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 (TaMoVac II)

Muhimbili University of Health and Allied Sciences (MUHAS)

Status and phase: Completed; Phase 2

Conditions: HIV; Vaccines; Immunogenicity; Safety

Treatments: Biological: HIVIS DNA vaccine; Biological: Modified Vaccinia Ankara (MVA-CDMR); Device: Derma Vax Electroporation; Device: Zetajet

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01697007

TaMoVac II

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

198 participants in 3 patient groups

2 injections of DNA administered by Zetajet

Experimental group

Description:

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

Treatment:

Biological: HIVIS DNA vaccine

Biological: Modified Vaccinia Ankara (MVA-CDMR)

Device: Zetajet

2 injections DNA by Zetajet and electroporation

Experimental group

Description:

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.

Treatment:

Biological: HIVIS DNA vaccine

Biological: Modified Vaccinia Ankara (MVA-CDMR)

Device: Derma Vax Electroporation

Device: Zetajet

1 injection DNA by Zetajet and electroporation

Experimental group

Description:

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.

Treatment:

Biological: HIVIS DNA vaccine

Biological: Modified Vaccinia Ankara (MVA-CDMR)

Device: Derma Vax Electroporation

Device: Zetajet