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

International Agency for Research on Cancer

Status: Enrolling

Conditions: Cervical Cancer

Treatments: 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.

Study type: Observational

Funder types: Other

Identifiers

NCT04588402

SMIMS/IEC/C/2020-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,500 estimated patients

Sex: Female

Ages: 18 to 22 years old

Volunteers: Accepts Healthy Volunteers

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