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OpenTrials
Completed

NCT Number: NCT04783311

Safety, Tolerance and Immunogenicity of EuCorVac-19 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

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Catholic University of Eunpyeong St.Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EuCorVac-19

Biological

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

Normal Saline

Other

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

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

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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