Contact information
Type
Scientific
Primary contact
Dr Rengaswamy Sankaranarayanan
ORCID ID
Contact details
150 Cours Albert Thomas
Lyon
69372 Cedex 08
France
+33 (0)4 72 73 85 14
sankar@iarc.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00923702
Protocol/serial number
N/A
Study information
Scientific title
Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India
Acronym
Study hypothesis
The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen over six months would offer similar immunogenicity and protection as that of a three-dose regimen to girls against infection and cervical neoplasia caused by HPV types included in the vaccine and any oncogenic HPV types.
Ethics approval
International Agency for Research on Cancer (IARC) Institutional Review Board, 18/02/2008
Study design
Two-arm multicentre cluster randomised trial (randomisation unit = villages)
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cervical precancerous lesions and cervical cancer
Intervention
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.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
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 measures
No secondary outcome measures
Overall trial start date
01/06/2008
Overall trial end date
31/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Child
Gender
Female
Target number of participants
16,000
Participant exclusion criteria
Girls with any severe and/or debilitating illness
Recruitment start date
01/06/2008
Recruitment end date
11/04/2012
Locations
Countries of recruitment
India
Trial participating centre
-
-
-
Sponsor information
Organisation
International Agency for Research on Cancer (IARC) (France)
Sponsor details
World Health Organization
150 cours Albert Thomas
Lyon
69372 cedex 08
France
+33 (0)4 72 73 85 14
sankar@iarc.fr
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Bill and Melinda Gates Foundation (USA) - through the International Agency for Research on Cancer (IARC), World Health Organization (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26652797
2018 early results in: http://www.ncbi.nlm.nih.gov/pubmed/29551226