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Clinical Trials

MainTitle

Gardasil Immunogenicity With Needle-Free Injection (GINI)

This study has been enrolling by invitation
Sponsor
Thai Red Cross AIDS Research Centre

Collaborator
University of California, San Francisco

Information provided by (Responsible Party)
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier
NCT02363660

First received: October 16, 2014
Last updated: January 17, 2017
Last Verified: October 2016
History of Changes
Purpose

Purpose

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.

    li> 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.

Condition Intervention Phase
HIV

Biological : GINI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures

  • Needle-free jet injection technology [ Time Frame: 24 months ]
    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

Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm I
will receive standard dose (0.5mL) delivered by standard intramuscular injection using a needle and syringe.
Biological: GINI
Experimental: Arm II
will receive standard dose (0.5mL) delivered by intramuscular injection using the Pharmajet needle-free Stratis device.
Biological: GINI
Experimental: Arm III
will receive a reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
Biological: GINI

Detailed 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 26 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02363660

Locations

Thailand
The Thai Red Cross AIDS Research Centre
Pathumwan,, Bangkok, Thailand, 10330

Sponsors and Collaborators

Thai Red Cross AIDS Research Centre
University of California, San Francisco
More Information

More Information


Responsible Party: Thai Red Cross AIDS Research Centre  
ClinicalTrials.gov Identifier: NCT02363660   History of Changes  
Other Study ID Numbers: GINI Study  
Study First Received: October 16, 2014  
Last Updated: January 17, 2017  

Keywords provided by Thai Red Cross AIDS Research Centre:

HIV-uninfected

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.