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The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers (COVALIA)

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ClinicalTrials.gov Identifier: NCT04742842
Recruitment Status : Not yet recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Collaborators:
Bionet Co., Ltd
Technovalia
Telethon Kids Institute
Institute for Clinical Pathology and Medical Research
Information provided by (Responsible Party):
University of Sydney

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.

Each participant will be given 2 vaccinations, either two active vaccines or two placebo vaccines on Day 1 and Day 29.

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.


Condition or disease Intervention/treatment Phase
SARS-CoV2 COVID-19 Biological: COVIGEN 0.8 mg ID or Placebo ID Biological: COVIGEN 2.0 mg IM or Placebo IM Biological: COVIGEN 4.0 mg IM or Placebo IM Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, 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.
Primary Purpose: Prevention
Official 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
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Arm1 (COVIGEN 0.8 mg ID or Placebo ID)
Participants will be randomized to receive either COVIGEN (0.8 mg) given by ID (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart.
Biological: COVIGEN 0.8 mg ID or Placebo ID
2 doses of COVIGEN 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.

Experimental: Arm2 (COVIGEN 2.0 mg IM or Placebo IM)
Participants will be randomized to receive either COVIGEN (2 mg) given by IM (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart.
Biological: COVIGEN 2.0 mg IM or Placebo IM
2 doses of COVIGEN 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.

Experimental: Arm3 (COVIGEN 4.0 mg IM or Placebo IM)
Participants will be randomized to receive either COVIGEN (4 mg) given by IM (n=40) or saline placebo (n=10), administered in a two dose regimen, 28 days apart
Biological: COVIGEN 4.0 mg IM or Placebo IM
2 doses of COVIGEN 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29.




Primary Outcome Measures :
  1. Frequency of solicited local reactogenicity AEs [ Time Frame: Through 7 days post-vaccination ]
    Percentage of participants with any local reaction (pain, swelling/induration, erythema/redness) for 7 days following each vaccination

  2. Frequency of solicited systemic reactogenicity AEs [ Time Frame: Through 7 days post-vaccination ]
    Percentage of participants with any systemic reaction (fever, fatigue, chills, myalgia, arthralgia, headache, nausea/vomiting and diarrhea) for 7 days following each vaccination

  3. Frequency of any unsolicited AEs [ Time Frame: Day 1 to Day 57 ]
    Percentage of participants with unsolicited AEs up to Day 57

  4. Frequency of any serious adverse events (SAEs) [ Time Frame: Day 1 to 12 months after 1st vaccination ]
    Percentage of participants with SAEs from Day 1 to 12 months after 1st vaccination

  5. Frequency of any medically attended adverse events (MAAES) [ Time Frame: From Day 1 to 12 months after the 1st vaccination ]
    Measured by MedDRA classification, severity score and relatedness.

  6. Change in safety laboratory values from baseline [ Time Frame: From Day1 to Day 36 ]
    Number of participants with abnormal laboratory values (haematology, chemistry and urinalysis) by FDA toxicity scoring.


Secondary Outcome Measures :
  1. GMTs for serum neutralizing antibody response [ Time Frame: At day1, day 29 and day 57 ]
    Level of neutralizing antibodies as measured by SARS-CoV-2 Neutralization assay

  2. GMFR from baseline for serum neutralizing antibody response [ Time Frame: At day 57 ]
    Measured by SARS-CoV-2 Neutralization assay

  3. Seroconversion rate for serum neutralizing antibody response [ Time Frame: At day 57 compare to baseline ]
    Defined as proportion of participants with a with a ≥4-fold rise

  4. GMTs for serum S1- and RBD-specific IgG antibody responses [ Time Frame: At day 1, day 29 and day 57 ]
    SARS-CoV-2 anti-S1 and anti-RBD IgG antibody ELISAs

  5. GMFR from baseline for serum S1- and RBD-specific IgG antibody responses [ Time Frame: At day 57 ]
    As measured by ELISA

  6. Seroconversion rate serum S1- and RBD-specific IgG antibody responses [ Time Frame: At day 57 compare to baseline ]
    Defined as the proportion of participants with a ≥ 4-fold rise

  7. 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 [ Time Frame: At day 1, day 29, and day 57 ]
    SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot)

  8. 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 [ Time Frame: At day 57 compared to baseline ]
    SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot)

  9. Proportion of participants with significant T-cell responses for S protein specific IFN-γ and IL-2 T-cell responses [ Time Frame: At day 57 ]
    IL-2 T-cell ELISpot (FluoroSpot)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and capable of providing written informed consent prior to the performance of any study-specific procedure.
  • Male or female, ≥18.0 to ≤75.0 years of age, at the time of consent.
  • The participant must be in good health, as established by pertinent medical history, physical examination and vital signs assessments performed at Screening.
  • Body mass index (BMI) of 18 to 35 kg/m2, inclusive, at screening.
  • 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.
  • 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.
  • 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, or have a same sex partner, or have a partner who is permanently sterile or unable to become pregnant.
  • 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.
  • Clinical safety laboratory evaluations at Screening must be toxicity Grade 0 or 1 and deemed not clinically significant by the Investigator.
  • The participant must agree to refrain from donating blood or plasma during the study for non-study purposes.
  • The participant must agree to have study samples retained for secondary research including exploratory analyses.
  • The participant must be able to attend all scheduled visits and to understand and comply with planned study procedures, in the Investigator's judgement.

Exclusion Criteria:

  • Female participant who is breastfeeding or intends to become pregnant from Screening until at least 90 days after the 2nd vaccination.
  • 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.
  • 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.
  • 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.
  • History of demyelinating disease or Guillain Barre syndrome.
  • Eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm).
  • History of blood dyscrasia or significant disorder of coagulation that, in the opinion of the Investigator, contraindicates IM injection.
  • History of known or suspected hypersensitivity to Kanamycin or any vaccine component, or any severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reaction.
  • Presence of active viral or bacterial infection, with or without fever (tympanic temperature ≥38.0 °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 [see Section 4.3.5.2] may be delayed for full recovery if acceptable to the Investigator).
  • Positive serological test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or HIV (Type 1 or 2) antibody at Screening.
  • 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 or RT-PCR, at Screening.
  • Suspected SARS-CoV-2 infection/COVID-19, including individuals who are required to self-isolate.
  • Individuals currently working in occupations with high risk of exposure to SARSCoV-2, e.g. healthcare workers in direct care of COVID-19 patients, emergency responders or front-line workers.
  • 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
  • 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
  • Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination.
  • Received or plans to receive an inactivated vaccine within 2 weeks before or after each study vaccination (including influenza vaccines).
  • Received immunoglobulins and/or any blood or blood products within 3 months before the 1st vaccination or plans to receive any blood or blood products at any time during the study.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742842


Contacts
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Contact: Nicholas WOOD, MB BS FRACP PhD. +61 2 98451429 nicholas.wood@health.nsw.gov.au
Contact: Julie Romanin +61 2 9011 6266 jromanin@southernstarresearch.com

Locations
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Australia, New South Wales
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Contact: Dr. Christopher Argent, MB BS       christopher.argent@scientiaclinicalresearch.com   
Principal Investigator: Dr. Christopher Argent         
Australia, South Australia
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital
Adelaide, South Australia, Australia
Contact: Professor Helen Marshall, MB BS    +61 8 8161 8115    helen.marshall@adelaide.edu.au   
Contact: Meredith Krieg    +61 8 8161 7349    meredith.krieg@adelaide.edu.au   
Principal Investigator: Professor Helen Marshall         
Australia, Western Australia
Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute
Perth, Western Australia, Australia
Contact: Professor Peter Richmond, MB BS    +61 8 6319 1850    peter.richmond@uwa.edu.au   
Contact: Jennifer Kent    +61 8 6319 1850    jennifer.kent@telethonkids.org.au   
Principal Investigator: Professor Peter Richmond         
Sponsors and Collaborators
University of Sydney
Bionet Co., Ltd
Technovalia
Telethon Kids Institute
Institute for Clinical Pathology and Medical Research
Investigators
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Principal Investigator: Nicholas WOOD, MB BS FRACP PhD. University of Sydney
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT04742842    
Other Study ID Numbers: COV101
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No