HIV, Immunogenicity, Safety, Vaccines
Conditions
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.
Interventions
BIOLOGICALHIVIS DNA vaccine
DEVICEZetajet
DEVICEDerma Vax Electroporation
BIOLOGICALModified Vaccinia Ankara (MVA-CDMR)
Sponsors
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
Muhimbili University of Health and Allied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The presence of neutralizing antibodies and the titer when these are present | Approximately between week 64-68 after enrollment |
| 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 |
| 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 |
| 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 |
Countries
Mozambique, Tanzania
Outcome results
None listed