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| ID | Type | Description | Link |
|---|---|---|---|
| 39136 | Other Identifier | DAIDS DOCUMENT ID |
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Temporarily Closed (Paused) to Accrual
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Department of Health and Human Services | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Treatment: 150 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum, to be administered at Weeks 0 and 8. Followed by: 150 mcg of UVAX-1197 admixed with of 5 mcg of 3M-052-AF + 500 mcg Alum to be administered at Weeks 20 and 32. |
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| Group 2 | Experimental | Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 0 and 8. Followed by: 300 mcg of UVAX-1197 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 20 and 32. |
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| Group 3 | Experimental | Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be at Weeks 0, 8, 20, and 32. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M-052-AF + Alum | Biological | Intramuscular (IM) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of local reactogenicity signs and symptoms | 56 weeks (collected for a minimum of 14 days following receipt of any study vaccine) | |
| Incidence of systemic reactogenicity signs and symptoms | 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 | 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 | 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 | 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 | 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) | Week 22 and Week 34 (2 weeks after the third and fourth vaccinations) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of serum HIV-1 IgG binding antibodies against heterologous Env antigens | Assessed by BAMA | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS (#31788) | Birmingham | Alabama | 35222 | United States | ||
| Columbia P&S CRS (#30329) |
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The trial will begin with enrollment of Group 1. Groups 2 and 3 will open to enrollment concurrently. Enrollment in Group 2 and Group 3 will be randomized.
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| UVAX-1107 | Biological | IM injection |
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| UVAX-1197 | Biological | IM injection |
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| Magnitude of serum HIV-1 IgG binding antibodies against vaccine-matched Env antigens | Assessed by BAMA | 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 | 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 | 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 | 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 | Week 22 and Week 34 (2 weeks after the third and fourth vaccinations) |
Assessed by BAMA |
| 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 | 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 | 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 | 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) | 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 | 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 | Week 22 and Week 34 (2 weeks after the third and fourth vaccinations) |
| Response rate of CD4+ T-cell responses | Measured by intracellular cytokine staining | Week 22 and Week 34 (2 weeks after the third and fourth vaccinations) |
| Magnitude of CD4+ T-cell responses | Measured by intracellular cytokine staining | 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 | Week 22 and Week 34 (2 weeks after the third and fourth vaccinations) |
| Magnitude of CD8+ T-cell responses | Measured by intracellular cytokine staining | 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 | Week 56 (24 weeks after the fourth vaccinations) |
| Magnitude of serum HIV-1 IgG binding antibodies | Assessed by BAMA | Week 56 (24 weeks after the fourth vaccinations) |
| Response rate of serum Ab neutralization | Measured by TZM-bl assay | Week 56 (24 weeks after the fourth vaccinations) |
| Magnitude of serum Ab neutralization | Measured by TZM-bl assay | Week 56 (24 weeks after the fourth vaccinations) |
| Response rate of Env-specific IgG+ B-cells | Measured by flow cytometry analysis | Week 56 (24 weeks after the fourth vaccinations) |
| Magnitude of Env-specific IgG+ B-cells | Measured by flow cytometry analysis | Week 56 (24 weeks after the fourth vaccinations) |
| New York |
| New York |
| 10032 |
| United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Vanderbilt Vaccine (VV) CRS (#30352) | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| C041524 | aluminum sulfate |
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