Clinical trial NCT01697007: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaccines
HIV
Safety
Immunogenicity
Lead sponsor: Muhimbili University of Health and Allied Sciences
Sponsor class: OTHER
Collaborators: name: Swedish Institute for Infectious Disease Control
name: Karolinska Institutet
name: US Military HIV Research Program
name: Medical Research Council
name: National Institute for Medical Research, Tanzania
name: Ludwig-Maximilians - University of Munich
name: Imperial College London
name: Mbeya medical research program
name: Instituto Nacional de Saúde, Mozambique
First posted: 2012-10-02
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
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
timeFrame: 2 weeks after the last vaccination
measure: Grade 3 or above local and systemic solicited adverse events
timeFrame: Within 2 weeks post each immunization up to week 64 from enrollment
Secondary outcomes:
measure: The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining
timeFrame: 2 weeks post last vaccination
Other outcomes:
measure: Any grade of adverse event that results in a clinical decision to discontinue further immunizations.
timeFrame: After receiving the first immunization until 64 weeks from enrollment
measure: The presence of HIV-specific binding antibodies and the titer when these are present
timeFrame: Up to week 64 from enrollment
measure: The presence of neutralizing antibodies and the titer when these are present
timeFrame: Approximately between week 64-68 after enrollment
measure: 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
timeFrame: 2 weeks post the last vaccination
measure: Any grade of adverse event that occurs in a participant that has received at lease one immunization
timeFrame: After the first immunization up to 64 weeks
Locations:
city: Maputo
country: Mozambique
facility: Instituto Nacional de Saude
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
city: Mbeya
country: Tanzania
facility: Mbeya Medical Research Programme
Study officials:
References:
citation: 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.