Clincosm LogoSign in Get a demo

TaMoVac II: 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

Sponsor
Muhimbili University of Health and Allied Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01697007
Collaborator
Swedish Institute for Infectious Disease Control (Other), Karolinska Institutet (Other), US Military HIV Research Program (Other), Medical Research Council (Other), National Institute for Medical Research, Tanzania (Other), Ludwig-Maximilians - University of Munich (Other), Imperial College London (Other), Mbeya medical research program (Other), Instituto Nacional de Saúde, Mozambique (Other)
198
Enrollment
3
Locations
3
Arms
30.9
Duration (Months)
66
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: HIVIS DNA vaccine
  • Device: Zetajet
  • Device: Derma Vax Electroporation
  • Biological: Modified Vaccinia Ankara (MVA-CDMR)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
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 Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

Device: Derma Vax Electroporation

Biological: Modified Vaccinia Ankara (MVA-CDMR)
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

Device: Derma Vax Electroporation

Biological: Modified Vaccinia Ankara (MVA-CDMR)

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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

  1. 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

  1. 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]

  2. The presence of HIV-specific binding antibodies and the titer when these are present [Up to week 64 from enrollment]

  3. The presence of neutralizing antibodies and the titer when these are present [Approximately between week 64-68 after enrollment]

  4. 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]

  5. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Nacional de Saude Maputo Mozambique
2 Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania
3 Mbeya Medical Research Programme Mbeya Tanzania

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia Jane Munseri, Prof Eligius Lyamuya, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier:
NCT01697007
Other Study ID Numbers:
  • TaMoVac II
First Posted:
Oct 2, 2012
Last Update Posted:
Jun 29, 2015
Last Verified:
Jun 1, 2015

Study Results

No Results Posted as of Jun 29, 2015