Nargis Dutt Memorial Cancer Hospital (IN)
- Jehangir Hospital (IN)
- All India Institute of Medical Sciences (IN)
- Sikkim Manipal University (IN)
- Public Health Foundation of India (IN)
- Gujarat Cancer & Research Institute (IN)
- Homi Bhabha National Institute (IN)
- Cancer Foundation of India (IN)
- Rajiv Gandhi Centre for Biotechnology (IN)
- Fred Hutch Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- RTI International (US)
- Corresponding author
- Basu, Partha
- ORCID
- Basu, Partha
- Bhatla, Neerja
- Muwonge, Richard
- Lucas, Eric
- Verma, Yogesh
- Poli, Usha Rani Reddy
- Shah, Anand
- Zomawia, Eric
- Pimple, Sharmila
- Divate, Uma
- Vashist, Shachi
- Mishra, Gauravi
- Siddiqi, Maqsood
- Prabhu, Priya Ramesh
- Varghese, Rintu
- Shastri, Surendra S
- Anantharaman, Devasena
- Gheit, Tarik
- Tommasino, Massimo
- Sauvaget, Catherine
- Pillai, M Radhakrishna
- Sankaranarayanan, Rengaswamy
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2021-11
- Volume
- 22
- Issue
- 11
- Pages
- 1518-1529
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC8560643
- OpenAlex
- W3204615344
- Cited by
- 272
- References
- 29
- Citations by year
- 2026: 41 · 2025: 63 · 2024: 72 · 2023: 46 · 2022: 41 · 2021: 9
- FWCI
- 30.26
- Type
- journal article
- Language
- en
- Update notices
- erratum (2022-01-01)
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Oncology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline
- World Health Organization
- Centre International de Recherche sur le Cancer
- Seventh Framework Programme (FP7-HEALTH-2011-282562)
- Bill and Melinda Gates Foundation
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Surgery › Genital Health and Disease
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- human papillomavirus, HPV16, HPV 18, quadrivalent HPV vaccine, Gardasil, vaccine efficacy, persistent HPV infection, single-dose vaccination, two-dose vaccination, adolescent girls, cervical cancer prevention, cervical cancer screening, India, cervical cancer incidence
- MeSH terms
- Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Adolescent, Uterine Cervical Neoplasms, Cervix Uteri, Child, Female, Humans, India, Longitudinal Studies, Prospective Studies, Vaccination, Papillomavirus Infections, Human papillomavirus 18, Human papillomavirus 16
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