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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Muhimbili University of Health and Allied Sciences
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Patricia Jane Munseri, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier:
NCT01697007
First received: September 22, 2012
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Vaccines
HIV
Safety
Immunogenicity
Biological: HIVIS DNA vaccine
Device: Zetajet
Device: Derma Vax Electroporation
Biological: Modified Vaccinia Ankara (MVA-CDMR)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Muhimbili University of Health and Allied Sciences:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 weeks after the last vaccination ] [ Designated as safety issue: No ]
  • Grade 3 or above local and systemic solicited adverse events [ Time Frame: Within 2 weeks post each immunization up to week 64 from enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining [ Time Frame: 2 weeks post last vaccination ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Any grade of adverse event that results in a clinical decision to discontinue further immunizations. [ Time Frame: After receiving the first immunization until 64 weeks from enrollment ] [ Designated as safety issue: Yes ]
  • The presence of HIV-specific binding antibodies and the titer when these are present [ Time Frame: Up to week 64 from enrollment ] [ Designated as safety issue: No ]
  • The presence of neutralizing antibodies and the titer when these are present [ Time Frame: Approximately between week 64-68 after enrollment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 weeks post the last vaccination ] [ Designated as safety issue: No ]
  • Any grade of adverse event that occurs in a participant that has received at lease one immunization [ Time Frame: After the first immunization up to 64 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 198
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697007

Contacts
Contact: Eligius Lyamuya, MD, MMED, PHD +255786172528 elyamuya@yahoo.com

Locations
Mozambique
Instituto Nacional de Saude Recruiting
Maputo, Mozambique
Principal Investigator: Ilesh Jani, MD, PhD         
Sub-Investigator: Edna Viegas, MD         
Tanzania
Muhimbili University of Health and Allied Sciences Recruiting
Dar es Salaam, Tanzania
Contact: Muhammad Bakari, MD,MMed, PhD    +255754387328    drbakari@yahoo.com   
Contact: Patricia Munseri, MD, MMed    +255754562784    patricia.munseri@ki.se   
Principal Investigator: Muhammad Bakari, MD, MMED, PhD         
Sub-Investigator: Patricia Munseri, MD, MMED         
Mbeya Medical Research Programme Recruiting
Mbeya, Tanzania
Principal Investigator: Leonard Maboko, MD, MSc         
Sub-Investigator: Philipp Mann, MD         
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
  More Information

No publications provided

Responsible Party: Patricia Jane Munseri, Prof Eligius Lyamuya, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT01697007     History of Changes
Other Study ID Numbers: TaMoVac II
Study First Received: September 22, 2012
Last Updated: April 19, 2013
Health Authority: Tanzania: Food & Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014