Cochrane COVID-19 Study Register
CTRI/2020/07/026352

Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects

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

Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects

Cadila Healthcare Ltd
Trial registry record
No Results
Inclusion criteria: 1.Healthy male and non-pregnant, non-lactating female subjects between 18-55 years of age (both inclusive) 2.Body weight > 50 kg for male and > 45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive) 3.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study 4.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: haematology, serum biochemistry, urinalysis, and serology 5.Subjects who can comply with trial procedures and who are available for the duration of follow up 6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of last study vaccine. For Phase II:- 1.Healthy subject of either gender 12 years of age 2.Informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject) 3.Adult subjects or parents of paediatric subjects literate enough to fill the diary card 4.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit and males will agree to use contraception. Intervention: Intervention1: nCov Vaccine: 1)Dose:-0.1 ml.(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal Control Intervention1: Placebo: 1)Dose:-0.1 ml.(2)Frequency:-single time at day 0(3)Route: Intradermal Primary outcome: Phase I:-To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects. Phase II:-To evaluate the immunogenicity of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo.Timepoint: Phase I: Day 0 and Day 84 Phase II: Day 0 and Day 224