New HIV/AIDS Vaccine Clinical Trials Begin at Emory Vaccine Center’s Hope Clinic

NIH-Supported HVTN Network Enrolls Healthy, Uninfected Adults in Phase 1 and 2 Studies

The Hope Clinic of the Emory Vaccine Center is enrolling volunteer participants in two new clinical trials of two different HIV/AIDS vaccines in healthy, uninfected individuals who are at low risk for acquiring HIV infection. Both studies are sponsored by the HIV Vaccine Trials Network (HVTN), which is funded and supported by the National Institutes of Health. HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines.

A phase 2a study, HVTN 205, will test the safety and immune-stimulating effectiveness of a vaccine developed by GeoVax, Inc., an Atlanta biotech company spun out of research at the Emory Vaccine Center and Yerkes National Primate Research Center. The vaccine consists of two components--a recombinant DNA vaccine and a recombinant modified vaccinia Ankara (MVA) vector-based vaccine. The DNA and MVA vaccines are used in a prime-boost protocol, with priming by the DNA vaccine and boosting by the MVA vaccine.

The protocol is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. The MVA virus is a vector used to deliver pieces of genetic material from HIV. Both vaccine components express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS.

Harriet Robinson, PhD, formerly of the Emory Vaccine Center and Emory’s Yerkes National Primate Research Center, developed the core vaccine technologies with colleagues at the National Institutes of Health, the Centers for Disease Control and Prevention and GeoVax. Robinson currently is senior vice president of research and development at GeoVax.

HVTN 205 will enroll a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients; ages 18 to 50 years) at 13 HVTN sites, including 11 in the United States and two in Peru. Sites include Emory; Harvard Medical School; Vanderbilt University; University of Rochester; Fred Hutchinson Cancer Research Center, Seattle; San Francisco Department of Public Health; University of Alabama, Birmingham; and sites at Columbia University, Union Square, and the Bronx in New York City; and Iquitos and Miraflores (Lima) in Peru.

A phase 1b study, HVTN 077, will test the safety and immune response to different combinations of an experimental HIV vaccine developed by the Vaccine Research Center of the National Institutes of Health. The vaccine consists of two components—a recombinant DNA vaccine and two recombinant adenovirus vector- vaccines. The DNA vaccine contains pieces of man-made DNA that are similar to the DNA found in HIV. The study vaccine does not contain any live HIV particle but only non-infectious virus-like particles that cannot cause AIDS. The other 2 “adenoviral vectors” are made out of 2 kinds of adenovirus. Adenoviruses are best known to cause colds and respiratory infections. The adenovirus vectors used in this study have been changed so they can not cause infections.

HVTN 077 will enroll a total of 192 volunteers (164 vaccine recipients and 28 placebo recipients) at 7 HVTN sites in the US, including: Atlanta, Birmingham, Harvard, Nashville, New York, Rochester, San Francisco Department of Public Health. Only healthy, HIV uninfected, low risk individuals between the age of 18 and 50 and who meet the inclusion criteria will be recruited to participate in the study.

“We are pleased to take part in these important clinical study of an HIV/AIDS vaccine,” says Mark Mulligan, MD, director of the Hope Clinic of the Emory Vaccine Center. “The search for an effective vaccine remains a critical goal in the fight against this challenging disease.”

Emory University has an equity interest in GeoVax and is entitled to sales royalties for the vaccine technologies being studied. Emory may financially benefit from these interests, if GeoVax is successful in marketing its vaccine.

For more information about these two clinical trials, visit http://www.hopeclinic.emory.edu or call 404-712-1371 or 877-424-HOPE.
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