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GINI Study

Tue 27 Feb 2018 Clinical Research

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
Status: Analysis

What is GINI?
Gardasil Immunogenicity with Needle-free Injection (GINI) was a study to evaluate the safety and effectiveness of two HPV vaccine delivery regimens; by needle and syringe and needle free jet injection.

Who participated in GINI?
GINI enrolled a total of 150 Thai HIV-uninfected women in Bangkok. Participants were between the ages of 18 and 26 years with no history of HPV vaccination. The participants were enrolled for 24 months, with 6 follow-up visits.

Why was GINI important?
Needles and syringes are commonly used for immunization procedures. However, needle phobia makes immunizations stressful which results in high proportion of young Thai women not completing the full 3-dose series of HPV vaccination. Besides being less painful, we hope the needle- free injection will offer the possibility of using reduced dose of vaccine and reducing the cost of vaccination.

*The project is in collaboration with the University of California, San Francisco and sponsored by Merck & Co., Inc.