drugset / 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
Phase 2
Completed
198 enrolled
Muhimbili University of Health and Allied Sciences
Imperial College London · collabInstituto Nacional de Saúde, Mozambique · collabKarolinska Institutet · collabLudwig-Maximilians - University of Munich · collabMbeya medical research program · collabMedical Research Council · collabNational Institute for Medical Research, Tanzania · collabSwedish Institute for Infectious Disease Control · collabUS Military HIV Research Program · collab
RandomizedParallel-groupQuadruple-blind
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.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-12
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HIVIS DNA vaccine | Unknown | 600 ug | Other |
| Subject | MVA-CDMR | Unknown | — | Intramuscular |