Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults
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
1 other identifier
interventional
279
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Feb 2021
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2021
CompletedFirst Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2022
CompletedMay 19, 2023
December 1, 2022
8 months
March 3, 2021
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Immediate AEs
within 30 minutes after each IP dosing
Solicited local and systemic AEs
for 7 days after each IP dosing
Unsolicited AEs
within 28 days after the last IP dosing
SAEs
within 52 weeks after the last IP dosing
AESIs
within 52 weeks after the last IP dosing
Study Arms (5)
Phase 1 - EuCorVac-19 Low dose group
EXPERIMENTALHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Phase 1 - EuCorVac-19 High dose group
EXPERIMENTALHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Phase 2 - EuCorVac-19 Low dose group
EXPERIMENTALHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Phase 2 - EuCorVac-19 High dose group
EXPERIMENTALHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Phase 2 - Placebo comparator group
ACTIVE COMPARATORHealthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Interventions
Two intramuscular doses (0.5mL per dose) at 3-week interval
Two intramuscular doses (0.5mL per dose) at 3-week interval
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, South Korea
Related Publications (2)
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.
PMID: 36447243DERIVEDSia 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.
PMID: 34050027DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 5, 2021
Study Start
February 23, 2021
Primary Completion
October 15, 2021
Study Completion
September 27, 2022
Last Updated
May 19, 2023
Record last verified: 2022-12