Gardasil Immunogenicity With Needle-Free Injection (GINI)

GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery

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.

Study Overview

• Status: Completed
• Conditions: HPV Seroconversion

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Thai Red Cross Aids Research Centre
• United States
  • California
    • San Francisco, California, United States, 94062
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Standard intramuscular injection (NS-IM); 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); 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); HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device (JI-ID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type	Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type	Baseline, up to 1 day
Percentage of Participants With a Demonstrated Seroconversion for HPV 6	The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 6 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.	Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 11	The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 11 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.	Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 16	The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 16 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.	Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 18	The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 18 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.	Up to 7 months
Median Concentration for HPV 6 Over Time	The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated	Up to 7 months
Median Concentration for HPV 11 Over Time	The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated	Up to 7 months
Median Concentration for HPV 16 Over Time	The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated	Up to 7 months
Median Concentration for HPV 18 Over Time	The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated	Up to 7 months
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type	The Geometric Mean Concentration Ratio (GMCR) and 95% confidence interval for both NS-IM versus JI-IM and NS-IM versus JI-ID was computed for the intent to treat population. Non-inferiority for arms JI-IM and JI-ID was defined as geometric mean concentration ratio (GMCR) <1.5 of NS-IM at month 7	Up to 7 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Joel Palefsky, M.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): May 31, 2016

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: HPV; seroconversion; Gardasil
• Other Study ID Numbers: 13366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes