ChulaCov19 Vaccine in Healthy Adults
Condition: COVID-19 Vaccine; Safety Issues
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open
      label, dose escalation first in human (FIH) study conducted in 2 groups of healthy
      participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll
      elderly adults (elderly) aged 56-75 years (inclusive).

      Phase 2 of this study will be a single centre, the proposed design will be observer-blind,
      placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of
      ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).
    

Detailed description: 
      This study will be conducted as a combined phase 1/2 study in healthy participants.

      The first phase of the study will evaluate the safety, tolerability, and reactogenicity of
      escalating doses (10 µg, 25 µg, and 50 µg) of the ChulaCov19 vaccine, administered
      intramuscularly (IM) according to a repeat vaccination schedule (given 21 days apart) in
      healthy adults aged 18-55 years and in elderly adults aged 56-75 years, up to Visit 10 (Day
      50 ±3).

      The second phase of the study will evaluate the safety, tolerability, and reactogenicity of
      escalating doses of the ChulaCov19 vaccine, administered intramuscularly (IM) according to a
      repeat vaccination schedule (given 21 days apart) in healthy adults aged 18--75 years, up to
      Visit 10 (Day 50 ±3). The study will also evaluate the immunogenicity measured as
      neutralising antibody titre (measured by Micro-viral neutralising test [MicroVNT]) following
      repeat vaccination of escalating doses of the ChulaCov19 vaccine, administered IM according
      to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-75 years, at
      Visit 9 (Day 29 +3).
    

Intervention name(s): ChulaCov19 vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine; Saline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase 1: Group 1 (healthy adults aged 18 to 55 years) and Group 2 (elderlies aged 56 to 75 years) will be enrolled sequentially in an ascending dose fashion (10 µg, 25 µg, 50 µg). Up to 36 eligible healthy volunteers for each of the 2 age groups will be enrolled into 1 of 3 treatment cohorts (12 participants/ cohort). For each cohort, if only 1 participant withdraws prior to the second vaccination, no replacement is deemed necessary. For each cohort, if more than 1 participant withdraws prior to the second vaccination all withdrawn participants will be replaced.
Phase 2: The Phase 2 adult cohorts will include adults between 18 and 59 years of age (inclusive). Participants in the Phase 2 will be enrolled into at least 1 dose level cohort with a vaccination dose of 50 ug which was determined by DSMB and SRPT review and approval of the applicable Phase 1 data. Phase 2 treatment group will consist of participants randomly assigned to active treatment versus placebo in a ratio of 4:1.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: tolerability; reactivity; immunogenicity; healthy adults; healthy elderlies; coronavirus disease 2019; SARS-CoV-2-specific serum neutralising antibody titer; SARS-CoV-2-surrogate viral neutralising antibody; SARS-Cov2 spike protein-binding IgG antibody titer; SARS-Cov2 spike protein-specific CD4+ and CD8+ T-cells responses; IFNγ enzyme-linked immune absorbent spot (ELISpot); SARS-Cov2 spike protein-specific Th1/Th2 polarisation; novel lipid nanoparticles (LNPs)-encapsulated mRNA-based vaccine