Coronavirus InfectionPhase 1COVAX19NCT04453852
Monovalent Recombinant COVID19 Vaccine
A Phase 1 study testing COVID19 vaccine and Saline in people with Coronavirus Infection and COVID, run by Vaxine Pty Ltd at 1 site in Australia.
Trial summary
This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, COVID
- What is being tested?
- COVID19 vaccine and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2020to 14 Apr 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects eligible to participate in this trial had to meet all of the following inclusion criteria:
- Provide written informed consent prior to initiation of any study procedures.
- Healthy males or non-pregnant females, aged 18 years to 65 years inclusive.
- Women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination.
- 2Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.
- 3Includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill").
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination
- Are able to understand and comply with planned study procedures and be available for all study visits.
Who cannot join
- • Have an acute illness, as determined by the site Principal Investigator (PI) or appropriate sub-investigator, within 72 hours prior to study vaccination.
- Have a history of documented COVID-19 infection or a known positive COVID-19 antibody test.
- Liver function tests (ALT, AST or GGT) > 2 times upper limit of normal
- eGFR <55 mL/min/1.73 m2
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
Show all 24Show fewer
- Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
- Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
- Have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines.
- Have a history of Guillain-Barré Syndrome.
- Have known hypersensitivity or allergy to insect stings or other components of the study vaccine.
- Have a history of epilepsy or febrile convulsions
- Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
- Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
- Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site PI or appropriate sub-investigator.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
- Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
- Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination.
- Female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
- Positive urine or serum pregnancy test within 24 hours prior to any study vaccination
- Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period.
- Have any medical disease or condition that, in the opinion of the Investigator, is a contraindication to study participation.
- Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation. *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- Any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects
This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.
Read the detailed description
Human infections with zoonotic coronaviruses including severe acute respiratory syndrome coronavirus (SARS CoV), Middle East respiratory syndrome-associated coronavirus (MERS CoV) and now 2019 SARS-CoV-2, all pose major human public health threats with high case fatality rates. The outbreak of SARS-CoV-2, which shares high similarity with SARS-CoV in its viral genome, has so far caused more than 4,736,000 cases worldwide (as of May 17, 2020) with 3131,545 deaths, resulting in an estimated overall mortality rate of 4-5%. It has a particularly high mortality rate in elderly people and those with chronic disease. To fight the current outbreak and prepare for future human outbreaks of similar coronaviruses, development of a safe and effective SARS-COV-2 vaccine remains a high priority. The fatality rate in the elderly is very high, being 8% for those over 70 and over 20% for those over 80. Notably, over 16% of the Australian population is aged 65 or older. Currently there is no way to control infection with SARS-COV-2 other than minimise exposure by social isolation.
Development of a vaccine against COVID-19 would deliver major public health and economic benefits for Australia, with potential to prevent numerous deaths, particularly among the Australian elderly, reducing the burden on hospital ICUs, helping to alleviate public concern, and ultimately allowing the Australian economy to return as fast as possible to normal.
SARS-CoV and SARS-CoV-2 are both closely related enveloped, single positive-stranded RNA viruses, with one genome encoding a non-structural replicase polyprotein and structural proteins, including spike (S), envelope (E), membrane (M) and nucleocapsid (N) proteins. SARS virus neutralizing antibodies were shown to be directed against the S protein. S protein can be cleaved into S1 and S2 subunits by proteases and within the S1 subunit there is a receptor-binding domain (RBD), which was shown to bind angiotensin-converting enzyme 2 (ACE2), which mediates SARS virus entry into cells. SARS-CoV-2 spike protein similarly binds ACE2 for cellular entry. Hence a recombinant SARS-CoV-2 spike protein vaccine that induces neutralising antibody against the virus should be effective against SARS-CoV-2 infection just as seen for SARS CoV.
SARS-COV-2 vaccine design is best informed by previous experience with closely related SARS CoV vaccines. Antibodies against the coronavirus spike protein blocks infection. When recombinant SARS spike protein vaccines produced in insect cells were formulated with Advax adjuvant, this enhances neutralizing antibody and T cell responses which translate into rapid lung viral clearance. Based on experience with developing successful and safe SARS and MERS vaccines, Covax-19 vaccine design is based on recombinant insect cell- expressed SARS-COV-2 spike protein formulated with Advax-SM adjuvant. The vaccine is based on recombinant expression of the ecto-domain of spike protein in insect cells. Insect cell expression of recombinant protein is a well characterised platform, allowing standardised procedures to be rapidly transferred to other facilities around the world. In response to the 2009 H1N1 influenza pandemic, roll-out of a pandemic vaccine based on hemagglutinin protein was extremely fast, with the first cGMP batches of vaccine produced within 6 weeks of virus discovery, and the first human trial subject dosed at Flinders just under 3 months after virus discovery . The use of Advax adjuvant doubled the seroconversion and seroprotection rates while maintaining vaccine tolerability and safety. Recombinant proteins manufactured using this method and formulated with Advax adjuvants have been found to be effective and safe in multiple human trials, including of H1N1/2009 and H5N1 (NCT02335164) and H7N9 (NCT03038776) influenza vaccines.
Covax-19 consists of highly purified recombinant SARS-COV-2 spike protein plus Advax-SM adjuvant in a sterile solution for intramuscular injection. COVAX-19™ vaccine is manufactured using a Sf9 platform. Advax-CpG adjuvant has previously been well tolerated and effective in trials of hepatitis B, H5N1 (NCT02335164) and H7N9 (NCT03038776) influenza vaccines and has recently been tested by the NIH in a US multicentre clinical trial with 2 quadrivalent seasonal influenza vaccines (NCT03945825).
COVAX-19™ vaccine is designed to elicit an immune response against SARS-CoV-2 with generation of neutralising antibodies against its spike protein that prevent the virus attaching to the human ACE2 receptor in the respiratory epithelium. It is also designed to induce T cells against the spike protein.
Study hypotheses
- COVAX-19 vaccine is safe and well tolerated in adult human subjects
- COVAX-19 vaccine will induce durable high titer neutralising antibodies and T cell responses against SARS-COV-2 virus.
- Conditions
- Coronavirus Infection, COVID
- Being tested
- COVID19 vaccine, Saline
- Keywords
- COVID19, coronavirus, vaccine, adjuvant
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID19 vaccineBiological
Also called COVAX-19 vaccine
COVID19 recombinant spike protein with Advax-SM adjuvant
SalineBiological
Also called Saline control
Saline control
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Spike antigen (25ug) + 15 mg Advax-2 adjuvant Receives: Biological: COVID19 vaccine |
| Group B | Placebo comparator | Saline Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Incidence of Adverse Events 1 week post immunisation
Measured: 1 week post immunisation
COVID19 antibody titers
COVID19 antibody titers post immunisation
Measured: 3 weeks post second immunisation
COVID19 T cell immunogenicity
Frequency of COVID19 spike specific T cells 1-3 weeks post second immunisation
Measured: 3 weeks post second immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start30 Jun 2020
- Primary completion1 Feb 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- Parallel groups
- Model description
- Randomised controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxine Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Central Adelaide Local Health Network Incorporated
- Responsible party
- Sponsor
- Investigators
- David Gordon, MBBS, Ph.D, Principal investigator, CALHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453852
- Sponsor's protocol ID
- 13110
- Acronym
- COVAX19
- Status last verified
- Feb 2022
- First submitted
- 3 Jun 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04453852
- Acronym / sponsor ID
- COVAX19 / 13110
- Conditions
- Coronavirus Infection, COVID
- Keywords
- COVID19, coronavirus, vaccine, adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vaxine Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Central Adelaide Local Health Network Incorporated
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 1 Jul 2020 (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.
This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.
Detailed description
Human infections with zoonotic coronaviruses including severe acute respiratory syndrome coronavirus (SARS CoV), Middle East respiratory syndrome-associated coronavirus (MERS CoV) and now 2019 SARS-CoV-2, all pose major human public health threats with high case fatality rates. The outbreak of SARS-CoV-2, which shares high similarity with SARS-CoV in its viral genome, has so far caused more than 4,736,000 cases worldwide (as of May 17, 2020) with 3131,545 deaths, resulting in an estimated overall mortality rate of 4-5%. It has a particularly high mortality rate in elderly people and those with chronic disease. To fight the current outbreak and prepare for future human outbreaks of similar coronaviruses, development of a safe and effective SARS-COV-2 vaccine remains a high priority. The fatality rate in the elderly is very high, being 8% for those over 70 and over 20% for those over 80. Notably, over 16% of the Australian population is aged 65 or older. Currently there is no way to control infection with SARS-COV-2 other than minimise exposure by social isolation.
Development of a vaccine against COVID-19 would deliver major public health and economic benefits for Australia, with potential to prevent numerous deaths, particularly among the Australian elderly, reducing the burden on hospital ICUs, helping to alleviate public concern, and ultimately allowing the Australian economy to return as fast as possible to normal.
SARS-CoV and SARS-CoV-2 are both closely related enveloped, single positive-stranded RNA viruses, with one genome encoding a non-structural replicase polyprotein and structural proteins, including spike (S), envelope (E), membrane (M) and nucleocapsid (N) proteins. SARS virus neutralizing antibodies were shown to be directed against the S protein. S protein can be cleaved into S1 and S2 subunits by proteases and within the S1 subunit there is a receptor-binding domain (RBD), which was shown to bind angiotensin-converting enzyme 2 (ACE2), which mediates SARS virus entry into cells. SARS-CoV-2 spike protein similarly binds ACE2 for cellular entry. Hence a recombinant SARS-CoV-2 spike protein vaccine that induces neutralising antibody against the virus should be effective against SARS-CoV-2 infection just as seen for SARS CoV.
SARS-COV-2 vaccine design is best informed by previous experience with closely related SARS CoV vaccines. Antibodies against the coronavirus spike protein blocks infection. When recombinant SARS spike protein vaccines produced in insect cells were formulated with Advax adjuvant, this enhances neutralizing antibody and T cell responses which translate into rapid lung viral clearance. Based on experience with developing successful and safe SARS and MERS vaccines, Covax-19 vaccine design is based on recombinant insect cell- expressed SARS-COV-2 spike protein formulated with Advax-SM adjuvant. The vaccine is based on recombinant expression of the ecto-domain of spike protein in insect cells. Insect cell expression of recombinant protein is a well characterised platform, allowing standardised procedures to be rapidly transferred to other facilities around the world. In response to the 2009 H1N1 influenza pandemic, roll-out of a pandemic vaccine based on hemagglutinin protein was extremely fast, with the first cGMP batches of vaccine produced within 6 weeks of virus discovery, and the first human trial subject dosed at Flinders just under 3 months after virus discovery . The use of Advax adjuvant doubled the seroconversion and seroprotection rates while maintaining vaccine tolerability and safety. Recombinant proteins manufactured using this method and formulated with Advax adjuvants have been found to be effective and safe in multiple human trials, including of H1N1/2009 and H5N1 (NCT02335164) and H7N9 (NCT03038776) influenza vaccines.
Covax-19 consists of highly purified recombinant SARS-COV-2 spike protein plus Advax-SM adjuvant in a sterile solution for intramuscular injection. COVAX-19™ vaccine is manufactured using a Sf9 platform. Advax-CpG adjuvant has previously been well tolerated and effective in trials of hepatitis B, H5N1 (NCT02335164) and H7N9 (NCT03038776) influenza vaccines and has recently been tested by the NIH in a US multicentre clinical trial with 2 quadrivalent seasonal influenza vaccines (NCT03945825).
COVAX-19™ vaccine is designed to elicit an immune response against SARS-CoV-2 with generation of neutralising antibodies against its spike protein that prevent the virus attaching to the human ACE2 receptor in the respiratory epithelium. It is also designed to induce T cells against the spike protein.
Study hypotheses
- COVAX-19 vaccine is safe and well tolerated in adult human subjects
- COVAX-19 vaccine will induce durable high titer neutralising antibodies and T cell responses against SARS-COV-2 virus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: COVID19 vaccineSpike antigen (25ug) + 15 mg Advax-2 adjuvant |
| Group B | Placebo comparator | Biological: SalineSaline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects eligible to participate in this trial had to meet all of the following inclusion criteria:
- Provide written informed consent prior to initiation of any study procedures.
- Healthy males or non-pregnant females, aged 18 years to 65 years inclusive.
- Women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination.
- 2Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.
Key exclusion criteria (24 listed)
- • Have an acute illness, as determined by the site Principal Investigator (PI) or appropriate sub-investigator, within 72 hours prior to study vaccination.
- Have a history of documented COVID-19 infection or a known positive COVID-19 antibody test.
- Liver function tests (ALT, AST or GGT) > 2 times upper limit of normal
- eGFR <55 mL/min/1.73 m2
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
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 |
|---|---|---|
| COVID19 vaccineAlso: COVAX-19 vaccineCOVID19 recombinant spike protein with Advax-SM adjuvant | Biological | Group A |
| SalineAlso: Saline controlSaline control | Biological | Group B |
Primary outcome
Incidence of Adverse Events
Time frame: 1 week post immunisation
Incidence of Adverse Events 1 week post immunisation
COVID19 antibody titers
Time frame: 3 weeks post second immunisation
COVID19 antibody titers post immunisation
COVID19 T cell immunogenicity
Time frame: 3 weeks post second immunisation
Frequency of COVID19 spike specific T cells 1-3 weeks post second immunisation
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 2 Mar 2022.
- Individual participant dataSharing planned: No
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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.
David Gordon, MBBS, Ph.D principal investigator
CALHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID19 vaccine and Saline in people with Coronavirus Infection and COVID, run by Vaxine Pty Ltd at 1 site 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 8 inclusion and 24 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Incidence of Adverse Events (time frame: 1 week post immunisation). The study lists 3 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 2 Mar 2022.