SARS-CoV2 COVID-19Phase 1COVALIANCT04742842
The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers
A Phase 1 study testing COVIGEN C20 1.0mg vaccine ID in people with SARS-CoV2 COVID-19, run by University of Sydney at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 COVID-19
- What is being tested?
- COVIGEN C20 1.0mg vaccine ID
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesAustralia
- Study dates
- 21 Jun 2021to 30 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential participants must fulfil all of the following inclusion criteria to be eligible to participate in the study:
- Willing and capable of providing written informed consent prior to the performance of any study-specific procedure.
- Male or female, ≥18.0 to ≤75. 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 40 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 (Part A) or the Booster (Part B).
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- 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 (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;
- 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)..
- Clinical safety laboratory evaluations at Screening must be toxicity Grade 0 or 1, or 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.
- 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.
Who cannot join
- If any of the following exclusion criteria apply, the potential participant will not be permitted to participate in the study:
- 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).
- 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.
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- 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 (Part A only).
- 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,.
- 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).
- 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 (Part A only) 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 SARS CoV-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 (Part A only).
- 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).
- 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 (Part A) or before the booster vaccination (Part B) 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 (Part A) or before the booster vaccination (Part B).
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital
Adelaide, South Australia
Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute
Perth, Western Australia
Scientia Clinical Research
Randwick, New South Wales, 2031
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- SARS-CoV2 COVID-19
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIGEN C19 0.8 mg ID or Placebo IDBiological
2 doses of COVIGEN C19 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.
COVIGEN C19 2.0 mg IM or Placebo IMBiological
2 doses of COVIGEN C19 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.
COVIGEN C19 4.0 mg IM or Placebo IMBiological
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 vaccine IDBiological
COVIGEN C20 1.0mg ID vaccine will be given at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Part A: Arm1 (COVIGEN (C19) 0.8 mg ID or Placebo ID) | Experimental | 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. Receives: Biological: COVIGEN C19 0.8 mg ID or Placebo ID |
| Part A: Arm2 (COVIGEN (C19) 2.0 mg IM or Placebo IM) | Experimental | 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. Receives: Biological: COVIGEN C19 2.0 mg IM or Placebo IM |
| Part A; Arm 3 (COVIGEN (C19) 4.0 mg IM or Placebo IM) | Experimental | 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 Receives: Biological: COVIGEN C19 4.0 mg IM or Placebo IM |
| Part B: Arm 1 (COVIGEN (C20) 1.0 mg ID) in BNT162b2 primed participants | Experimental | 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) Receives: Biological: COVIGEN C20 1.0mg vaccine ID |
| Part B: Arm 2 (COVIGEN (C20) 1.0 mg ID) in ChAdOx1-S primed participants | Experimental | 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) Receives: Biological: COVIGEN C20 1.0mg vaccine ID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited local reactogenicity AEs
Percentage of participants with any local reaction (pain, swelling/induration, erythema/redness) for 7 days following each vaccination
Measured: Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Frequency of solicited systemic reactogenicity AEs
Percentage of participants with any systemic reaction (fever, fatigue, chills, myalgia, arthralgia, headache, nausea/vomiting and diarrhea) for 7 days following each vaccination
Measured: Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Frequency of any unsolicited AEs
Percentage of participants with unsolicited AEs up to Day 57
Measured: Day 1 to Day 57 after the 1st vaccination (Part A) or from Day 1 to Day 29 after booster vaccination (Part B).
Frequency of any serious adverse events (SAEs)
Percentage of participants with SAEs from Day 1 to 12 months after 1st vaccination
Measured: Day 1 to 12 months after 1st vaccination
Frequency of any medically attended adverse events (MAAES)
Measured by MedDRA classification, severity score and relatedness.
Measured: From Day 1 to 12 months after the 1st vaccination
Change in safety laboratory values from baseline
Number of participants with abnormal laboratory values (haematology, chemistry and urinalysis) by FDA toxicity scoring.
Measured: From Day1 to Day 36 in Part A and from Day 1 to Day 8 in Part B
Secondary outcomes (9)
GMTs for serum neutralizing antibody response
Level of neutralizing antibodies as measured by SARS-CoV-2 Neutralization assay
Measured: At day1, day 29 and day 57 (Part A) and Day 1, Day 8, Day 29 (Part B only);
GMFR from baseline for serum neutralizing antibody response
Measured by SARS-CoV-2 Neutralization assay
Measured: At day 57 (Part A) or day 29 (Part B)
Seroconversion rate for serum neutralizing antibody response
Defined as proportion of participants with a with a ≥4-fold rise
Measured: At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
GMTs for serum S1- and RBD-specific IgG antibody responses
SARS-CoV-2 anti-S1 and anti-RBD IgG antibody ELISAs
Measured: At day 1, day 29 and day 57 (Part A) and at Day 1, Day 8, Day 29; (Part B only)
GMFR from baseline for serum S1- and RBD-specific IgG antibody responses
As measured by ELISA
Measured: At day 57 (Part A) and at day 29 (Part B)
Seroconversion rate serum S1- and RBD-specific IgG antibody responses
Defined as the proportion of participants with a ≥ 4-fold rise
Measured: At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
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
SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot)
Measured: At day 1, day 29, and day 57 (Part A) or at Day 1, Day 8, and Day 29 (Part B only)
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
SARS-CoV-2 Spike Protein dual IFN-γ and IL-2 T-cell ELISpot (FluoroSpot)
Measured: At day 57 compared to baseline for Part A and at day 29 compare to baseline for Part B
Proportion of participants with significant T-cell responses for S protein specific IFN-γ and IL-2 T-cell responses
IL-2 T-cell ELISpot (FluoroSpot)
Measured: At day 57 for Part A and at day 29 for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start21 Jun 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Bionet Co., Ltd, Technovalia, Telethon Kids Institute, Institute for Clinical Pathology and Medical Research
- Responsible party
- Sponsor
- Investigators
- Nicholas WOOD, MB BS FRACP PhD., Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742842
- Sponsor's protocol ID
- COV101
- Acronym
- COVALIA
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04742842
- Acronym / sponsor ID
- COVALIA / COV101
- Conditions
- SARS-CoV2 COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Bionet Co., Ltd, Technovalia, Telethon Kids Institute, Institute for Clinical Pathology and Medical Research
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Arm1 (COVIGEN (C19) 0.8 mg ID or Placebo ID) | Experimental | Biological: COVIGEN C19 0.8 mg ID or Placebo IDParticipants 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. |
| Part A: Arm2 (COVIGEN (C19) 2.0 mg IM or Placebo IM) | Experimental | Biological: COVIGEN C19 2.0 mg IM or Placebo IMParticipants 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. |
| Part A; Arm 3 (COVIGEN (C19) 4.0 mg IM or Placebo IM) | Experimental | Biological: COVIGEN C19 4.0 mg IM or Placebo IMParticipants 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 |
| Part B: Arm 1 (COVIGEN (C20) 1.0 mg ID) in BNT162b2 primed participants | Experimental | Biological: COVIGEN C20 1.0mg vaccine IDParticipants 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) |
| Part B: Arm 2 (COVIGEN (C20) 1.0 mg ID) in ChAdOx1-S primed participants | Experimental | Biological: COVIGEN C20 1.0mg vaccine IDParticipants 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Potential participants must fulfil all of the following inclusion criteria to be eligible to participate in the study:
- Willing and capable of providing written informed consent prior to the performance of any study-specific procedure.
- Male or female, ≥18.0 to ≤75. 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 40 kg/m2, inclusive, at Screening.
Key exclusion criteria (22 listed)
- If any of the following exclusion criteria apply, the potential participant will not be permitted to participate in the study:
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVIGEN C19 0.8 mg ID or Placebo ID2 doses of COVIGEN C19 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29. | Biological | Part A: Arm1 (COVIGEN (C19) 0.8 mg ID or Placebo ID) |
| COVIGEN C19 2.0 mg IM or Placebo IM2 doses of COVIGEN C19 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29. | Biological | Part A: Arm2 (COVIGEN (C19) 2.0 mg IM or Placebo IM) |
| COVIGEN C19 4.0 mg IM or Placebo IM2 doses of COVIGEN C19 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29. | Biological | Part A; Arm 3 (COVIGEN (C19) 4.0 mg IM or Placebo IM) |
| COVIGEN C20 1.0mg vaccine IDCOVIGEN C20 1.0mg ID vaccine will be given at Day 1 | Biological | Part B: Arm 1 (COVIGEN (C20) 1.0 mg ID) in BNT162b2 primed participants, Part B: Arm 2 (COVIGEN (C20) 1.0 mg ID) in ChAdOx1-S primed participants |
Primary outcome
Frequency of solicited local reactogenicity AEs
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
9 secondary outcomes
GMTs for serum neutralizing antibody response
Time frame: At day1, day 29 and day 57 (Part A) and Day 1, Day 8, Day 29 (Part B only);
GMFR from baseline for serum neutralizing antibody response
Time frame: At day 57 (Part A) or day 29 (Part B)
Seroconversion rate for serum neutralizing antibody response
Time frame: At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
GMTs for serum S1- and RBD-specific IgG antibody responses
Time frame: At day 1, day 29 and day 57 (Part A) and at Day 1, Day 8, Day 29; (Part B only)
GMFR from baseline for serum S1- and RBD-specific IgG antibody responses
Time frame: At day 57 (Part A) and at day 29 (Part B)
Seroconversion rate serum S1- and RBD-specific IgG antibody responses
Time frame: At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B
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 (Part A) or at Day 1, Day 8, and Day 29 (Part B only)
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 for Part A and at day 29 compare to baseline for Part B
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 for Part A and at day 29 for Part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Undecided
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas WOOD, MB BS FRACP PhD. principal investigator
University of Sydney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVIGEN C20 1.0mg vaccine ID in people with SARS-CoV2 COVID-19, run by University of Sydney at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of solicited local reactogenicity AEs (time frame: Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.