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| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1AI068614-18 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| HIV Vaccine Trials Network | NETWORK |
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The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIR-1388, 5×10^4 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
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| VIR-1388, 5×10^5 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
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| VIR-1388, 5×10^6 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
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| Placebo | Placebo Comparator | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-1388 | Biological | VIR-1388 is given by subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs) | Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | 12 months |
| Incidence of solicited local site and systemic reactogenicity events | Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | 14 days after administration of each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of HIV-1 Mfuse1-specific CD4 T cells | As measured by intracellular cytokine staining (ICS) and flow cytometry | 12 months |
| Frequency of HIV-1 Mfuse1-specific CD8 T cells | As measured by intracellular cytokine staining (ICS) and flow cytometry |
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Inclusion Criteria:
In overall good health as determined by medical history, physical exam, and laboratory values
HIV uninfected
CMV seropositive
Willing to use condoms during intercourse for the duration of the study
Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
Childbearing status
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS | Birmingham | Alabama | 35222 | United States | ||
| The Hope Clinic of the Emory Vaccine Center CRS |
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| Placebo | Biological | The HT Diluent Placebo is HT buffer (20 mM histidine, 10% trehalose-dihydrate, pH 7.2) and contains no active ingredient and will be administered by subcutaneous injection |
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| 12 months |
| Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells | As determined by flow cytometry analysis | 12 months |
| Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells | As determined by flow cytometry analysis | 12 months |
| Number of participants with VIR-1388 vector viremia in plasma | Detected by quantitative polymerase chain reaction(qPCR) of plasma | 12 months |
| Number of participants with VIR-1388 vector shedding in saliva and urine | Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine | 12 months |
| Decatur |
| Georgia |
| 30030 |
| United States |
| Beth Israel Deconess Medical Center VCRS | Boston | Massachusetts | 32077 | United States |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh CRS | Pittsburgh | Pennsylvania | 15213 | United States |
| Seattle Vaccine and Prevention CRS | Seattle | Washington | 98104 | United States |
| Setshaba Research Centre CRS | Soshanguve | Gauteng | 0152 | South Africa |
| Perinatal HIV Research Unit | Soweto | Gauteng | 1862 | South Africa |
| Isipingo Clinical Research Site | Isipingo | KwaZulu-Natal | 4110 | South Africa |
| Chatsworth Clinical Research Site | Overport | KwaZulu-Natal | 4092 | South Africa |