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
Phase 2
Completed
- Conditions
- ImmunogenicityVaccinesHIVSafety
- Interventions
- Biological: HIVIS DNA vaccineDevice: ZetajetDevice: Derma Vax ElectroporationBiological: Modified Vaccinia Ankara (MVA-CDMR)
- Registration Number
- NCT01697007
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 injections DNA by Zetajet and electroporation Derma Vax Electroporation 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. 2 injections of DNA administered by Zetajet HIVIS DNA vaccine 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 of DNA administered by Zetajet Zetajet 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 1 injection DNA by Zetajet and electroporation Derma Vax Electroporation 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. 2 injections DNA by Zetajet and electroporation HIVIS DNA vaccine 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. 2 injections DNA by Zetajet and electroporation Zetajet 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 Modified Vaccinia Ankara (MVA-CDMR) 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. 2 injections of DNA administered by Zetajet Modified Vaccinia Ankara (MVA-CDMR) 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 Modified Vaccinia Ankara (MVA-CDMR) 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 HIVIS DNA vaccine 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. 1 injection DNA by Zetajet and electroporation Zetajet 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (3)
Muhimbili University of Health and Allied Sciences
🇹🇿Dar es Salaam, Tanzania
Mbeya Medical Research Programme
🇹🇿Mbeya, Tanzania
Instituto Nacional de Saude
🇲🇿Maputo, Mozambique