Completed

TaMoVac IIA 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

What is being tested

HIVIS DNA vaccine

+ Zetajet

+ Modified Vaccinia Ankara (MVA-CDMR)

BiologicalDevice

Who is being recruted

From 18 to 40 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Phase 2

Interventional

Study Start: November 2012

See protocol details

Summary

Principal SponsorMuhimbili University of Health and Allied Sciences

Last updated: June 29, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01697007

Principal SponsorMuhimbili University of Health and Allied Sciences

Last updated: June 29, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

198 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

Able to give informed consent

At low risk of HIV infection

Basic abilities to read and write

Have a negative antigen/antibody ELISA for HIV infection

Show More Criteria

11 exclusion criteria prevent from participating

A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention

Active tuberculosis

At risk of HIV infection

Autoimmune disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Instituto Nacional de Saude

Maputo, MozambiqueOpen Instituto Nacional de Saude in Google Maps

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Mbeya Medical Research Programme

Mbeya, Tanzania

Completed3 Study Centers