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Cochrane COVID-19 Study Register
Study record
CTRI/2021/04/032688First Published: 2021 Aug 3Updated Date: 2021 Aug 3

Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Prevention
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
Reference record

Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants

Gennova Biopharmaceuticals Limited
Trial registry record
No Results
INTERVENTION: Intervention1: HGCO19 (COVID-19 vaccine): Novel mRNA-based candidate vaccine candidate, using Spike (S)-protein of the virus as antigen. HGCO19 will be administered IM at day 1 and day 29. Control Intervention1: Placebo: Two doses of 0.5 ml of placebo (buffer), administered Intramuscularly at 4-weeks apart. CONDITION: PRIMARY OUTCOME: 1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. ; 2. Occurrence, severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. ; 3. Occurrence, severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. ; 4. Occurrence of SAE at any time during study participation. ; 5. Changes in safety assessments including laboratory parameters and vital signs from baseline. Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study. SECONDARY OUTCOME: 1. Geometric mean titer (GMT) as measured by IgG-ELISA to SARS-CoV-2 Spike protein and against the RBD of Spike protein at Day 57 (28 days post Dose 2). ; 2. Geometric mean fold rise (GMFR) in SARS CoV-2 Spike protein-specific binding antibody (IgG) levels and in RBD of Spike protein IgG levels from baseline at Day 57. ; Timepoint: At day 57. Exploratory Outcome: ; 7. Number of subjects with laboratory confirmed COVID-19 infection during study participation. Timepoint: Throughout the study duration. Exploratory Outcomes: ; 1. GMT of SARS-CoV-2 specific serum neutralizing antibody levels as measured by pseudovirus/ surrogate virus neutralization assay at Day 29 (before Dose 2), Day 57, Day 119 and Day 209. ; 2. GMT of SARS-CoV-2 specific serum neutralizing antibody levels as measured by live virus SARS-CoV-2 neutralization assay [Plaque Reduction Neutralization Test (PRNT)] at Day 29, Day 57, Day 119 and Day 209. ; Timepoint: At day 29, day 57, day 119 and day 209. Exploratory Outcomes: ; 3. Relationship (correlation analysis) between SARS-CoV-2 neutralizing antibody and S-protein and RBD of S-protein IgG titers at Days 29, 57, 119, and 209. ; 4. GMT as measured by IgG-ELISA to SARS-CoV-2 S-protein and against the RBD of S-protein at Days 29, 119 and 209. ; 5. GMT as measured by IgM-ELISA to SARS-CoV-2 S-protein at Days 29, 57, 119, and 209. ; 6. SARS-CoV-2 Spike protein specific T-cell responses as measured by flow cytometry at Days 29, 57, 119, and 209. ; Timepoint: At day 29, day 57, day 119 and day 209. INCLUSION CRITERIA: Applicable for both phases of study: 1. Male and female subjects aged between 18 to 70 years (Phase I) / 18 to 75 years (Phase II) (both inclusive) at randomization. 2. Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive for antibodies against SARS-CoV-2