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)

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.

Study Overview

• Status: Completed
• Conditions: HIV; Safety; Immunogenicity; Vaccines
• Intervention / Treatment: Biological: HIVIS DNA vaccine; Device: Zetajet; Biological: Modified Vaccinia Ankara (MVA-CDMR); Device: Derma Vax Electroporation

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mozambique
  • Maputo, Mozambique
    • Instituto Nacional de Saúde
• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences
  • Mbeya, Tanzania
    • Mbeya Medical Research Programme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: HIVIS DNA vaccine; Device: Zetajet; Biological: Modified Vaccinia Ankara (MVA-CDMR)
Experimental: 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.	Biological: HIVIS DNA vaccine; Device: Zetajet; Biological: Modified Vaccinia Ankara (MVA-CDMR); Device: Derma Vax Electroporation
Experimental: 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.	Biological: HIVIS DNA vaccine; Device: Zetajet; Biological: Modified Vaccinia Ankara (MVA-CDMR); Device: Derma Vax Electroporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Any grade of adverse event that results in a clinical decision to discontinue further immunizations.	After receiving the first immunization until 64 weeks from enrollment
The presence of HIV-specific binding antibodies and the titer when these are present	Up to week 64 from enrollment
The presence of neutralizing antibodies and the titer when these are present	Approximately between week 64-68 after enrollment
The magnitude of interferon gamma ELISpot responses measured by the number of spot forming cells per million PBMCs in response to pools of HIV-peptides in the assay	2 weeks post the last vaccination
Any grade of adverse event that occurs in a participant that has received at lease one immunization	After the first immunization up to 64 weeks

Collaborators and Investigators

• Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Karolinska Institutet; Imperial College London; Medical Research Council; Ludwig-Maximilians - University of Munich; US Military HIV Research Program; Instituto Nacional de Saúde, Mozambique; Swedish Institute for Infectious Disease Control; National Institute for Medical Research, Tanzania; Mbeya medical research program

Publications and helpful links

General Publications

• Chissumba RM, Luciano A, Namalango E, Bauer A, Bhatt N, Wahren B, Nilsson C, Geldmacher C, Scarlatti G, Jani I, Kestens L; TaMoVac II group. Regulatory T cell abundance and activation status before and after priming with HIVIS-DNA and boosting with MVA-HIV/rgp140/GLA-AF may impact the magnitude of the vaccine-induced immune responses. Immunobiology. 2018 Dec;223(12):792-801. doi: 10.1016/j.imbio.2018.08.006. Epub 2018 Aug 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 22, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 26, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: TaMoVac II