VaccinesPhase 2TaMoVac IINCT01697007
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
A Phase 2 study testing HIVIS DNA vaccine, Zetajet and Derma Vax Electroporation in people with Vaccines and HIV, run by Muhimbili University of Health and Allied Sciences at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- HIVIS DNA vaccine, Zetajet and Derma Vax Electroporation
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2012to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- At low risk of HIV infection.
- Verbal assurances for adequate birth control measures.
- Healthy as evidenced by clinical and laboratory measures
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Tanzania2 sites
Muhimbili University of Health and Allied Sciences
Dar es Salaam
Mbeya Medical Research Programme
Mbeya
About this study
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.
- Conditions
- Vaccines, HIV, Safety, Immunogenicity
- Being tested
- HIVIS DNA vaccine, Zetajet, Derma Vax Electroporation, Modified Vaccinia Ankara (MVA-CDMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVIS DNA vaccineBiological
ZetajetDevice
Derma Vax ElectroporationDevice
Modified Vaccinia Ankara (MVA-CDMR)Biological
| Study group | Role | What they receive |
|---|---|---|
| 2 injections of DNA administered by Zetajet | 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 Receives: Biological: HIVIS DNA vaccine; Device: Zetajet; Biological: Modified Vaccinia Ankara (MVA-CDMR) |
| 2 injections DNA by Zetajet and electroporation | 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. Receives: Biological: HIVIS DNA vaccine; Device: Zetajet; Device: Derma Vax Electroporation; Biological: Modified Vaccinia Ankara (MVA-CDMR) |
| 1 injection DNA by Zetajet and electroporation | 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. Receives: Biological: HIVIS DNA vaccine; Device: Zetajet; Device: Derma Vax Electroporation; Biological: Modified Vaccinia Ankara (MVA-CDMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after the last vaccination
Grade 3 or above local and systemic solicited adverse events
Measured: 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
Measured: 2 weeks post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Patricia Jane Munseri, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697007
- Sponsor's protocol ID
- TaMoVac II
- Acronym
- TaMoVac II
- Status last verified
- Jun 2015
- First submitted
- 22 Sep 2012
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30121146
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01697007
- Acronym / sponsor ID
- TaMoVac II / TaMoVac II
- Conditions
- Vaccines, HIV, Safety, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- 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
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 injections of DNA administered by Zetajet | Experimental | Biological: HIVIS DNA vaccine, Device: Zetajet, Biological: Modified Vaccinia Ankara (MVA-CDMR)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 |
| 2 injections DNA by Zetajet and electroporation | Experimental | Biological: HIVIS DNA vaccine, Device: Zetajet, Device: Derma Vax Electroporation, Biological: Modified Vaccinia Ankara (MVA-CDMR)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. |
| 1 injection DNA by Zetajet and electroporation | Experimental | Biological: HIVIS DNA vaccine, Device: Zetajet, Device: Derma Vax Electroporation, Biological: Modified Vaccinia Ankara (MVA-CDMR)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVIS DNA vaccine | Biological | 1 injection DNA by Zetajet and electroporation, 2 injections DNA by Zetajet and electroporation, 2 injections of DNA administered by Zetajet |
| Zetajet | Device | 1 injection DNA by Zetajet and electroporation, 2 injections DNA by Zetajet and electroporation, 2 injections of DNA administered by Zetajet |
| Derma Vax Electroporation | Device | 1 injection DNA by Zetajet and electroporation, 2 injections DNA by Zetajet and electroporation |
| Modified Vaccinia Ankara (MVA-CDMR) | Biological | 1 injection DNA by Zetajet and electroporation, 2 injections DNA by Zetajet and electroporation, 2 injections of DNA administered by Zetajet |
Primary outcome
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
Grade 3 or above local and systemic solicited adverse events
Time frame: Within 2 weeks post each immunization up to week 64 from enrollment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Derived from this study: PubMed 30121146Chissumba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HIVIS DNA vaccine, Zetajet and Derma Vax Electroporation in people with Vaccines and HIV, run by Muhimbili University of Health and Allied Sciences at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tanzania, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.