Gardasil Immunogenicity With Needle-Free Injection

HPV Seroconversion Clinical Trial

— GINI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924754
• Other study ID #: 13366
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: May 31, 2016

Study information

• Verified date: August 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV Seroconversion

Locations

Country	Name	City	State
Thailand	Thai Red Cross AIDS Research Centre	Bangkok
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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