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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00923702
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Results First Posted : October 20, 2022
Last Update Posted : October 20, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Partha Basu, International Agency for Research on Cancer

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22729 participants
Allocation: Non-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
Actual Study Start Date : September 2009
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Active Comparator: 3-dose
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Biological: 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.
Other Name: Gardasil®

Experimental: 2-dose
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Biological: 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.
Other Name: Gardasil®

Experimental: 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)
Biological: 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.
Other Name: Gardasil®

Experimental: Single-dose
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Biological: 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.
Other Name: Gardasil®

No Intervention: Unvaccinated
A cohort of unvaccinated women



Primary Outcome Measures :
  1. Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points [ Time Frame: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48 ]
    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.

  2. Frequency of Persistent HPV 16/18/6/11 Infection. [ Time Frame: From date of marriage through to 7 years of follow-up ]
    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.

  3. Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. [ Time Frame: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen ]
    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.


Secondary Outcome Measures :
  1. Frequency of Infection by Other Non-targeted High-risk HPV Types. [ Time Frame: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen ]
    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.

  2. Frequency of Cervical Neoplasia Associated With Non-included HPV Types. [ Time Frame: 15 years from the base-line date ]
    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 other non vaccine included HPV types by PCR in the same biopsy tissue sample.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923702


Locations
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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
Partha Basu
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
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Principal Investigator: Partha Basu, MD International Agency for Research on Cancer
Publications of Results:

Other Publications:
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Responsible Party: Partha Basu, Early Detection, Prevention and Infection Branch at IARC, WHO, International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT00923702    
Other Study ID Numbers: BMGF48979
ISRCTN98283094 ( Other Identifier: BioMedCentral )
REFCTRI-2009 000137 ( Registry Identifier: Indian Clinical Trial Registry )
First Posted: June 18, 2009    Key Record Dates
Results First Posted: October 20, 2022
Last Update Posted: October 20, 2022
Last Verified: November 2021
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases