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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04742842




Registration number
NCT04742842
Ethics application status
Date submitted
28/01/2021
Date registered
8/02/2021

Titles & IDs
Public title
The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers
Scientific title
A Phase I, Double-blind, Dose-ranging, Randomised, Placebo-controlled Trial to Study the Safety and Immunogenicity of a DNA-based Vaccine Against COVID-19 (COVIGEN) in Healthy Participants Aged 18 to 75 Years Old
Secondary ID [1] 0 0
COV101
Universal Trial Number (UTN)
Trial acronym
COVALIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV2 COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - COVIGEN C19 0.8 mg ID or Placebo ID
Treatment: Other - COVIGEN C19 2.0 mg IM or Placebo IM
Treatment: Other - COVIGEN C19 4.0 mg IM or Placebo IM
Treatment: Other - COVIGEN C20 1.0mg vaccine ID

Experimental: Part A: Arm1 (COVIGEN (C19) 0.8 mg ID or Placebo ID) - Participants will be randomized to receive either COVIGEN C19 (0.8 mg) given by ID (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart.

Experimental: Part A: Arm2 (COVIGEN (C19) 2.0 mg IM or Placebo IM) - Participants will be randomized to receive either COVIGEN C19 (2 mg) given by IM (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart.

Experimental: Part A; Arm 3 (COVIGEN (C19) 4.0 mg IM or Placebo IM) - Participants will be randomized to receive either COVIGEN C19 (4 mg) given by IM (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart

Experimental: Part B: Arm 1 (COVIGEN (C20) 1.0 mg ID) in BNT162b2 primed participants - Participants in Part B who have received a 2 dose primary course of Pfizer BNT162b2 vaccine will receive COVIGEN C20 (1mg) vaccine given by ID (n=25)

Experimental: Part B: Arm 2 (COVIGEN (C20) 1.0 mg ID) in ChAdOx1-S primed participants - Participants in Part B who have received a 2 dose primary course of Astra Zeneca ChAdOx1-S vaccine will receive COVIGEN C20 (1mg) vaccine given by ID (n=25)


Treatment: Other: COVIGEN 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.

Treatment: Other: COVIGEN 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.

Treatment: Other: COVIGEN 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.

Treatment: Other: COVIGEN C20 1.0mg vaccine ID
COVIGEN C20 1.0mg ID vaccine will be given at Day 1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of solicited local reactogenicity AEs
Timepoint [1] 0 0
Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Primary outcome [2] 0 0
Frequency of solicited systemic reactogenicity AEs
Timepoint [2] 0 0
Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Primary outcome [3] 0 0
Frequency of any unsolicited AEs
Timepoint [3] 0 0
Day 1 to Day 57 after the 1st vaccination (Part A) or from Day 1 to Day 29 after booster vaccination (Part B).
Primary outcome [4] 0 0
Frequency of any serious adverse events (SAEs)
Timepoint [4] 0 0
Day 1 to 12 months after 1st vaccination
Primary outcome [5] 0 0
Frequency of any medically attended adverse events (MAAES)
Timepoint [5] 0 0
From Day 1 to 12 months after the 1st vaccination
Primary outcome [6] 0 0
Change in safety laboratory values from baseline
Timepoint [6] 0 0
From Day1 to Day 36 in Part A and from Day 1 to Day 8 in Part B
Secondary outcome [1] 0 0
GMTs for serum neutralizing antibody response
Timepoint [1] 0 0
At day1, day 29 and day 57 (Part A) and Day 1, Day 8, Day 29 (Part B only);
Secondary outcome [2] 0 0
GMFR from baseline for serum neutralizing antibody response
Timepoint [2] 0 0
At day 57 (Part A) or day 29 (Part B)
Secondary outcome [3] 0 0
Seroconversion rate for serum neutralizing antibody response
Timepoint [3] 0 0
At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
Secondary outcome [4] 0 0
GMTs for serum S1- and RBD-specific IgG antibody responses
Timepoint [4] 0 0
At day 1, day 29 and day 57 (Part A) and at Day 1, Day 8, Day 29; (Part B only)
Secondary outcome [5] 0 0
GMFR from baseline for serum S1- and RBD-specific IgG antibody responses
Timepoint [5] 0 0
At day 57 (Part A) and at day 29 (Part B)
Secondary outcome [6] 0 0
Seroconversion rate serum S1- and RBD-specific IgG antibody responses
Timepoint [6] 0 0
At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
Secondary outcome [7] 0 0
Geometric means of T-cells (spot-forming cells) producing IFN?, IL-2, or both for S protein specific IFN-? and IL-2 T-cell responses
Timepoint [7] 0 0
At day 1, day 29, and day 57 (Part A) or at Day 1, Day 8, and Day 29 (Part B only)
Secondary outcome [8] 0 0
Fold rise of T-cells (spot-forming cells) producing IFN?, IL-2, or both for S protein specific IFN-? and IL-2 T-cell responses
Timepoint [8] 0 0
At day 57 compared to baseline for Part A and at day 29 compare to baseline for Part B
Secondary outcome [9] 0 0
Proportion of participants with significant T-cell responses for S protein specific IFN-? and IL-2 T-cell responses
Timepoint [9] 0 0
At day 57 for Part A and at day 29 for Part B

Eligibility
Key inclusion criteria
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 exclusion criteria apply, the potential participant will not be permitted to participate in the study:

1. Female participant who is breastfeeding or intends to become pregnant from Screening until at least 90 days after the 2nd vaccination (Part A) or at least 90 days after booster vaccination (Part B).
2. History of any major (per Investigator's discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, asthma (with the exception of history of resolved childhood asthma), immunological and autoimmune diseases or any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
3. Chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to Screening. Intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted.
4. History of any haematological malignancy or active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated). Active is defined as having received treatment within the past 5 years.
5. History of demyelinating disease or Guillain Barre syndrome.
6. Eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm).
7. History of blood dyscrasia or significant disorder of coagulation that, in the opinion of the Investigator, contraindicates IM injection (Part A only).
8. History of known or suspected hypersensitivity or any severe allergic reaction including anaphylaxis, generalised urticaria, angioedema, and other significant reaction to Kanamycin or any vaccine component,.
9. Presence of active viral or bacterial infection, with or without fever (oral temperature =37.8 °C) at Screening or within 72 hours prior to each vaccination, if determined by the Investigator to be of clinical significance (enrolment [provided Screening period does not exceed 30 days] or dosing may be delayed for full recovery if acceptable to the Investigator).
10. Positive serological test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or HIV (Type 1 or 2) antibody at Screening.
11. Known current or previous laboratory confirmed SARS-CoV-2 infection/COVID 19, or positive for SARS-CoV-2 infection, either by SARS CoV 2-specific IgG antibody (Part A only) or RT-PCR, at Screening.
12. Suspected SARS-CoV-2 infection/COVID-19, including individuals who are required to self-isolate.
13. Individuals currently working in occupations with high risk of exposure to SARS CoV-2, e.g. healthcare workers in direct care of COVID-19 patients, emergency responders or front-line workers.
14. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to the study or planned receipt of any other SARS-CoV-2 or other experimental vaccine within 57 days of receipt of the 1st study vaccination (Part A only).
15. Receipt of any other experimental coronavirus vaccine at any time prior to the study or planned receipt of any other SARS-CoV-2 or other experimental vaccine within 29 days of receipt of the booster vaccination (Part B only).
16. Participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to Screening, or are taking part in a non medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
17. Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination.
18. Received or plans to receive an inactivated vaccine within 2 weeks before or after each study vaccination (including influenza vaccines).
19. Received immunoglobulins and/or any blood or blood products within 3 months before the 1st vaccination (Part A) or before the booster vaccination (Part B) or plans to receive any blood or blood products at any time during the study.
20. Has a history of alcohol abuse, or other drug abuse assessed as a dependency problem by the Investigator within 6 months before the 1st vaccination (Part A) or before the booster vaccination (Part B).
21. Has any psychiatric or cognitive disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2023
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital - Adelaide
Recruitment hospital [3] 0 0
Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bionet Co., Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Technovalia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Telethon Kids Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Institute for Clinical Pathology and Medical Research
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas WOOD, MB BS FRACP PhD.
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04742842