Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID 19 Vaccine
  • Safety Issues
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Healthy adults (age 18 to 55 years) and elderlies (age 65 to 75 years) will be enrolled sequentially in an ascending dose fashion (10 µg, 25 µg, 50 µg, and 100 µg).Masking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

This study will be conducted in 2 phases. The first phase of the study will evaluate the safety, tolerability and the reactogenicity of escalating doses (10 µg, 25 µg, 50 µg, and 100 µg) of the ChulaCov19 messenger ribonucleic acid (mRNA) vaccine, administered IM according to a repeat vaccination sc...

This study will be conducted in 2 phases. The first phase of the study will evaluate the safety, tolerability and the reactogenicity of escalating doses (10 µg, 25 µg, 50 µg, and 100 µg) of the ChulaCov19 messenger ribonucleic acid (mRNA) vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 65-75 years, up to Day 50. For each dose, there will be 12 participants. There will be a total of 8 arms (4 arms for healthy adults aged 18-55 years and 4 arms for the elderlies). There will be a total of 96 participants. The second phase of the study (if DSMB approves for the study to proceed to the next phase) will evaluate the immunogenicity measured as neutralising antibody titer (measured by MicroVNT [Micro-viral neutralising test]) following repeat vaccination of escalating doses of the ChulaCov19 mRNA vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 65-75 years, at Day 29 (7 days after the second vaccination). Each treatment group will consist of participants randomly assigned to active treatment versus placebo in a ratio of 4:1 per dose cohort. The participants, the care providers, the PI(s), and the outcome assessors will be blinded to the treatment assignment of the participants. Two different doses will be evaluated in the healthy adults (total 4 arms, including placebo). Two different doses will be investigated in the elderlies (total 4 arms, including placebo). There will be a total of 600 participants (120 participants per dose; 30 participants for placebo).

Tracking Information

NCT #
NCT04566276
Collaborators
  • Center of Excellence in Vaccine Research and Development, Chulalongkorn University
  • Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine, Mahidol University
  • Chula Vaccine Research Center (ChulaVRC), Faculty of Medicine, Chulalongkorn University
  • National Vaccine Institute (NVI), Thailand
  • National Research Council of Thailand
  • C2F Chulalongkorn University, Faculty of Medicine, Chulalongkorn University
Investigators
Study Director: Kiat Ruxrungtham, MD Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University