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HPV Vaccine Immunity in High-risk Women

NCT04590521 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-02-01

No results posted yet for this study

Summary

This is a single arm immunological study based in Vietnam. The study will examine human papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected for immunology and virology testing, respectively.

Conditions

Interventions

BIOLOGICAL

Gardasil®, Merck

Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine. Each 0.5 mL monodose pre-filled syringe or vial contains approximately 20 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 40 μg of HPV 16 L1 protein, and 20 μg of HPV 18 L1 protein as well as approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant). It has completed phase III trials and is licensed for use in over 100 countries around the world including the United States, Australia and countries in the European Union (EU) for girls aged 9-26 years. Vietnam currently offer this vaccine in private health clinics, as a 3-dose schedule (0, 2 and 6 months).

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Kim Mulholland, MBBS · Murdoch Childrens Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590521 on ClinicalTrials.gov