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
1 other identifier
interventional
198
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 29, 2015
June 1, 2015
2.1 years
September 22, 2012
June 26, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (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 Outcomes (5)
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
- +2 more other outcomes
Study Arms (3)
2 injections of DNA administered by Zetajet
EXPERIMENTALThis 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
2 injections DNA by Zetajet and electroporation
EXPERIMENTALThis 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.
1 injection DNA by Zetajet and electroporation
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Muhimbili University of Health and Allied Scienceslead
- Swedish Institute for Infectious Disease Controlcollaborator
- Karolinska Institutetcollaborator
- US Military HIV Research Programcollaborator
- Medical Research Councilcollaborator
- National Institute for Medical Research, Tanzaniacollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- Imperial College Londoncollaborator
- Mbeya medical research programcollaborator
- Instituto Nacional de Saúde, Mozambiquecollaborator
Study Sites (3)
Instituto Nacional de Saude
Maputo, Mozambique
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Mbeya Medical Research Programme
Mbeya, Tanzania
Related Publications (1)
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.
PMID: 30121146DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Eligius Lyamuya
Study Record Dates
First Submitted
September 22, 2012
First Posted
October 2, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
June 29, 2015
Record last verified: 2015-06