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

ISRCTN ISRCTN98283094
DOI https://doi.org/10.1186/ISRCTN98283094
ClinicalTrials.gov number NCT00923702
Secondary identifying numbers N/A
Submission date
17/03/2008
Registration date
30/06/2008
Last edited
12/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rengaswamy Sankaranarayanan
Scientific

150 Cours Albert Thomas
Lyon
69372 Cedex 08
France

Phone +33 (0)4 72 73 85 14
Email sankar@iarc.fr

Study information

Study designTwo-arm multicentre cluster randomised trial (randomisation unit = villages)
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Not specified
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRandomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India
Study objectivesThe 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(s)International Agency for Research on Cancer (IARC) Institutional Review Board, 18/02/2008
Health condition(s) or problem(s) studiedCervical precancerous lesions and cervical cancer
InterventionVaccination 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 typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/06/2008
Completion date31/05/2013

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit10 Years
Upper age limit18 Years
SexFemale
Target number of participants16,000
Key inclusion criteria1. Apparently healthy, ambulant, unmarried girls aged 10 - 18 years and with intact uterus
2. Resident in the villages chosen for the study
Key exclusion criteriaGirls with any severe and/or debilitating illness
Date of first enrolment01/06/2008
Date of final enrolment11/04/2012

Locations

Countries of recruitment

  • India

Study participating centre

-
-
-
India

Sponsor information

International Agency for Research on Cancer (IARC) (France)
Government

World Health Organization
150 cours Albert Thomas
Lyon
69372 cedex 08
France

Phone +33 (0)4 72 73 85 14
Email sankar@iarc.fr
Website http://screening.iarc.fr
ROR logo "ROR" https://ror.org/00v452281

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2016 Yes No
Results article early results 06/08/2018 Yes No
Results article 08/10/2021 12/10/2021 Yes No

Editorial Notes

12/10/2021: Publication reference added.
21/03/2018: Publication reference added.