A Extension Study to Evaluate the Safety Tolerability and Immunogenicity of UB-612 COVID-19 Vaccine

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    60
  • sponsor
    United Biomedical Inc., Asia
Updated on 31 July 2021

Summary

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 g in V-122 study.

Description

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 g in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 g with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

Details
Condition COVID-19; SARS-CoV-2, COVID-19; SARS-CoV-2
Treatment UB-612
Clinical Study IdentifierNCT04967742
SponsorUnited Biomedical Inc., Asia
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study
Women of childbearing potential and men must agree to practice medically effective contraception during study period
Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF)
Able to understand and agrees to comply with all study procedures and be available for all study visits
Ear temperature 38.0C
At screening visit, at least 6 months after first vaccination in the V-122 study

Exclusion Criteria

Female who is pregnant or positive in pregnancy test at screening visit
Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination
Any acute illness, as determined by the study investigator 3 days before booster vaccination
Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination
Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination
Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study
Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612
Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent
Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination
Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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