NCT05542693

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

Phase IIb, Randomized, Double-blind, Non-inferior, Multicenter Study to Evaluate the Safety and Immunogenicity of the Self-replicating Nanoparticle Carrier Replicon RNA Carrier (repRNA) Vaccine in Adults 18 to 65 Years of Age

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	RNA MCTI CIMATEC HDT 5µg	Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
BIOLOGICAL	RNA MCTI CIMATEC HDT 10µg	Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
BIOLOGICAL	Covishield® - AstraZeneca	Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)
BIOLOGICAL	Comirnaty® - Pfizer	Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-03-01
• Completion: 2023-09-01
• First posted: 2022-09-15
• Last updated: 2022-09-15