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

Partha Basu

Status and phase: Active, not recruiting; Phase 4

Conditions: Cervical Precancerous Lesions; Cervical Cancer

Treatments: Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00923702

ISRCTN98283094 (Other Identifier)

REFCTRI-2009 000137 (Registry Identifier)

BMGF48979

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22,729 patients

Sex: Female

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22,729 participants in 5 patient groups

3-dose

Active Comparator group

Description:

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

Treatment:

Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

2-dose

Experimental group

Description:

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

Treatment:

Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

2 doses by default

Experimental group

Description:

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

Treatment:

Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Single-dose

Experimental group

Description:

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

Treatment:

Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)

Unvaccinated

No Intervention group

Description:

A cohort of unvaccinated women