ClinicalTrials.gg
CompletedNCT04783311Updated May 19, 2023

Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults

A Phase 1/2 interventional study of EuCorVac-19 and Normal Saline in COVID-19, sponsored by EuBiologics Co.,Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by EuBiologics Co.,Ltd · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
279
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 279 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals who voluntarily decide to participate in this study and provide written

    • 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)
  2. Individuals who are available for all visit procedures including telephone visits during the study period

Exclusion criteria

Exclusion Criteria:

  1. COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
  2. History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
  3. History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
  4. Immune system disorders including immunodeficiency disease
  5. abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
  6. Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
  7. Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
  8. History of severe allergic reactions or severe reactions to the IP or any of its components
  9. History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
  10. Women of who do not agree to use medically allowed methods of or to be heterosexually inactive until 60 days after the last dose of the IP
  11. Pregnant or breastfeeding woman
  12. Treatment with other IPs within 6 months prior to participation in this study
  13. Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
279 participants (actual)

Study arms

  • Experimental
    Phase 1 - EuCorVac-19 Low dose group

    Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

    Biological: EuCorVac-19 · Other: Normal Saline

  • Experimental
    Phase 1 - EuCorVac-19 High dose group

    Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

    Biological: EuCorVac-19 · Other: Normal Saline

  • Experimental
    Phase 2 - EuCorVac-19 Low dose group

    Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

    Biological: EuCorVac-19

  • Experimental
    Phase 2 - EuCorVac-19 High dose group

    Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

    Biological: EuCorVac-19

  • Active comparator
    Phase 2 - Placebo comparator group

    Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

    Other: Normal Saline

Interventions

  • BiologicalEuCorVac-19

    Two intramuscular doses (0.5mL per dose) at 3-week interval

  • OtherNormal Saline

    Two intramuscular doses (0.5mL per dose) at 3-week interval

06

What researchers measure

Primary outcomes

  1. Immediate AEs

    Time frame: within 30 minutes after each IP dosing

  2. Solicited local and systemic AEs

    Time frame: for 7 days after each IP dosing

  3. Unsolicited AEs

    Time frame: within 28 days after the last IP dosing

  4. SAEs

    Time frame: within 52 weeks after the last IP dosing

  5. AESIs

    Time frame: within 52 weeks after the last IP dosing

07

Study locations

1 site
  • The Catholic University of Eunpyeong St.Mary's Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Sia 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04783311
Lead sponsor
EuBiologics Co.,Ltd
Responsible party
Sponsor
First posted
Mar 5, 2021
Start date
Feb 23, 2021
Primary completion
Oct 15, 2021
Completion
Sep 27, 2022
Last update
May 19, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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