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L'essai clinique NCT00923702 pour Cancer du col de l'utérus, Cervical Precancerous Lesions est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
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L'essai clinique NCT00923702 est conçu pour étudier la prevention de Cancer du col de l'utérus, Cervical Precancerous Lesions. Il s'agit d'un essai interventionnel en Phase IV. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 1 septembre 2009 et vise à recruter 22 729 participants. Dirigé par Partha Basu, l'essai devrait être terminé d'ici le 1 juillet 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 septembre 2023.
Résumé succinct
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.
Description détaillée
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.
Titre officiel
Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Conditions
Cancer du col de l'utérusCervical Precancerous LesionsPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:- 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. Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1518-1529. doi: 10.1016/S1470-2045(21)00453-8. Epub 2021 Oct 8.
- 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, Muller M, Sehr P, Hingmire S, Kriplani A, Mishra G, Pimple S, Jadhav R, Sauvaget C, Tommasino M, Pillai MR; Indian HPV Vaccine Study Group. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016 Jan;17(1):67-77. doi: 10.1016/S1470-2045(15)00414-3. Epub 2015 Dec 2.
- 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. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. doi: 10.1016/j.vaccine.2018.02.087. Epub 2018 Mar 15.
- Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Pimple S, Prabhu PR, Basu P, Muwonge R, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Kannan TPRA, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Kriplani A, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. doi: 10.1016/j.pvr.2018.03.008. Epub 2018 Mar 22.
- Basu P, Muwonge R, Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Shastri SS, Pimple S, Anantharaman D, Prabhu PR, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Rameshwari Ammal Kannan TP, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Vashist S, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow-up cohort study. Papillomavirus Res. 2019 Jun;7:75-81. doi: 10.1016/j.pvr.2019.01.004. Epub 2019 Jan 31.
- Muwonge R, Basu P, Gheit T, Anantharaman D, Verma Y, Bhatla N, Joshi S, Esmy PO, Poli URR, Shah A, Zomawia E, Shastri SS, Pimple S, Prabhu PR, Hingmire S, Chiwate A, Sauvaget C, Lucas E, Malvi SG, Siddiqi M, Sankaran S, Kannan TPRA, Varghese R, Divate U, Vashist S, Mishra G, Jadhav R, Tommasino M, Pillai MR, Sankaranarayanan R, Jayant K; Indian HPV vaccine study group. Acquisition, prevalence and clearance of type-specific human papillomavirus infections in young sexually active Indian women: A community-based multicentric cohort study. PLoS One. 2020 Dec 29;15(12):e0244242. doi: 10.1371/journal.pone.0244242. eCollection 2020.
- Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
Autres identifiants de l'essai
- BMGF48979
- ISRCTN98283094 (Autre Identifiant) (BioMedCentral)
- REFCTRI-2009 000137 (Identifiant de registre) (Indian Clinical Trial Registry)
Numéro NCT
Date de début (réel)
2009-09
Dernière mise à jour publiée
2023-09-28
Date de fin (estimée)
2026-07
Inscription (estimée)
22 729
Type d'essai
Interventionnel
PHASE
Phase IV
Statut
Actif, pas en recrutement
Objectif principal
Prévention
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actif3-dose The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+. | Prophylactic Quadrivalent HPV Vaccine Merck (Gardasil®) The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. |
Expérimental2-dose The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+. | Prophylactic Quadrivalent HPV Vaccine Merck (Gardasil®) The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. |
Expérimental2 doses by default The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses) | Prophylactic Quadrivalent HPV Vaccine Merck (Gardasil®) The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. |
ExpérimentalSingle-dose The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses) | Prophylactic Quadrivalent HPV Vaccine Merck (Gardasil®) The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. |
Aucune interventionUnvaccinated A cohort of unvaccinated women | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points | Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA. | Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48 |
Frequency of Persistent HPV 16/18/6/11 Infection. | The first cervical cell samples were collected from women 18 months after married or 6 months after the first delivery. After that, 3 extra annual collections were obtained. The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome. | From date of marriage through to 7 years of follow-up |
Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. | Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of HPV 16 and/or HPV 18 by PCR in the same biopsy tissue sample. | Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Frequency of Infection by Other Non-targeted High-risk HPV Types. | The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome. | Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen |
Frequency of Cervical Neoplasia Associated With Non-included HPV Types. | Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of other non vaccine included HPV types by PCR in the same biopsy tissue sample. | 15 years from the base-line date |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte
Âge minimum
10 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
- Apparently healthy, ambulant girls aged 10 - 18 years
- Unmarried girls
- Girls with intact uterus
- Resident in the villages chosen for the study
- Girls with any severe and/or debilitating illness
- Past history of allergy to any medication
Partha Basu
Institut indien des sciences médicales50 essais cliniques actifs à explorer- 🧬Cancer Foundation of India
- ⚕️Christian Fellowship Community Health Centre
- 🔬German Cancer Research Center
- 🔬Gujarat Cancer & Research Institute
- 🏥Jehangir Clinical Development Centre
- 🎗️MNJ Institute of Oncology and Regional Cancer Center
- 🧬Rajiv Gandhi Centre for Biotechnology
- 🏥Nargis Datta Memorial Cancer Hospital
- 🏥Tata Memorial Centre
Partie responsable de l'essai
Partha Basu, Promoteur-Investigateur, Early Detection, Prevention and Infection Branch at IARC, WHO, International Agency for Research on Cancer
Aucune donnée de contact disponible
8 Centres de l'essai dans 1 pays
Andhra Pradesh
MNJ Institute of Oncology & Regional Cancer Center, Hyderabad, Andhra Pradesh, 500004, India
Gujarat
Gujarat Cancer & Research Institute (GCRI), Ahmedabad, Gujarat, 380 016, India
Maharashtra
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi, Maharashtra, 413 401, India
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst, Mumbai, Maharashtra, 400 012, India
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd., Pune, Maharashtra, 411 001, India
Tamil Nadu
Christian Fellowship Community Health Centre, Ambilikkai, Tamil Nadu, 624612, India
West Bengal
Cancer Foundation of India, Kolkata, West Bengal, 700031, India
All India Institute of Medical Sciences, New Delhi, 110029, India