A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVI… (NCT05167253) | Clinical Trial Compass
WithdrawnPhase 1
A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines.
Stopped: Regulatory issues raised by the regulatory authority in Taiwan.
0Started 2022-02-15
Plain-language summary
This is a study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
Who can participate
Age range20 Years – 55 Years
SexALL
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Inclusion Criteria:
* Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrolment.
* Fully vaccinated with two injections of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. The second dose of AstraZeneca COVID-19 vaccine (ChAdOx1-S) must have been administered more than six (6) months from study Day 1. The CDC COVID-19 Vaccination Record Card or appropriate documentation (e.g., medical records) will be required for documentation.
* Women of childbearing potential and men must agree to practice medically effective contraception from vaccination until 30 days after the vaccination.
* Participant or the participant's legal representative must understand the procedures of the study and is 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.
* Must be able to read, understand, and complete the protocol-required questionnaires and/or diary.
* Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody
* Negative results of SARS-CoV-2 N protein IgG ELISA
* Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
* Ear temperature ≤ 38.0°C.
* Indexes of hematology, biochemistry and immunology laboratory tests are within the normal ranges, or not clinically significant as judged by investigators
Exclusion Criteria:
* History of anaphylaxi…