Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

Cervical Cancer Clinical Trial

— HPV-Vac-S  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588402
• Other study ID #: SMIMS/IEC/C/2020-09
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: International Agency for Research on Cancer
• Contact: Partha Basu, MD, PhD
• Phone: +33 472 738 167
• Email: basup[@]iarc.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Papillomavirus Infections

Intervention

Biological:
• 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.
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.

Locations

Country	Name	City	State
India	Sikkim Manipal Hospital	Gangtok	Sikkim

Sponsors (4)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Department of Health and Family welfare, Government of Sikkim, Rajiv Gandhi Centre for Biotechnology, Sikkim Manipal Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	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