Cited by 272Cervical Cancer and HPV ResearchGenital Health and DiseaseReproductive tract infections research

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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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Basu, Partha, Malvi, Sylla G, Joshi, Smita, Bhatla, Neerja, Muwonge, Richard, Lucas, Eric, Verma, Yogesh, Esmy, Pulikkottil O, Poli, Usha Rani Reddy, Shah, Anand, Zomawia, Eric, Pimple, Sharmila, Jayant, Kasturi, Hingmire, Sanjay, Chiwate, Aruna, Divate, Uma, Vashist, Shachi, Mishra, Gauravi, Jadhav, Radhika, Siddiqi, Maqsood, Sankaran, Subha, Prabhu, Priya Ramesh, Kannan, Thiraviam Pillai Rameshwari Ammal, Varghese, Rintu, Shastri, Surendra S, Anantharaman, Devasena, Gheit, Tarik, Tommasino, Massimo, Sauvaget, Catherine, Pillai, M Radhakrishna, Sankaranarayanan, Rengaswamy·2021·The Lancet Oncology

DOI 10.1016/s1470-2045(21)00453-8PMC PMC8560643

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Abstract

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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Figure 1 Study flow chart HC II=Hybrid Capture II. HPV=human papillomavirus.CC BY · PubMed Central

Figure 2 Incidence of HPV 16 and 18 (A), and HPV 31, 33, and 45 (B) HPV=human papillomavirus.CC BY · PubMed Central

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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)
DOI: 10.1016/s1470-2045(21)00453-8
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: cc-by
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
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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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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