SARS-CoV2 COVID-19
Conditions
Brief 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.
Interventions
BIOLOGICALCOVIGEN C19 0.8 mg ID or Placebo ID
2 doses of COVIGEN C19 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.
BIOLOGICALCOVIGEN C19 2.0 mg IM or Placebo IM
2 doses of COVIGEN C19 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.
BIOLOGICALCOVIGEN C19 4.0 mg IM or Placebo IM
2 doses of COVIGEN C19 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29.
BIOLOGICALCOVIGEN C20 1.0mg vaccine ID
COVIGEN C20 1.0mg ID vaccine will be given at Day 1
Sponsors
Bionet Co., Ltd
Technovalia
Telethon Kids Institute
Institute for Clinical Pathology and Medical Research
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Non-blind staff preparing and administering vaccine or placebo do not participate in any other aspects of the study. Remaining trial staff and participant are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Potential participants must fulfil all of the following inclusion criteria to be eligible to participate in the study: 1. Willing and capable of providing written informed consent prior to the performance of any study-specific procedure. 2. Male or female, ≥18.0 to ≤75. years of age, at the time of consent. 3. The participant must be in good health, as established by pertinent medical history, physical examination and vital signs assessments performed at Screening. 4. Body mass index (BMI) of 18 to 40 kg/m2, inclusive, at Screening. 5. Women of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1, and must agree to remain sexually abstinent, use medically effective contraception (see Section 4.3.10), or have a partner who is sterile or same-sex, from Screening until at least 90 days after the 2nd vaccination (Part A) or the Booster (Part B). a. Females with natural amenorrhea for \<2 years (without an alternative medical cause) and who are not surgically sterile, i.e. tubal ligation, bilateral oophorectomy, or complete hysterectomy will only be considered not to be of childbearing potential if they have a documented follicle-stimulating hormone (FSH) value in the postmenopausal range. 6. Sexually active male participants who are considered sexually fertile must agree to use either a barrier method of contraception from the time of 1st vaccination until at least 90 days after the 2nd vaccination (Part A) or the Booster (Part B), or have a same sex partner, or have a partner who is permanently sterile or unable to become pregnant; 7. Both male and female participants must agree to refrain from sperm and egg donation from the day of the 1st vaccination until at least 90 days after the 2nd vaccination (Part A) or the Booster (Part B).. 8. Clinical safety laboratory evaluations at Screening must be toxicity Grade 0 or 1, or deemed not clinically significant by the Investigator. 9. The participant must agree to refrain from donating blood or plasma during the study for non-study purposes. 10. The participant must agree to have study samples retained for secondary research including exploratory analyses. 11. The participant must be able to attend all scheduled visits and to understand and comply with planned study procedures, in the Investigator's judgement. 12. Part B only: The participant must have completed a primary course (2 doses) of either Comirnaty (Pfizer BioNTech) or Astra Zeneca vaccine and ≥3 months (≥90 days) has elapsed since receipt of dose 2 in the primary course.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of solicited local reactogenicity AEs | Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B) | Percentage of participants with any local reaction (pain, swelling/induration, erythema/redness) for 7 days following each vaccination |
| Frequency of solicited systemic reactogenicity AEs | Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B) | Percentage of participants with any systemic reaction (fever, fatigue, chills, myalgia, arthralgia, headache, nausea/vomiting and diarrhea) for 7 days following each vaccination |
| Frequency of any unsolicited AEs | Day 1 to Day 57 after the 1st vaccination (Part A) or from Day 1 to Day 29 after booster vaccination (Part B). | Percentage of participants with unsolicited AEs up to Day 57 |
| Frequency of any serious adverse events (SAEs) | Day 1 to 12 months after 1st vaccination | Percentage of participants with SAEs from Day 1 to 12 months after 1st vaccination |
| Frequency of any medically attended adverse events (MAAES) | From Day 1 to 12 months after the 1st vaccination | Measured by MedDRA classification, severity score and relatedness. |
| Change in safety laboratory values from baseline | From Day1 to Day 36 in Part A and from Day 1 to Day 8 in Part B | Number of participants with abnormal laboratory values (haematology, chemistry and urinalysis) by FDA toxicity scoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric means of T-cells (spot-forming cells) producing IFNγ, IL-2, or both for S protein specific IFN-γ and IL-2 T-cell responses | At day 1, day 29, and day 57 (Part A) or at Day 1, Day 8, and Day 29 (Part B only) | SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot) |
| GMTs for serum neutralizing antibody response | At day1, day 29 and day 57 (Part A) and Day 1, Day 8, Day 29 (Part B only); | Level of neutralizing antibodies as measured by SARS-CoV-2 Neutralization assay |
| Proportion of participants with significant T-cell responses for S protein specific IFN-γ and IL-2 T-cell responses | At day 57 for Part A and at day 29 for Part B | IL-2 T-cell ELISpot (FluoroSpot) |
| Fold rise of T-cells (spot-forming cells) producing IFNγ, IL-2, or both for S protein specific IFN-γ and IL-2 T-cell responses | At day 57 compared to baseline for Part A and at day 29 compare to baseline for Part B | SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot) |
| GMFR from baseline for serum neutralizing antibody response | At day 57 (Part A) or day 29 (Part B) | Measured by SARS-CoV-2 Neutralization assay |
| Seroconversion rate for serum neutralizing antibody response | At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B | Defined as proportion of participants with a with a ≥4-fold rise |
| GMTs for serum S1- and RBD-specific IgG antibody responses | At day 1, day 29 and day 57 (Part A) and at Day 1, Day 8, Day 29; (Part B only) | SARS-CoV-2 anti-S1 and anti-RBD IgG antibody ELISAs |
| GMFR from baseline for serum S1- and RBD-specific IgG antibody responses | At day 57 (Part A) and at day 29 (Part B) | As measured by ELISA |
| Seroconversion rate serum S1- and RBD-specific IgG antibody responses | At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B | Defined as the proportion of participants with a ≥ 4-fold rise |
Countries
Australia
Outcome results
None listed