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 range

18 Years – 100 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of adverse events up to seven days after immunization

Timeframe: Seven days after each immunization

Frequency of adverse events up to 21 days after immunization

Timeframe: 21 days after each immunization

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-12-15

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