Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India (HPV-Vac-S)

March 30, 2026 updated by: International Agency for Research on Cancer

Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.

Study Type

Observational

Enrollment (Estimated)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Partha Basu, MD, PhD
  • Phone Number: +33 472 738 167
  • Email: basup@iarc.fr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons.

Description

Inclusion Criteria:

  • Women aged 18 to 22 years, resident of Sikkim and married.
  • Pregnancy will not be considered as exclusion criteria.
  • Sample collection should be avoided during active menstruation.

Exclusion Criteria:

  • Women who do not provide written consent
  • Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses.
  • Women who had undergone hysterectomy.
  • Vaccinated in research project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The reduction in the point prevalence of genotype-specific HPV infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
Time Frame: 7 years
The investigators will estimate difference in the prevalence of genotype-specific HPV infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program).
7 years
The difference in the point prevalence of chlamydia trachomatis infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
Time Frame: 7 years
The investigators will estimate difference in the prevalence of chlamydia trachomatis infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program). The estimate will allow the investigators to understand any change in the background risk of sexually transmitted infection in the population over time.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Collaborators

Rajiv Gandhi Centre for Biotechnology
Department of Health and Family welfare, Government of Sikkim
Sikkim Manipal Institute

Investigators

  • Principal Investigator: Yogesh Verma, MD, Sikkim Manipal Inst., Sikkim, India
  • Principal Investigator: Phumzay Denzongpa, MD, Dept of H & FW, Govt. of Sikkim, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMIMS/IEC/C/2020-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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