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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04783311
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Covid19 Biological: EuCorVac-19 Other: Normal Saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Two intramuscular doses (0.5mL per dose) at 3-week interval

Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval

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

Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval

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

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

Active Comparator: Phase 2 - Placebo comparator group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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)
  2. Individuals who are available for all visit procedures including telephone visits during the study period

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. Clinically significant 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 hypersensitivity 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 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
  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

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): NCT04783311


Contacts
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Contact: YJ Lee +82-2-572-6675 yjlee@eubiologics.com

Locations
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Korea, Republic of
The Catholic University of Eunpyeong St.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: JH Choi         
Sponsors and Collaborators
EuBiologics Co.,Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT04783311    
Other Study ID Numbers: EuSNAP_COV101
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases