The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers
Condition: SARS-CoV2 COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial, we are evaluating the safety and tolerability of a new investigational DNA
      vaccine to protect against SARS CoV-2 virus, called COVIGEN, that is developed by a company
      called BioNet-Asia.

      A device will be used to inject the vaccine that does not require the use of a needle
      (needle-free injection made by a company called Pharmajet). For delivery into the skin
      (intradermally) a device called "Tropis" will be used, and for delivery into the muscle
      (intramuscularly) a device called "Stratis" will be used.

      This is a 2 part study

      In Part A vaccine naive participants will be given 2 vaccinations, either two active vaccines
      or two placebo vaccines on Day 1 and Day 29. COVIGEN C19 vaccine will be used in Part A

      In Part B participants who have previously received a 2-dose primary COVID vaccine schedule
      will be given a booster dose of active vaccine. COVIGEN C20 vaccine will be used in Part B.

      Participants in part A and B will be followed up using a combination of on-site and telephone
      visits for assessment of safety and immunogenicity for 12 months from 1st vaccination.
    

Detailed description: 
      Part A Vaccine Naïve participants: The study comprises three dose groups (0.8 mg COVIGEN,
      administered ID, 2 mg COVIGEN, administered IM and 4 mg COVIGEN, administered IM) with 50
      participants in each group. Each group of 50 participants comprises two sub-groups: 25 young
      adults and 25 older adults. Within each group and within each sub-group, participants will be
      randomised 4:1 to receive COVIGEN or placebo in a double-blind fashion.

      Participants will receive 2 study vaccinations, 28 days apart (Day 1 and Day 29). Each dose
      will be divided into 2 injections, with each injection being administered using a needle free
      injection system into the upper arm (left and right) at each visit.

      The study will utilise a sequential dose-escalating design with a 48-hour observation period
      required for sentinel participants prior to the decision to dose escalate. Enrolment of the
      remainder of each age cohort will commence at least 48 hours after the last of the sentinel
      participants has received a vaccine. A Safety Review Committee (SRC) will supervise enrolment
      and monitoring of participant safety throughout the trial

      Part B: Vaccine booster participants: The study comprises a single dose group (1.0mg COVIGEN,
      administered ID) to 50 participants in total, comprising 25 participants who have received a
      primary course of 2 doses of Pfizer BioNTech vaccine and 25 participants who have received a
      primary course of 2 doses of Astra Zeneca vaccine.

      The dose will be divided into 2 injections, with each injection being administered using a
      needle free injection system into the upper arm (left and right) at each visit.

      Participants will be followed up using a combination of on-site and telephone visits for
      assessment of safety and immunogenicity for 12 months from 1st vaccination.
    

Intervention name(s): COVIGEN C19 0.8 mg ID or Placebo ID; COVIGEN C19 2.0 mg IM or Placebo IM; COVIGEN C19 4.0 mg IM or Placebo IM; COVIGEN C20 1.0mg vaccine ID
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 2 doses of COVIGEN C19 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.; 2 doses of COVIGEN C19 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.; 2 doses of COVIGEN C19 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29.; COVIGEN C20 1.0mg ID vaccine will be given at Day 1
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention