The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
The purpose of this study is to evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and IL-12 DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults. All study injections will be given using an EP device, which uses an electric pulse to briefly open tiny pores in the cells. Researchers will evaluate whether EP increases the immune response to the vaccine. The study will enroll participants in four groups. Within each group, participants will be randomly assigned to receive the PENNVAX®-GP DNA vaccine/IL-12 DNA adjuvant or placebo. Each group will receive different doses of the vaccine. Enrollment will begin with Group 1, which will receive a low dose of the vaccine and adjuvant. Study staff will review safety data from Group 1 before enrolling people in Groups 2, 3, and 4 at higher doses. Participants in all groups will receive injections at study entry (Day 0) and Months 1, 3, and 6. At each injection visit, participants in Groups 1 and 4 will receive injections in one arm, and participants in Groups 2 and 3 will receive injections in both arms. Groups 1, 2, and 3 will receive ID injections, and Group 4 will receive IM injections. Participants will attend study visits at Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. Visits will include physical examinations, urine collection, blood collection, HIV and risk reduction counseling, and assessments and questionnaires. Some participants may have photographs taken of the injection site (this is optional). Study staff will contact participants at Month 18 for follow-up health monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
94
Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
Sterile Water for Injection, USP. Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Frequency of reactogenicity signs and symptoms
Time frame: Measured through Month 18
Severity of reactogenicity signs and symptoms
Time frame: Measured through Month 18
Magnitude of local injection/EP site pain as measured by a visual analog scale (VAS)
Time frame: Measured through Month 18
Frequency of adverse events (AEs)
Categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products.
Time frame: Measured through Month 18
Measurement of white blood cells
Time frame: Measured through Month 12
Measurement of neutrophils
Time frame: Measured through Month 12
Measurement of lymphocytes
Time frame: Measured through Month 12
Measurement of hemoglobin
Time frame: Measured through Month 12
Measurement of alkaline phosphatase
Time frame: Measured through Month 12
Measurement of platelets
Time frame: Measured through Month 12
Measurement of alanine aminotransferase (ALT)
Time frame: Measured through Month 12
Measurement of aspartate aminotransferase (AST)
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Time frame: Measured through Month 12
Measurement of creatinine
Time frame: Measured through Month 12
Measurement of creatine phosphokinase (CPK)
Time frame: Measured through Month 12
Number of participants with early discontinuation of vaccinations
Time frame: Measured through Month 12
Distribution of responses to questions regarding acceptability of study injection procedures
Time frame: Measured through Month 12
Response rate of CD4+ T-cell responses measured by flow cytometry, to HIV-1-specific peptide pools representing gag, pol, env following the third and fourth vaccinations
Time frame: Measured through Month 12
Response rate of CD8+ T-cell responses measured by flow cytometry, to HIV-1-specific peptide pools representing gag, pol, env following the third and fourth vaccinations
Time frame: Measured through Month 12
Frequency and magnitude of HIV-1 specific binding antibody (Ab) responses as assessed by multiplex assay following the third and fourth vaccinations
Time frame: Measured through Month 12
Neutralizing antibody magnitude and breadth against tier 1 and, if applicable, tier 2 HIV-1 isolates as assessed by area under the magnitude-breadth curves following the third and fourth vaccinations
Time frame: Measured through Month 12
B-cell response rate and magnitude measured by B-cell enzyme-linked immunospot (ELISpot) to quantify Env-specific antibody producing B cells following the third and fourth vaccinations
Time frame: Measured through Month 12