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

Study Description

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Brief Summary:

The primary study hypothesis is that 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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer; Cervical Precancerous Lesions	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Study Start Date :	September 2009
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2021

Arms and Interventions

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Arm	Intervention/treatment
2 doses of vaccine; The participants will receive two doses of the vaccine at Day 1 and Day 180.	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®); The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180.; Other Name: Gardasil®
3 doses of vaccine; The participants will receive three doses of the vaccine at Day 1, Day 60, and Day 180.	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®); The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180.; Other Name: Gardasil®

Outcome Measures

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Primary Outcome Measures :

1. Geometric mean titers of serum neutralizing antibodies to vaccine included HPV types (16/18/6/11) at 7, 12, 24, 36, 48 months. [ Time Frame: 5 years from the base-line date ]
2. Frequency of incident and persistent HPV 16/18/6/11 infection. [ Time Frame: 5 years from the base-line date ]

Secondary Outcome Measures :

1. Frequency of infection by other non-targeted high-risk HPV types. [ Time Frame: 15 years from the base-line date ]
2. Frequency of HPV 16/18-associated precancerous lesions and cancer. [ Time Frame: 15 years from the base-line date ]
3. Frequency of cervical neoplasia associated with non-included HPV types. [ Time Frame: 15 years from the base-line date ]

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

India
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Andhra Pradesh, India, 500004
Cancer Foundation of India
Kolkata, Bengal, India, 700031
Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, Gujarat, India, 380 016
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital
Barshi, Maharashtra, India, 413 401
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Mumbai, Maharashtra, India, 400 012
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.
Pune, Maharashtra, India, 411 001
Christian Fellowship Community Health Centre
Ambilikkai, Tamil Nadu, India, 624612
All India Institute of Medical Sciences
New Delhi, India, 110029

Sponsors and Collaborators

Dr R. Sankaranarayanan

All India Institute of Medical Sciences, New Delhi

Cancer Foundation of India

Christian Fellowship Community Health Centre

Deutsches Krebsforschungszentrum (DKFZ)

Gujarat Cancer & Research Institute

Jehangir Clinical Development Centre

MNJ Institute of Oncology & Regional cancer Center

Rajiv Gandhi Centre for Biotechnology

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

Tata Memorial Centre

Investigators

Principal Investigator:	Rengaswamy Sankaranarayanan, MD	International Agency for Research on Cancer

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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, Müller 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.

Responsible Party:	Dr R. Sankaranarayanan, Head, Early Detection and Precention Section, International Agency for Research on Cancer
ClinicalTrials.gov Identifier:	NCT00923702 History of Changes
Other Study ID Numbers:	BMGF48979; ISRCTN98283094 ( Other Identifier: BioMedCentral ); REFCTRI-2009 000137 ( Registry Identifier: Indian Clinical Trial Registry )
First Posted:	June 18, 2009
Last Update Posted:	September 1, 2016
Last Verified:	August 2016

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Vaccines; Immunologic Factors; Physiological Effects of Drugs