HPV Vaccine Immunity in High-risk Women

NCT04590521 | Completed Phase 4

• 1 other identifier: HREC 2019.225
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

HPV Infection

Keywords

HPV vaccine

Outcome Measures

Primary Outcomes (2)

• Neutralising antibody (NAb) levels to HPV16

  Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.

  7 months

• Neutralising antibody (NAb) levels to HPV18

  Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.

  7 months

Secondary Outcomes (12)

• NAb titres to HPV16 and 18 at baseline

  Baseline

• NAb titres to HPV16 and 18 following one dose of Gardasil

  Month 2

• NAb titres to HPV16 and 18 following second dose of Gardasil

  Month 3

• NAb titres to HPV 52 and 58 at baseline

  Baseline

• NAb titres to HPV52 and 58 following one dose of Gardasil

  Month 2

Study Arms (1)

Intervention

EXPERIMENTAL

A standard 3-dose schedule (0, 2 and 6 months) of licensed HPV vaccine (Gardasil®, Merck) will be administered to all participants intramuscularly.

Biological: Gardasil®, Merck

Interventions

Gardasil®, Merck BIOLOGICAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Each participant must meet all of the following criteria to be enrolled in this trial:
• Is between the reporting ages of 18-25 years at the time of recruitment
• Engage in commercial sex in the last month

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• London School of Hygiene and Tropical Medicine: collaborator
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (1)

Hai Phong District Health Centre

Haiphong, Vietnam

Location

Related Publications (1)

• Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, Carletti I, Dessy FJ, Trofa AF, Schuind A, Dubin G; HPV-010 Study Group. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin. 2009 Oct;5(10):705-19. doi: 10.4161/hv.5.10.9518. Epub 2009 Oct 14.

  PMID: 19684472 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Kim Mulholland, MBBS

  Murdoch Childrens Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will be given Gardasil (Merck) HPV vaccine

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: October 19, 2020
• Study Start: September 14, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Data requests from individuals or research groups outside MCRI will be reviewed by MCRI and the Sponsor-Investigator in accordance with MCRI's Data Sharing and Access Procedure for the Release of Data from MCRI Sponsored Investigator-Initiated Clinical Trials (MCTC079)

Locations

VN (1)