drugset / Trial / NCT03435874
Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania
Phase 1
Completed
63 enrolled
University of Oxford
Ifakara Health Institute · collabMedical Research Council · collab
RandomizedSequentialQuadruple-blindPrevention
Summary
This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with MVA-RH5 in a heterologous prime-boost regimen. Adults (18-35 years), young children (1-6 years) and infants (6-11 months) will be enrolled in the study. Safety data will be collected for each of the vaccination regimens. The humoral and cellular immune responses generated by each of these regimens will be assessed.
Timeline
- Start
- 2018-04-12
- Primary completion
- 2019-07-11
- Completion
- 2019-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAd63 RH5 | Vaccine | 1e+10 unknown | Intramuscular |
| Subject | ChAd63 RH5 | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | MVA RH5 | Vaccine | 1e+08 unknown | Intramuscular |
| Subject | MVA RH5 | Vaccine | 2e+08 unknown | Intramuscular |