Gardasil Immunogenicity With Needle-Free Injection

NCT02363660 | Completed Phase 2 DMC

• 1 other identifier: GINI Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

HIV

Keywords

HIV-uninfected

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm I

EXPERIMENTAL

will receive standard dose (0.5mL) delivered by standard intramuscular injection using a needle and syringe.

Biological: GINI

Arm II

EXPERIMENTAL

will receive standard dose (0.5mL) delivered by intramuscular injection using the Pharmajet needle-free Stratis device.

Biological: GINI

Arm III

EXPERIMENTAL

will receive a reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device

Biological: GINI

Interventions

GINI BIOLOGICAL

Arm I; Arm II; Arm III

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Thai national
• Woman
• Age 18-26 years
• Has had no more than 5 lifetime sex partners
• HIV-uninfected
• Able to complete all of the protocol visits and has signed the consent form

You may not qualify if:

• \. Known contraindications to vaccination with Gardasil

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• University of California, San Francisco: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: February 16, 2015
• Study Start: January 1, 2014
• Primary Completion: December 15, 2022
• Study Completion: February 16, 2023
• Last Updated: February 17, 2023

Record last verified: 2021-03

Locations

TH (1)