학술논문
Safety and immunogenicity of DNA and MVA HIV-1 subtype C vaccine prime-boost regimens: a phase I randomised Trial in HIV-uninfected Indian volunteers.
Document Type
article
Author
Sanjay Mehendale; Madhuri Thakar; Seema Sahay; Makesh Kumar; Ashwini Shete; Pattabiraman Sathyamurthi; Amita Verma; Swarali Kurle; Aparna Shrotri; Jill Gilmour; Rajat Goyal; Len Dally; Eddy Sayeed; Devika Zachariah; James Ackland; Sonali Kochhar; Josephine H Cox; Jean-Louis Excler; Vasanthapuram Kumaraswami; Ramesh Paranjape; Vadakkuppatu Devasenapathi Ramanathan
Source
PLoS ONE, Vol 8, Iss 2, p e55831 (2013)
Subject
Language
English
ISSN
1932-6203
Abstract
STUDY DESIGN: A randomized, double-blind, placebo controlled phase I trial. METHODS: The trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos. RESULTS: Both vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p