Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
3 other identifiers
interventional
22,729
1 country
8
Brief Summary
The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the country in April 2010 due to reasons not related to this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2009
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedResults Posted
Study results publicly available
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedSeptember 28, 2023
September 1, 2023
7.3 years
June 17, 2009
March 12, 2021
September 27, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points
Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA.
Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48
Frequency of Persistent HPV 16/18/6/11 Infection.
The first cervical cell samples were collected from women 18 months after married or 6 months after the first delivery. After that, 3 extra annual collections were obtained. The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
From date of marriage through to 7 years of follow-up
Frequency of HPV 16/18-associated Precancerous Lesions and Cancer.
Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of HPV 16 and/or HPV 18 by PCR in the same biopsy tissue sample.
Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen
Secondary Outcomes (2)
Frequency of Infection by Other Non-targeted High-risk HPV Types.
Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen
Frequency of Cervical Neoplasia Associated With Non-included HPV Types.
15 years from the base-line date
Study Arms (5)
3-dose
ACTIVE COMPARATORThe participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
2-dose
EXPERIMENTALThe participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
2 doses by default
EXPERIMENTALThe participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Single-dose
EXPERIMENTALThe participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Unvaccinated
NO INTERVENTIONA cohort of unvaccinated women
Interventions
The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
Eligibility Criteria
You may qualify if:
- Apparently healthy, ambulant girls aged 10 - 18 years
- Unmarried girls
- Girls with intact uterus
- Resident in the villages chosen for the study
You may not qualify if:
- Girls with any severe and/or debilitating illness
- Past history of allergy to any medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Partha Basulead
- All India Institute of Medical Sciencescollaborator
- Cancer Foundation of Indiacollaborator
- Christian Fellowship Community Health Centrecollaborator
- German Cancer Research Centercollaborator
- Gujarat Cancer & Research Institutecollaborator
- Jehangir Clinical Development Centrecollaborator
- MNJ Institute of Oncology and Regional Cancer Centercollaborator
- Rajiv Gandhi Centre for Biotechnologycollaborator
- Nargis Datta Memorial Cancer Hospitalcollaborator
- Tata Memorial Centrecollaborator
Study Sites (8)
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Andhra Pradesh, 500004, India
Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, Gujarat, 380 016, India
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital
Barshi, Maharashtra, 413 401, India
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Mumbai, Maharashtra, 400 012, India
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.
Pune, Maharashtra, 411 001, India
Christian Fellowship Community Health Centre
Ambilikkai, Tamil Nadu, 624612, India
Cancer Foundation of India
Kolkata, West Bengal, 700031, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Related Publications (7)
Basu P, Malvi SG, Joshi S, Bhatla N, Muwonge R, Lucas E, Verma Y, Esmy PO, Poli URR, 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 PR, Kannan TPRA, Varghese R, Shastri SS, Anantharaman D, Gheit T, Tommasino M, Sauvaget C, Pillai MR, Sankaranarayanan R. 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. Lancet Oncol. 2021 Nov;22(11):1518-1529. doi: 10.1016/S1470-2045(21)00453-8. Epub 2021 Oct 8.
PMID: 34634254BACKGROUNDSankaranarayanan R, Prabhu PR, Pawlita M, Gheit T, Bhatla N, Muwonge R, Nene BM, Esmy PO, Joshi S, Poli UR, Jivarajani P, Verma Y, Zomawia E, Siddiqi M, Shastri SS, Jayant K, Malvi SG, Lucas E, Michel A, Butt J, Vijayamma JM, Sankaran S, Kannan TP, Varghese R, Divate U, Thomas S, Joshi G, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Hingmire S, Kriplani A, Mishra G, Pimple S, Jadhav R, Sauvaget C, Tommasino M, Pillai MR; Indian HPV Vaccine Study Group. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016 Jan;17(1):67-77. doi: 10.1016/S1470-2045(15)00414-3. Epub 2015 Dec 2.
PMID: 26652797RESULTSankaranarayanan R, Joshi S, Muwonge R, Esmy PO, Basu P, Prabhu P, Bhatla N, Nene BM, Shaw J, Poli URR, Verma Y, Zomawia E, Pimple S, Tommasino M, Pawlita M, Gheit T, Waterboer T, Sehr P, Pillai MR; Indian HPV vaccine study group. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. doi: 10.1016/j.vaccine.2018.02.087. Epub 2018 Mar 15.
PMID: 29551226RESULTBhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Pimple S, Prabhu PR, Basu P, Muwonge R, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Kannan TPRA, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Kriplani A, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. doi: 10.1016/j.pvr.2018.03.008. Epub 2018 Mar 22.
PMID: 29578097RESULTBasu P, Muwonge R, Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Shastri SS, Pimple S, Anantharaman D, Prabhu PR, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Rameshwari Ammal Kannan TP, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Vashist S, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow-up cohort study. Papillomavirus Res. 2019 Jun;7:75-81. doi: 10.1016/j.pvr.2019.01.004. Epub 2019 Jan 31.
PMID: 30711698RESULTMuwonge R, Basu P, Gheit T, Anantharaman D, Verma Y, Bhatla N, Joshi S, Esmy PO, Poli URR, Shah A, Zomawia E, Shastri SS, Pimple S, Prabhu PR, Hingmire S, Chiwate A, Sauvaget C, Lucas E, Malvi SG, Siddiqi M, Sankaran S, Kannan TPRA, Varghese R, Divate U, Vashist S, Mishra G, Jadhav R, Tommasino M, Pillai MR, Sankaranarayanan R, Jayant K; Indian HPV vaccine study group. Acquisition, prevalence and clearance of type-specific human papillomavirus infections in young sexually active Indian women: A community-based multicentric cohort study. PLoS One. 2020 Dec 29;15(12):e0244242. doi: 10.1371/journal.pone.0244242. eCollection 2020.
PMID: 33373380RESULTBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Because of the suspension of all HPV vaccine studies for reasons not related to this trial, the study was able to recruit 17729 of the originally planned 20000 participants some of who received less than the originally planned vaccine dose schedule.
Results Point of Contact
- Title
- Dr Partha Basu
- Organization
- International Agency for Research on Cancer
Study Officials
- PRINCIPAL INVESTIGATOR
Partha Basu, MD
International Agency for Research on Cancer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Early Detection, Prevention and Infection Branch at IARC, WHO
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 18, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2017
Study Completion (Estimated)
July 1, 2026
Last Updated
September 28, 2023
Results First Posted
October 20, 2022
Record last verified: 2023-09