Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine (NCT04930003) | Clinical Trial Compass
CompletedPhase 1/2
Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine
Kazakhstan244 participantsStarted 2021-06-15
Plain-language summary
Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II Study of QazCoVac-P - COVID-19 Subunit Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Availability of signed and dated informed consent of the volunteer to
* participate in the study
* Healthy male and female volunteers aged 18-50 and 50 and above.
* Ability and voluntary desire to independently keep records in the SelfObservation Diary, as well as to carry out all the repeated visits provided for in the study for control medical observation.
* The voluntary desire of females to use methods of reliable contraception throughout the entire period of their participation in the study.
* Negative results for IgM and IgG antibodies to SARS-CoV-2.
* Absence of COVID-19 diagnosis in history.
* Absence in the last 14 days of close contact with persons suspected of being infected with SARS-CoV-2, or persons whose diagnosis of COVID-19 has been confirmed with laboratory.
* Negative test results for human immunodeficiency virus (HIV), hepatitis B and hepatitis C.
* Negative PCR results for coronavirus SARS-CoV-2
* According to the results of a chest x-ray, there is no pathological process in the lungs.
Exclusion Criteria:
* Aggravated allergic history, drug intolerance, including hypersensitivity to any of the components of the study drug, as well as a history of serious adverse events during vaccine administration (such as allergic reactions, respiratory failure, angioedema, abdominal pain).
* Acute illness with a fever (body temperature ≥37.1°C) at the time of screening/randomization.
* Chronic alcohol and/or drug use in history.
* Clinically si…
What they're measuring
1
Frequency of adverse events up to seven days after immunization
Timeframe: Seven days after each immunization
2
Frequency of adverse events up to 21 days after immunization
Timeframe: 21 days after each immunization
3
The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo
Timeframe: at days 0, 21, 27, 42, 90, 180
Trial details
NCT IDNCT04930003
SponsorResearch Institute for Biological Safety Problems