This is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time this combination of study products is 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). Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health. Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Intramuscular (IM) injection
IM injection
IM injection
Alabama CRS (#31788)
Birmingham, Alabama, United States
Columbia P&S CRS (#30329)
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS (#30352)
Nashville, Tennessee, United States
Incidence of local reactogenicity signs and symptoms
Time frame: 56 weeks (collected for a minimum of 14 days following receipt of any study vaccine)
Incidence of systemic reactogenicity signs and symptoms
Time frame: 56 weeks (collected for a minimum of 14 days following receipt of any study vaccine)
Number of participants experiencing Serious Adverse Events (SAEs) leading to early participant withdrawal or permanent discontinuation from the study
Time frame: 108 weeks (throughout the study and for 52 weeks following any receipt of study product)
Number of participants experiencing Medically Attended Adverse Events (MAAEs) leading to early participant withdrawal or permanent discontinuation from the study
Time frame: 108 weeks (throughout the study and for 52 weeks following any receipt of study product)
Number of participants experiencing Adverse Events of Special Interest (AESIs) leading to early participant withdrawal or permanent discontinuation from the study
Time frame: 108 weeks (throughout the study and for 52 weeks following any receipt of study product)
Number of participants experiencing Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation from the study
Time frame: 108 weeks (throughout the study and for 52 weeks following any receipt of study product)
Response rate of serum HIV-1 IgG binding antibodies against vaccine-matched Env antigens
Assessed by binding antibody multiplex assay (BAMA)
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of serum HIV-1 IgG binding antibodies against vaccine-matched Env antigens
Assessed by BAMA
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of serum antibody (Ab) neutralization of tier 1 HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of tier 1 HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of serum HIV-1 IgG binding antibodies against heterologous Env antigens
Assessed by BAMA
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of serum HIV-1 IgG binding antibodies against heterologous Env antigens
Assessed by BAMA
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude-breadth of serum HIV-1 IgG binding antibodies against heterologous Env antigens
Assessed by BAMA
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of heterologous HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous HIV-1 strains
Measured by TZM-bl assay
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of epitope-specific binding
Measured by electron microscopy polyclonal epitope mapping (EMPEM)
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of Env-specific IgG+ B-cells
Measured by flow cytometry analysis
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of Env-specific IgG+ B-cells
Measured by flow cytometry analysis
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
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Response rate of CD4+ T-cell responses
Measured by intracellular cytokine staining
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of CD4+ T-cell responses
Measured by intracellular cytokine staining
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of CD8+ T-cell responses
Measured by intracellular cytokine staining
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Magnitude of CD8+ T-cell responses
Measured by intracellular cytokine staining
Time frame: Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)
Response rate of serum HIV-1 IgG binding antibodies
Assessed by BAMA
Time frame: Week 56 (24 weeks after the fourth vaccinations)
Magnitude of serum HIV-1 IgG binding antibodies
Assessed by BAMA
Time frame: Week 56 (24 weeks after the fourth vaccinations)
Response rate of serum Ab neutralization
Measured by TZM-bl assay
Time frame: Week 56 (24 weeks after the fourth vaccinations)
Magnitude of serum Ab neutralization
Measured by TZM-bl assay
Time frame: Week 56 (24 weeks after the fourth vaccinations)
Response rate of Env-specific IgG+ B-cells
Measured by flow cytometry analysis
Time frame: Week 56 (24 weeks after the fourth vaccinations)
Magnitude of Env-specific IgG+ B-cells
Measured by flow cytometry analysis
Time frame: Week 56 (24 weeks after the fourth vaccinations)