Gardasil Immunogenicity With Needle-Free Injection

HIV Clinical Trial

— GINI  

Official title:

A Randomized, Parallel Design Study to Compare the Safety and Effectiveness of Gardasil When Delivered Per Standard Practice (Full Dose, Intramuscular (IM) Delivery Using a Needle and Syringe) vs. Full Dose, IM Delivery Via Needle-free Jet Injection or Reduced Dose, Intradermal Delivery Via Needle-free Jet Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363660
• Other study ID #: GINI Study
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: February 16, 2023

Study information

• Verified date: March 2021
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given low doses of vaccine by the ID route with the NFI (Group III) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 18 months following completion of the vaccination series.

2. Compare 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 18 months following completion of the vaccination series.

Description:

Primary hypotheses:

The primary goal of this study is to compare the vaccination groups. Using GMTs to measure immunogenicity of the 3 different vaccination regimens, we will test for non-inferiority between Group I and Group II and between Group I and Group III.

Our hypotheses are:

1. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the ID route with the NFI (Group III) will be non-inferior to GMTs in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of GMTs (GI/GIII) is less than 1.5 for all HPV types.

2. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) will be non-inferior to GMTs in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of GMTs (GI/GII) is less than 1.5 for all HPV types.

3. The proportions of baseline-naïve vaccinees seroconverting to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the ID route (Group III) and standard doses of vaccine by the IM route (Group II) with the NFI will be non-inferior to the seroconversion rates in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the difference in proportions is less than 10% for all HPV types.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 16, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

1. Thai national

2. Woman

3. Age 18-26 years

4. Has had no more than 5 lifetime sex partners

5. HIV-uninfected

6. Able to complete all of the protocol visits and has signed the consent form

Exclusion Criteria:

1. Known contraindications to vaccination with Gardasil

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• GINI

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	University of California, San Francisco

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle-free jet injection technology	The jet injector is based on simple, robust technology employing a spring and requiring no compressed gas, battery, or electricity to generate a liquid needle. PharmaJet has two product lines; one for intramuscular and subcutaneous (IM/SC) delivery of 0.5 mL and one for ID delivery of 0.1 mL. The IM/SC product, called Stratis, was FDA-cleared in 2011 and has a separate reset station to recharge the injector spring, while the ID product, Tropis, is in late stage product development and has the reset function integrated into the injector. Both products employ disposable, single-use, needle-free syringes and filling adapter components. To date the products have been used for routine vaccine delivery as well as in a number of clinical trials (including Inactivated Poliovirus Vaccine (IPV), HPV, and influenza). PharmaJet is working with vaccine manufacturers to co-develop custom pre-fillable syringes, e.g., a tetravalent Dengue vaccine with Inviragen.6	24 months