drugset / Trial / NCT04658914
Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
Phase 2
Completed
720 enrolled
Centre for Infectious Disease Research in Zambia
Imperial College London · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabMedical Research Council · collabPATH · collabUniversity of Liverpool · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world. This study will assess protection against rotavirus infection and investigate immune correlates of protection following vaccination with a novel trivalent VP8 subunit rotavirus vaccine used alone or in combination with oral rotavirus vaccine.
Timeline
- Start
- 2021-04-15
- Primary completion
- 2022-08-30
- Completion
- 2023-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rotarix | Vaccine | 1.5 ml | Oral |
| Subject | Trivalent P2-VP8 | Vaccine | 90 ug | Intramuscular |