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

Conditions

Cervical precancerous lesions and cervical cancer Cancer Cervical cancer

Basu P, Malvi SG, Joshi S, Bhatla N, Muwonge R, Lucas E, Verma Y, Esmy PO, Poli URR, Shah A, Zomawia E, Pimple S, Jayant K, Hingmire S, Chiwate A, Divate U, Vashist S, Mishra G, Jadhav R, Siddiqi M, Sankaran S, Prabhu PR, Kannan TPRA, Varghese R, Shastri SS, Anantharaman D, Gheit T, Tommasino M, Sauvaget C, Pillai MR, Sankaranarayanan R.

2021-10-08172 citations

10.1016/s1470-2045(21)00453-8

Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study.

Sankaranarayanan R, Joshi S, Muwonge R, Esmy PO, Basu P, Prabhu P, Bhatla N, Nene BM, Shaw J, Poli URR, Verma Y, Zomawia E, Pimple S, Tommasino M, Pawlita M, Gheit T, Waterboer T, Sehr P, Pillai MR, Indian HPV vaccine study group.

2018-03-15123 citations

10.1016/j.vaccine.2018.02.087

Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study.

Sankaranarayanan R, Prabhu PR, Pawlita M, Gheit T, Bhatla N, Muwonge R, Nene BM, Esmy PO, Joshi S, Poli UR, Jivarajani P, Verma Y, Zomawia E, Siddiqi M, Shastri SS, Jayant K, Malvi SG, Lucas E, Michel A, Butt J, Vijayamma JM, Sankaran S, Kannan TP, Varghese R, Divate U, Thomas S, Joshi G, Willhauck-Fleckenstein M, Waterboer T, Müller M, Sehr P, Hingmire S, Kriplani A, Mishra G, Pimple S, Jadhav R, Sauvaget C, Tommasino M, Pillai MR, Indian HPV Vaccine Study Group.

2015-12-02188 citations

10.1016/s1470-2045(15)00414-3

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

India

Outcome results

None listed