Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine
Summary
A multicenter, randomized, double-blind, active comparator, non-inferiority, multicenter IIb clinical trial to compare the safety and immunogenicity of two dose levels of the MCTI CIMATEC HDT RNA Vaccine against two authorized COVID-19 vaccines in Brazil (Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca) in 300 participants. Each vaccine will be provided as a single booster vaccine in adults aged 18 to 65 years previously immunized with both vaccines (Comirnaty - Pfizer and Covishield - Oxford/Astrazen). The investigational product MCTI C HDT will be administered in one of the two doses evaluated (5µg and 10 µg). The comparator products will be Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca. The primary outcomes will be the number of participants with a 2-fold increase or more on average by titers of neutralizing D64G pseudovirus strain (pNT50) and comparison of titers generated by 5µg and 10µg doses of MCTI-CIMATEC-HDT RNA Vaccine.
Timeline
- Start
- 2023-01
- Primary completion
- 2023-03
- Completion
- 2023-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AZD1222 | Vaccine | — | Intramuscular |
| Comparator | BNT162b2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | RNA MCTI CIMATEC HDT | Vaccine | 5 ug | Intramuscular |
| Subject | RNA MCTI CIMATEC HDT | Vaccine | 10 ug | Intramuscular |