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Search / Trial NCT06681636

Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

Launched by NATIONAL INSTITUTE OF HYGIENE AND EPIDEMIOLOGY, VIETNAM · Nov 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Human Papillomavirus Hpv Vaccine Vietnam Female Sex Workers Immunogenicity Protection Extended Schedule Hpv Infection Cervical Cancer

ClinConnect Summary

This clinical trial is studying how well a different schedule for the HPV vaccine Gardasil-9 works in women who may be at high risk for HPV-related health issues, such as cervical cancer and genital warts. Specifically, the trial will compare a new vaccination schedule, where participants receive three doses over 18 months, to the standard schedule of three doses over six months. The goal is to see if the extended schedule provides similar protection and immune response against HPV as the standard schedule.

To be eligible for this trial, participants should be women aged 18 to 26 who have engaged in sexual activity, including those who may work in commercial sex. They must be willing to give their consent to participate and complete follow-up requirements. However, women who are pregnant, have previously received any HPV vaccine, have certain health conditions, or are taking specific medications will not be able to join the study. If you participate, you can expect to receive the vaccine according to the schedule and to have follow-up visits to monitor your health and response to the vaccine. This study is not yet recruiting participants, but it aims to help improve HPV vaccination strategies for women at risk.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Is between the reporting ages of 18-26 years at the time of recruitment.
  • Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
  • Willing and able to give written informed consent.
  • Willing to complete the follow-up requirements of the study.
  • Exclusion criteria
  • Participants meeting any of the following criteria will be excluded from the trial:
  • Pregnant or possibly pregnant
  • Has received any HPV vaccine previously
  • Has an axillary temperate greater than 38°C
  • Known allergies to any vaccine component
  • incapacity to provide consent
  • Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
  • Known HIV infection.
  • Known Congenital immune deficiency syndrome.

About National Institute Of Hygiene And Epidemiology, Vietnam

The National Institute of Hygiene and Epidemiology (NIHE) in Vietnam is a premier research organization dedicated to advancing public health through rigorous scientific investigation and epidemiological studies. As a key entity under the Ministry of Health, NIHE focuses on the prevention and control of infectious diseases, as well as the promotion of community health initiatives. The institute plays a vital role in conducting clinical trials that adhere to international standards, facilitating the development of innovative health solutions and contributing to the global body of knowledge in epidemiology and hygiene. Through its commitment to research excellence and collaboration, NIHE aims to enhance the health and well-being of populations in Vietnam and beyond.

Locations

Parkville, Victoria, Australia

Hai Phong, , Vietnam

Hai Phong, , Vietnam

Patients applied

0 patients applied

Trial Officials

Hong T Duong, MD, PhD

Study Director

National Institute of Hygiene and Epidemiology, Vietnam

Trang V Nguyen, PhD

Principal Investigator

National Institute of Hygiene and Epidemiology, Vietnam

Tuan A Le, MD, PhD

Principal Investigator

National Institute of Hygiene and Epidemiology, Vietnam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported