drugset / Trial / NCT04528641
Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine
Phase 1
Completed
98 enrolled
ReiThera Srl
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.
Timeline
- Start
- 2020-08-10
- Primary completion
- 2021-05-19
- Completion
- 2021-05-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GRAd-COV2 | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | GRAd-COV2 | Vaccine | 1e+11 unknown | Intramuscular |
| Subject | GRAd-COV2 | Vaccine | 2e+11 unknown | Intramuscular |