This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Intramuscular (IM) injection
IM injection
University of Alabama Medical Center (Site ID: 31788)
Birmingham, Alabama, United States
The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440)
Decatur, Georgia, United States
Brigham and Women's Hospital (Site ID: 30007)
Boston, Massachusetts, United States
Columbia P&S CRS (Site ID: 30329)
New York, New York, United States
University of Rochester Medical Center (Site ID: 31467)
Rochester, New York, United States
University of Pittsburgh (Site ID: 1001)
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center (Site ID: 30352)
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS (Site ID: 30331)
Seattle, Washington, United States
Incidence of local reactogenicity signs and symptoms
Time frame: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Incidence of systemic reactogenicity signs and symptoms
Time frame: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Number of participants experiencing Serious adverse events (SAEs)
Time frame: Baseline through Month 22
Number of participants experiencing medically attended adverse events (MAAEs)
Time frame: Baseline through Month 22
Number of participants experiencing adverse events of special interest (AESIs)
Time frame: Baseline through Month 22
Number of participants experiencing adverse events (AEs) leading to early participant withdrawal or permanent discontinuation will be collected throughout the study
Time frame: Baseline through Month 22
Response rate of V3G-specific IgG+ B cells, as assessed by flow cytometry
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by BAMA
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of serum antibody (Ab) neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Frequency of V3G bnAb lineage sequences, as measured by B-cell receptor (BCR) single-cell sequencing of V3G-specific IgG+ B cells
Time frame: Baseline though Month 22
Epitope-specific response rates, as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Time frame: At week 42 (2 weeks after the fourth vaccinations)
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