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NCT Number: NCT04588402

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–22 year

Sex eligibility

Female

Study type

Observational

Primary location

Sikkim Manipal Hospital

Gangtok, Sikkim, 737107, India

Location status: Recruiting

Location contact

Yogesh Verma, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The study being observational in nature, there is no intervention. The investigators will only collect cervical samples from married women within a specified age range at different intervals.

Biological

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons. After signing the informed consent, the participants will fill in a risk factor questionnaire to study the socio-demographic information, sexual history and HPV vaccination history and the determinent of HPV infection. The questionnaire will be administered by a trained social worker or nurse.

A gynecologist will collect cervical cells from the participant's cervix during a gynecological examination. The cervical specimen will be examined for presence of specific HPV genotypes and Chlamydia infection.

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Partha Basu, MD, PhD

CONTACT

[email protected]

+33 472 738 167

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HPV-Vac-S

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2020
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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