Gardasil Immunogenicity With Needle-Free Injection (GINI)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HPV Seroconversion

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01924754

13366

Details and patient eligibility

About

Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at UCSF will be testing the serum for antibodies to measure the strength of their response to the vaccine.

Full description

Primary Objectives

1. Compared rates of seroconversion and geometric mean titers (GMTs) generated following a 3-dose series of vaccine in women given low doses of vaccine by the intradermal (ID) route with the needle-free injector (NFI) (Group III) to those women given standard doses by the intramuscular (IM) route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
2. Compared rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.

Serum samples were collected on 4 successive occasions: (1) day zero, prior to the first immunization, (2) at visit 4, one month following the third and final immunization, (3) at visit 5 (12 months) and (4) and at visit 6 (24 months after enrollment). Samples were split, stored and transferred in batch for analysis.

Merck received samples for processing and determined the geometric mean titer of antibodies specific to HPV (types 6, 11, 16, and 18) and results were transferred to the principal investigator. The University of California, San Francisco (UCSF) used a portion of the collected blood samples for pseudovirion-based neutralisation assay (PBNA) analysis conducted at UCSF.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Thai women age 18-26 years
• No more than 5 lifetime sexual partners
• HIV-uninfected
• No history of HPV vaccination
• Judged able to complete all of the protocol visits
• No contraindications to vaccination with Gardasil

Exclusion criteria

• Does not satisfy all of the inclusion criteria

Trial design

150 participants in 3 patient groups

Standard intramuscular injection (NS-IM)

Description:

HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe (NS-IM)

PharmaJet needle-free Stratis device (JI-IM)

Description:

HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device (JI-IM)

PharmaJet needle-free Tropis device (JI-ID)

Description:

HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device (JI-ID)