A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants
Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a
way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not
able to achieve their desired response. An alternative strategy to the antibody approach is
the stimulation of HIV-specific CD8 T-lymphocyte (CTL) responses. CTL responses were
previously demonstrated to play an important role in the control of simian immunodeficiency
virus (SIV), the HIV equivalent seen in rhesus macaque monkeys. Additionally, other studies
suggest CTLs play an important role in viral control during chronic infection. Based on this
information, several groups have shifted their focus to the development of CTL-based
vaccines, some of which have entered advanced clinical trials.
A DNA/rMVA vaccine strategy is structured to bring about both T-cell and antibody responses.
The primary vaccination is DNA based and will express only HIV proteins as a way to produce
an HIV-focused immune response. An rMVA vaccine strategy expresses both HIV and MVA proteins
and may amplify the focused response of a DNA vaccination. Participants in this study will
receive either a combined DNA/rMVA vaccine strategy, in which they receive both types of
vaccines; an rMVA vaccine strategy, in which they receive only the rMVA vaccine; or a
placebo. The DNA and rMVA are physically two different vaccinations given at separate times,
but in the DNA/rMVA group, they will be used together to make up one preventive regimen.
Both vaccine components express noninfectious virus-like particles.
This study is a multicenter, randomized study that is conducted in two parts and comprised
of five groups. In all groups, participants will receive four injections. In Part A, Groups
1 and 2 will be compared. In Group 1, participants will receive two shots of the DNA vaccine
and two shots of the rMVA vaccine. In Group 2, participants will receive four placebo
injections. In Part B, Groups 3, 4, and 5 will be compared. In Group 3, the combination
vaccine strategy will be used again; in Group 4, a single-vaccine strategy of three
injections of the rMVA vaccine and one injection of placebo will be given; and in Group 5,
participants will again receive four placebo injections. The study will last for a total of
12 months for participants, including enrollment and follow-up.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Frequency of severe local and systemic reactogenicity signs and symptoms
Throughout study
Yes
Paul A Goepfert, MD
Study Chair
UAB, Div. of Infectious Diseases
United States: Food and Drug Administration
HVTN 205
NCT00820846
January 2009
August 2012
Name | Location |
---|---|
Alabama Vaccine CRS | Birmingham, Alabama 35294 |
San Francisco Vaccine and Prevention CRS | San Francisco, California 94102 |
Brigham and Women's Hosp. CRS | Boston, Massachusetts 02115 |
Fenway Community Health Clinical Research Site (FCHCRS) | Boston, Massachusetts 02215 |
NY Blood Ctr./Bronx CRS | Bronx, New York 10455 |
HIV Prevention & Treatment CRS | New York, New York 10032 |
NY Blood Ctr./Union Square CRS | New York, New York 10003 |
Univ. of Rochester HVTN CRS | Rochester, New York 14642 |
Vanderbilt Vaccine CRS | Nashville, Tennessee 37232 |
FHCRC/UW Vaccine CRS | Seattle, Washington 98104 |
Hope Clinic of the Emory Vaccine Center CRS | Decatur, Georgia 30030 |