Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

NCT ID: NCT00923702

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 22729 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2026-07-31

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.

Detailed Description

The suspension of vaccination resulted in girls receiving 3 doses (days 1, 60 and ≥180), receiving 2 doses (days 1 and ≥180), receiving 2 doses at days 1 and 60 due to incomplete treatment ("by default"), and receiving one dose by default. A first age and site-matched cohort of unvaccinated married women was recruited, starting in May 2012 to serve as the unvaccinated control group of women for the analysis of HPV incidence and persistence outcomes. A second age and site-matched (age and site matched to the vaccinated women undergoing screening) cohort of unvaccinated married women is being recruited starting in June 2017 and is to be used in addition to the first unvaccinated cohort for the assessment of the cervical neoplasia outcome.

Conditions

Cervical Cancer; Cervical Precancerous Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

3-dose

The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.

Group Type: ACTIVE_COMPARATOR

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Intervention Type: BIOLOGICAL

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.

2-dose

The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.

Group Type: EXPERIMENTAL

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Intervention Type: BIOLOGICAL

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.

2 doses by default

The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)

Group Type: EXPERIMENTAL

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Intervention Type: BIOLOGICAL

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.

Single-dose

The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)

Group Type: EXPERIMENTAL

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Intervention Type: BIOLOGICAL

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.

Unvaccinated

A cohort of unvaccinated women

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil®

Eligibility Criteria

Inclusion Criteria

• Apparently healthy, ambulant girls aged 10 - 18 years
• Unmarried girls
• Girls with intact uterus
• Resident in the villages chosen for the study

Exclusion Criteria

• Girls with any severe and/or debilitating illness
• Past history of allergy to any medication

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Cancer Foundation of India

OTHER

Sponsor Role: collaborator

Christian Fellowship Community Health Centre

OTHER

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Gujarat Cancer & Research Institute

OTHER

Sponsor Role: collaborator

Jehangir Clinical Development Centre

OTHER

Sponsor Role: collaborator

MNJ Institute of Oncology and Regional Cancer Center

OTHER_GOV

Sponsor Role: collaborator

Rajiv Gandhi Centre for Biotechnology

INDUSTRY

Sponsor Role: collaborator

Nargis Datta Memorial Cancer Hospital

OTHER

Sponsor Role: collaborator

Tata Memorial Centre

OTHER

Sponsor Role: collaborator

Partha Basu

OTHER

Sponsor Role: lead

Responsible Party

Partha Basu

Early Detection, Prevention and Infection Branch at IARC, WHO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Partha Basu, MD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

Locations

MNJ Institute of Oncology & Regional Cancer Center

Hyderabad, Andhra Pradesh, India

Gujarat Cancer & Research Institute (GCRI)

Ahmedabad, Gujarat, India

Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital

Barshi, Maharashtra, India

Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst

Mumbai, Maharashtra, India

Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.

Pune, Maharashtra, India

Christian Fellowship Community Health Centre

Ambilikkai, Tamil Nadu, India

Cancer Foundation of India

Kolkata, West Bengal, India

All India Institute of Medical Sciences

New Delhi, , India

Countries

India

References

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Reference Type: BACKGROUND

PMID: 34634254 (View on PubMed)

Sankaranarayanan 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.

Reference Type: RESULT

PMID: 26652797 (View on PubMed)

Sankaranarayanan 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.

Reference Type: RESULT

PMID: 29551226 (View on PubMed)

Bhatla 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.

Reference Type: RESULT

PMID: 29578097 (View on PubMed)

Basu 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.

Reference Type: RESULT

PMID: 30711698 (View on PubMed)

Muwonge 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.

Reference Type: RESULT

PMID: 33373380 (View on PubMed)

Other Identifiers

ISRCTN98283094

Identifier Type: OTHER

Identifier Source: secondary_id

REFCTRI-2009 000137

Identifier Type: REGISTRY

Identifier Source: secondary_id

BMGF48979

Identifier Type: -

Identifier Source: org_study_id