COVID-19Phase 1/2NCT04783311
Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults
A Phase 1/2 study testing EuCorVac-19 and Normal Saline in people with COVID-19, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- EuCorVac-19 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2021to 27 Sep 2022
- Phase
- Phase 1/2
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who voluntarily decide to participate in this study and provide written informed consent
- Healthy male and female adult at the age of 19 to 50 years (Part A)
- Healthy male and female adult at the age of 19 to 75 years (Part B)
- Individuals who are available for all visit procedures including telephone visits during the study period
Who cannot join
- COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
- History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
- History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
- Immune system disorders including immunodeficiency disease
- Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
- Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
Show all 13Show fewer
- Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
- History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
- History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
- Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP
- Pregnant or breastfeeding woman
- Treatment with other IPs within 6 months prior to participation in this study
- Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul
About this study
Official title: A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults
Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults
- Conditions
- COVID-19
- Being tested
- EuCorVac-19, Normal Saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuCorVac-19Biological
Two intramuscular doses (0.5mL per dose) at 3-week interval
Normal SalineOther
Two intramuscular doses (0.5mL per dose) at 3-week interval
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - EuCorVac-19 Low dose group | Experimental | Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval Receives: Biological: EuCorVac-19; Other: Normal Saline |
| Phase 1 - EuCorVac-19 High dose group | Experimental | Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval Receives: Biological: EuCorVac-19; Other: Normal Saline |
| Phase 2 - EuCorVac-19 Low dose group | Experimental | Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval Receives: Biological: EuCorVac-19 |
| Phase 2 - EuCorVac-19 High dose group | Experimental | Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval Receives: Biological: EuCorVac-19 |
| Phase 2 - Placebo comparator group | Active comparator | Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate AEs
Measured: within 30 minutes after each IP dosing
Solicited local and systemic AEs
Measured: for 7 days after each IP dosing
Unsolicited AEs
Measured: within 28 days after the last IP dosing
SAEs
Measured: within 52 weeks after the last IP dosing
AESIs
Measured: within 52 weeks after the last IP dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start23 Feb 2021
- Primary completion15 Oct 2021
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783311
- Sponsor's protocol ID
- EuSNAP_COV101
- Status last verified
- Dec 2022
- First submitted
- 3 Mar 2021
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lovell JF, Baik YO, Choi SK, Lee C, Lee JY, Miura K, Huang WC, Park YS, Woo SJ, Seo SH, Kim JO, Song M, Kim CJ, Choi JK, Kim J, Choo EJ, Choi JH. Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine. BMC Med. 2022 Nov 30;20(1):462. doi: 10.1186/s12916-022-02661-1.
PubMed 36447243Sia ZR, He X, Zhang A, Ang JC, Shao S, Seffouh A, Huang WC, D'Agostino MR, Teimouri Dereshgi A, Suryaprakash S, Ortega J, Andersen H, Miller MS, Davidson BA, Lovell JF. A liposome-displayed hemagglutinin vaccine platform protects mice and ferrets from heterologous influenza virus challenge. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2025759118. doi: 10.1073/pnas.2025759118.
PubMed 34050027
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04783311
- Acronym / sponsor ID
- EuSNAP_COV101
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 5 Mar 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.
Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - EuCorVac-19 Low dose group | Experimental | Biological: EuCorVac-19, Other: Normal SalineHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval |
| Phase 1 - EuCorVac-19 High dose group | Experimental | Biological: EuCorVac-19, Other: Normal SalineHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval |
| Phase 2 - EuCorVac-19 Low dose group | Experimental | Biological: EuCorVac-19Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval |
| Phase 2 - EuCorVac-19 High dose group | Experimental | Biological: EuCorVac-19Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval |
| Phase 2 - Placebo comparator group | Active comparator | Other: Normal SalineHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who voluntarily decide to participate in this study and provide written informed consent
- Individuals who are available for all visit procedures including telephone visits during the study period
Key exclusion criteria (13 listed)
- COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
- History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
- History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
- Immune system disorders including immunodeficiency disease
- Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
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 |
|---|---|---|
| EuCorVac-19Two intramuscular doses (0.5mL per dose) at 3-week interval | Biological | Phase 1 - EuCorVac-19 High dose group, Phase 1 - EuCorVac-19 Low dose group, Phase 2 - EuCorVac-19 High dose group, Phase 2 - EuCorVac-19 Low dose group |
| Normal SalineTwo intramuscular doses (0.5mL per dose) at 3-week interval | Other | Phase 1 - EuCorVac-19 High dose group, Phase 1 - EuCorVac-19 Low dose group, Phase 2 - Placebo comparator group |
Primary outcome
Immediate AEs
Time frame: within 30 minutes after each IP dosing
Solicited local and systemic AEs
Time frame: for 7 days after each IP dosing
Unsolicited AEs
Time frame: within 28 days after the last IP dosing
SAEs
Time frame: within 52 weeks after the last IP dosing
AESIs
Time frame: within 52 weeks after the last IP dosing
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 19 May 2023.
- Derived from this study: PubMed 36447243Lovell JF, Baik YO, Choi SK, Lee C, Lee JY, Miura K, Huang WC, Park YS, Woo SJ, Seo SH, Kim JO, Song M, Kim CJ, Choi JK, Kim J, Choo EJ, Choi JH. Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine. BMC Med. 2022 Nov 30;20(1):462. doi: 10.1186/s12916-022-02661-1.
- Derived from this study: PubMed 34050027Sia ZR, He X, Zhang A, Ang JC, Shao S, Seffouh A, Huang WC, D'Agostino MR, Teimouri Dereshgi A, Suryaprakash S, Ortega J, Andersen H, Miller MS, Davidson BA, Lovell JF. A liposome-displayed hemagglutinin vaccine platform protects mice and ferrets from heterologous influenza virus challenge. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2025759118. doi: 10.1073/pnas.2025759118.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EuCorVac-19 and Normal Saline in people with COVID-19, run by EuBiologics Co.,Ltd at 1 site in South Korea.
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 4 inclusion and 13 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 19 May 2023. 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Immediate AEs (time frame: within 30 minutes after each IP dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783311, which also lists 2 linked publications.
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 19 May 2023.