Result of Phase 1 Study of HIV Vaccine Study in India

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A Phase 1 Study to Evaluate the Safety and Immunogenicity of a

Recombinant HIV Type 1 Subtype C Adeno-Associated Virus Vaccine

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To cite this paper:

Sanjay Mehendale, Jan van Lunzen, Clumeck, Jurgen Rockstroh,

Eva Vets, Philip R. , Pervin Anklesaria, Burc Barin, Mark

Boaz, Sonali Kochhar, Lehrman, Schmidt, Mathieu

Peeters, Carolynne Schwarze-Zander, Kabeya Kabamba, Tobias

Glaunsinger, Seema Sahay, Madhuri Thakar, Ramesh Paranjape, Jill

Gilmour, Jean-Louis Excler, Fast, Alison E. Heald.

AIDS Research and Human Retroviruses. June 1, 2008, 24(6): 873-880.

doi:10.1089/aid.2008.0292.

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Sanjay Mehendale

National AIDS Research Institute, Pune, India.

Jan van Lunzen

University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Clumeck

St. Pierre University Hospital, Brussels, Belgium.

Jurgen Rockstroh

University Clinic, Bonn, Germany.

Eva Vets

SGS Biopharma, Antwerp, Belgium.

Philip R.

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

19104 and Columbus Children's Research Institute, Columbus, Ohio

43205.

Pervin Anklesaria

Targeted Genetics Corporation, Seattle, Washington 98101.

Burc Barin

EMMES Corporation, Rockville, land 20850.

Mark Boaz

International AIDS Vaccine Initiative, Core Laboratory, London, UK.

Sonali Kochhar

International AIDS Vaccine Initiative, New Delhi, India.

Lehrman

International AIDS Vaccine Initiative, New York, New York 10038.

Schmidt

International AIDS Vaccine Initiative, New York, New York 10038.

Mathieu Peeters

SGS Biopharma, Antwerp, Belgium.

Carolynne Schwarze-Zander

University Clinic, Bonn, Germany.

Kabeya Kabamba

St. Pierre University Hospital, Brussels, Belgium.

Tobias Glaunsinger

University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Seema Sahay

National AIDS Research Institute, Pune, India.

Madhuri Thakar

National AIDS Research Institute, Pune, India.

Ramesh Paranjape

National AIDS Research Institute, Pune, India.

Jill Gilmour

International AIDS Vaccine Initiative, Core Laboratory, London, UK.

Jean-Louis Excler

International AIDS Vaccine Initiative, New Delhi, India.

Fast

International AIDS Vaccine Initiative, New York, New York 10038.

Alison E. Heald

Targeted Genetics Corporation, Seattle, Washington 98101.

Abstract

A novel prophylactic AIDS vaccine candidate, consisting of single-

stranded DNA for HIV-1 subtype C gag, protease, and part of reverse

transcriptase genes, enclosed within a recombinant adeno-associated

virus serotype-2 protein capsid (tgAAC09) induced T cell responses

and antibodies in nonhuman primates. In this randomized, dose

escalation phase I trial, HIV-uninfected healthy volunteers (50 in

Europe, 30 in India) received a single intramuscular injection of

tgAAC09 at 3 × 109 DNase resistant particles (DRP) (n = 16), 3 × 1010

DRP (n = 23), 3 × 1011 DRP (n = 25), or placebo (n = 16).

Twenty-one participants in Europe received a second (boost) dose of

3 × 1011 DRP tgAAC09 or placebo at least 24 weeks after the first

injection. The vaccine was safe and well-tolerated after initial and

boost vaccination. Local and systemic reactogenicity was experienced

by 13–25% of participants and was not dose related.

No vaccine-related serious adverse events were reported. Modest HIV-

specific T cell responses were detected in 7/64 vaccinees (40–385

SFC/106 PBMC), with 16% (4/25) responders in the highest dose group.

All responses were to Gag epitopes. tgAAC09 appears to be safe, well-

tolerated, and modestly immunogenic. Further evaluation of higher

doses of tgAAC09 and boost injections is ongoing in Africa.