Trial NCT04530357
Publication Zakarya K, EClinicalMedicine, 2021
Dates: 2020-09-19 to 2020-09-23
Funding: Public/non profit (Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / Kazakhstan Follow-up duration (months): 6 | |
| QazCovid-in (n=22) Placebo (n=22) | |
| Inclusion criteria | Signed and dated informed consent form; healthy males and females aged 18-50 and over; able to keep records in the Self-Observation Diary independently and to undergo the medical monitoring during the follow-ups stipulated in the study and does this on their own volition; females voluntarily use the methods of reliable contraception throughout the entire period of their participation in the study; tests for IgM and IgG antibodies to SARS-CoV-2 are negative; no history of COVID-19 coronavirus infection; over the past 14 days, there was no close contact with individuals suspected of being infected with SARS-CoV-2, or individuals with a laboratory-confirmed diagnosis of coronavirus infection COVID-19; tests for human immunodeficiency virus (HIV), hepatitis B and hepatitis C are negative |
| Exclusion criteria | Known allergic reactions in history, intolerance to medication, including hypersensitivity to any of the components of the investigational product, beta-lactam antibiotics and aminoglycosides, as well as a history of serious adverse events after vaccination (such as allergic reactions, respiratory failure, angioedema, abdominal pain); acute condition with fever (body temperature ≥37.1 °C) is found at the screening/randomization stage; a history of chronic alcohol and/or drug abuse; laboratory and/or instrumental examination at the screening stage shows clinically significant deviations from normal values; women have a positive urine pregnancy test; received concurrent treatment with immunosuppressive agents, including corticosteroids (2 weeks), 4 weeks prior to the investigational product administration; medical history, physical examination, or clinical laboratory tests reveal conditions that may affect the study result, according to the investigator, including acute or chronic clinically significant disorders of the lungs, cardiovascular system, gastrointestinal tract, liver, or blood system, as well as skin, endocrine, neurological and psychiatric disorders or impaired renal function (asthma, diabetes, thyroid disease, arrhythmia, myocardial infarction, severe hypertension not controlled by medication, etc.); platelet disorders or other blood-clotting disorders, which may cause contraindications to intramuscular administration; a history of leukemia or neoplasm; autoimmune disease; has received antiviral medication, immunoglobulins, or blood transfusions or any other investigational product within 4 weeks before the studied investigational product administration; has received anti-inflammatory medicines 2 days before the investigational product administration; has participated in any other clinical trial within the last 3 months; suspected not to comply with the study requirements or has an evident physical or mental disability that may affect the completion of the study; refuses to participate in the study voluntarily; the subject is vulnerable |
| Interventions | |
| Intervention
2 IM doses of 5 mcg, 21 days apart |
|
| Control
2 IM doses of placebo, 21 days apart | |
| Participants | |
| Randomized 44 participants | |
| Characteristics of participants Type of participants: Heathy adults N=44 29 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18-50 | |
| Description of participants Healthy adults with no history of COVID-19 that tested negative for SARS-CoV-2 and HIV virus at a single centre in Kazakhstan. | |
| Primary outcome | |
| In the register 1) Frequency of adverse events up to seven days after immunization [ Time Frame: Seven days after each immunization ]; 2) Frequency of adverse events up to 21 days after immunization [ Time Frame: 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 [ Time Frame: at days 0, 21, 27, 42 ]; 4) Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples [ Time Frame: at days 0, 21, 27, 42 ] | |
| In the report 1) solicited adverse reactions within 7 days after each dose; 2) unsolicited adverse events (AEs) for 21 days after each vaccination; 3) geometric mean titres (GMTs) of S-specific antibodies measured on days 21 and 42 after vaccination; 4) GMTs of virus neutralizing antibodies measured on days 21 and 42 after vaccination | |
| Variants description | |
| Variants | |
| Description * | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the prospective trial registry and supplementary materials were used in data extraction and risk of bias assessment. Neither protocol or statistical analysis plan was available. The fourth primary outcome (Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples) was added to the registry near the end of the phase 1 and phase 2 studies. There were no other differences between trial registry and the published report in population, procedures, interventions or outcomes. The trial achieved its pre-specified sample size. |