Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults
NCT ID: NCT04783311
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
279 participants
INTERVENTIONAL
2021-02-23
2022-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Phase 1 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Phase 1 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Phase 2 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Phase 2 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Phase 2 - Placebo comparator group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Interventions
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EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Eligibility Criteria
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Inclusion Criteria
* 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
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
19 Years
75 Years
ALL
Yes
Sponsors
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EuBiologics Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
Other Identifiers
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EuSNAP_COV101
Identifier Type: -
Identifier Source: org_study_id
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