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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-06-30

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.

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Detailed Description

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Conditions

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Vaccines HIV Safety Immunogenicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2 injections of DNA administered by 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

Group Type EXPERIMENTAL

HIVIS DNA vaccine

Intervention Type BIOLOGICAL

Zetajet

Intervention Type DEVICE

Modified Vaccinia Ankara (MVA-CDMR)

Intervention Type BIOLOGICAL

2 injections DNA by Zetajet and 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.

Group Type EXPERIMENTAL

HIVIS DNA vaccine

Intervention Type BIOLOGICAL

Zetajet

Intervention Type DEVICE

Derma Vax Electroporation

Intervention Type DEVICE

Modified Vaccinia Ankara (MVA-CDMR)

Intervention Type BIOLOGICAL

1 injection DNA by Zetajet and 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.

Group Type EXPERIMENTAL

HIVIS DNA vaccine

Intervention Type BIOLOGICAL

Zetajet

Intervention Type DEVICE

Derma Vax Electroporation

Intervention Type DEVICE

Modified Vaccinia Ankara (MVA-CDMR)

Intervention Type BIOLOGICAL

Interventions

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HIVIS DNA vaccine

Intervention Type BIOLOGICAL

Zetajet

Intervention Type DEVICE

Derma Vax Electroporation

Intervention Type DEVICE

Modified Vaccinia Ankara (MVA-CDMR)

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes