Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India

• Register: ISRCTN
• Last refreshed on: 26 October 2021
• Main ID: ISRCTN98283094
• Date of registration: 30/06/2008
• Prospective Registration: No
• Primary sponsor: International Agency for Research on Cancer (IARC) (France)
• Public title: Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India
• Scientific title: Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India
• Date of first enrolment: 01/06/2008
• Target sample size: 16000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN98283094
• Study type: Interventional
• Study design: Two-arm multicentre cluster randomised trial (randomisation unit = villages) (Prevention)
• Phase: Not Specified

Countries of recruitment

India

Contacts

• Name: Rengaswamy Sankaranarayanan

Key inclusion & exclusion criteria

Inclusion criteria:
1. Apparently healthy, ambulant, unmarried girls aged 10 - 18 years and with intact uterus
2. Resident in the villages chosen for the study

Exclusion criteria: Girls with any severe and/or debilitating illness

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical precancerous lesions and cervical cancer
Cancer
Cervical cancer

Intervention(s)

Vaccination with the prophylactic quadrivalent vaccine of Merck (Gardasil®) which targets HPV 16, 18, 6 and 11 types for prevention of infection with the most common HPV 16 and 18 high risk types and associated cervical intraepithelial neoplasia (CIN).

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.

Primary Outcome(s)

1. The relative type specific immunogenicity in terms of the presence of serum neutralising antibodies to HPV 16 and 18 (serum anti-HPV L1 antibody [sL1Ab]) measured using a competitive Luminex immunoassay in blood sample collected from a 15% sample of girls at 7, 12, 24, 36 and 48 months from the first dose of the vaccine
2. HPV 16/18 antibody geometric mean titres (GMTs) induced by the different dose regimes at 7, 12, 24, 36 and 48 months
3. Relative HPV 6/11 type specific immune response in the different regimens in a sample of girls
4. The relative protection in terms of frequency of incident as well as persistent (12-month definition) HPV 16 and 18 infection
5. Frequency of incident infection by other non-targeted high-risk HPV types. Initial follow-up: 5 years. Extended follow-up: 15 years.
6. HPV 16- and 18-associated CIN 2-3, adenocarcinoma in-situ and invasive cancer following the two different dose regimes. Initial follow-up: 5 years. Extended follow-up: 15 years.
7. CIN and invasive cancer associated with non-included HPV types in the two study groups. Initial follow-up: 5 years. Extended follow-up: 15 years.

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

N/A

NCT00923702

Source(s) of Monetary Support

Bill and Melinda Gates Foundation (USA) - through the International Agency for Research on Cancer (IARC), World Health Organization (France)

Ethics review

Status:
Approval date:
Contact:

International Agency for Research on Cancer (IARC) Institutional Review Board, 18/02/2008

Results

• Results available: Yes
• Date Completed: 31/05/2013