Clinical trial NCT01924754: Gardasil Immunogenicity With Needle-Free Injection
Official title: GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Seroconversion
Keywords: HPV
Gardasil
seroconversion
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-08-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was for women and focused on the safety and immunogenicity of the HPV vaccine. Separate studies will be done in men if the dosing regimens in Groups II or III are shown to be non-inferior to the standard regimen

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
timeFrame: Baseline, up to 1 day
measure: Percentage of Participants With a Demonstrated Seroconversion for HPV 6
timeFrame: Up to 7 months
measure: Percentage of Participants With a Demonstrated Seroconversion for HPV 11
timeFrame: Up to 7 months
measure: Percentage of Participants With a Demonstrated Seroconversion for HPV 16
timeFrame: Up to 7 months
measure: Percentage of Participants With a Demonstrated Seroconversion for HPV 18
timeFrame: Up to 7 months
measure: Median Concentration for HPV 6 Over Time
timeFrame: Up to 7 months
measure: Median Concentration for HPV 11 Over Time
timeFrame: Up to 7 months
measure: Median Concentration for HPV 16 Over Time
timeFrame: Up to 7 months
measure: Median Concentration for HPV 18 Over Time
timeFrame: Up to 7 months
measure: Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre
Study officials:
affiliation: University of California, San Francisco
name: Joel Palefsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: