A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

Conditions
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Vaccines, HIV, Safety, Immunogenicity

Intervention / Treatment
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* Biological: HIVIS DNA vaccine
* Device: Zetajet
* Device: Derma Vax Electroporation
* Biological: Modified Vaccinia Ankara (MVA-CDMR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to undergo counselling and HIV testing. Have a negative antigen/antibody ELISA for HIV infection. Able to give informed consent. Basic abilities to read and write. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test. Resident of the region where the study is taking place. At low risk of HIV infection. Verbal assurances for adequate birth control measures. Healthy as evidenced by clinical and laboratory measures Exclusion Criteria: At risk of HIV infection. Active tuberculosis. A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention. Autoimmune disease. Hives and severe eczema. Substance abuse problems. History of grand-mal epilepsy. Received blood or blood products or immunoglobulins in the past 3 months. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy. Use of experimental therapeutic agents within 30 days of study entry. History of cardiac disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 injections of DNA administered by Zetajet<br>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 | Biological: HIVIS DNA vaccine<br> <br> Device: Zetajet<br> <br> Biological: Modified Vaccinia Ankara (MVA-CDMR)<br> <br> |
| Experimental: 2 injections DNA by Zetajet and electroporation<br>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. | Biological: HIVIS DNA vaccine<br> <br> Device: Zetajet<br> <br> Device: Derma Vax Electroporation<br> <br> Biological: Modified Vaccinia Ankara (MVA-CDMR)<br> <br> |
| Experimental: 1 injection DNA by Zetajet and electroporation<br>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. | Biological: HIVIS DNA vaccine<br> <br> Device: Zetajet<br> <br> Device: Derma Vax Electroporation<br> <br> Biological: Modified Vaccinia Ankara (MVA-CDMR)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |