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| Name | Class |
|---|---|
| Swedish Institute for Infectious Disease Control | OTHER |
| Karolinska Institutet | OTHER |
| US Military HIV Research Program | NETWORK |
| Medical Research Council |
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Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 injections of DNA administered by Zetajet | Experimental | This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml |
|
| 2 injections DNA by Zetajet and electroporation | Experimental | This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml followed by electroporation using the Derma Vax device. |
|
| 1 injection DNA by Zetajet and electroporation | Experimental | This arm will receive 600 micrograms of HIVIS DNA given in 1 injection using the Zetajet device the injection will comprise of 0.1 ml at a concentration of 6mg/ml followed by electroporation using the Derma Vax device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIVIS DNA vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline | 2 weeks after the last vaccination | |
| Grade 3 or above local and systemic solicited adverse events | Within 2 weeks post each immunization up to week 64 from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining | 2 weeks post last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Any grade of adverse event that results in a clinical decision to discontinue further immunizations. | After receiving the first immunization until 64 weeks from enrollment | |
| The presence of HIV-specific binding antibodies and the titer when these are present | Up to week 64 from enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Saude | Maputo | Mozambique | ||||
| Muhimbili University of Health and Allied Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30121146 | Derived | Chissumba RM, Luciano A, Namalango E, Bauer A, Bhatt N, Wahren B, Nilsson C, Geldmacher C, Scarlatti G, Jani I, Kestens L; TaMoVac II group. Regulatory T cell abundance and activation status before and after priming with HIVIS-DNA and boosting with MVA-HIV/rgp140/GLA-AF may impact the magnitude of the vaccine-induced immune responses. Immunobiology. 2018 Dec;223(12):792-801. doi: 10.1016/j.imbio.2018.08.006. Epub 2018 Aug 12. |
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| OTHER_GOV |
| National Institute for Medical Research, Tanzania | OTHER_GOV |
| Ludwig-Maximilians - University of Munich | OTHER |
| Imperial College London | OTHER |
| Mbeya medical research program | UNKNOWN |
| Instituto Nacional de Saúde, Mozambique | OTHER_GOV |
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| Zetajet | Device |
|
| Derma Vax Electroporation | Device |
|
| Modified Vaccinia Ankara (MVA-CDMR) | Biological |
|
| The presence of neutralizing antibodies and the titer when these are present | Approximately between week 64-68 after enrollment |
| The magnitude of interferon gamma ELISpot responses measured by the number of spot forming cells per million PBMCs in response to pools of HIV-peptides in the assay | 2 weeks post the last vaccination |
| Any grade of adverse event that occurs in a participant that has received at lease one immunization | After the first immunization up to 64 weeks |
| Dar es Salaam |
| Tanzania |
| Mbeya Medical Research Programme | Mbeya | Tanzania |
| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
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