Trial NCT04530396
Publication Logunov D, Lancet, 2021
Dates: 07/09/2020 to 24/11/2020
Funding: Mixed (Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Russia Follow-up duration (months): 2.56 | |
| •Gam-COVID-Vac (n=16501)
•Placebo (n=5476) |
|
| Inclusion criteria | Age 18 years or older; negative HIV, hepatitis B and C, and syphilis test results; negative anti-SARS-CoV-2 IgM and IgG antibody and SARS-CoV-2 PCR tests; no history of COVID-19; no contact with anyone with COVID-19 in the preceding 14 days; consent to use effective contraceptive methods; negative urine pregnancy test (for women of child-bearing potential); negative drug and alcohol tests at screening visit; no history of vaccine-induced reactions; and no acute infectious or respiratory disease in the 14 days before enrolment. |
| Exclusion criteria | Any vaccination in the 30 days before enrolment; steroids or immunoglobulins in the 30 days before enrolment; immunosuppression in the 3 months before enrolment; pregnancy or breastfeeding; acute coronary syndrome or stroke in the year before enrolment; tuberculosis or chronic systemic infections; allergy or hypersensitivity to the drug or components; neoplasms; blood donation in the 2 months before enrolment; splenectomy; neutropenia, agranulocytosis, significant blood loss, severe anaemia, or immunodeficiency in the 6 months before enrolment; active form of a disease caused by HIV, syphilis, or hepatitis B or C; anorexia or protein deficiency; large tattoos at the injection site; history of alcohol or drug addiction; participation in any other clinical trial; study centre staff or other employees directly involved in the trial or their families; or any other condition deemed a problem by the study physician. |
| Interventions | |
| Intervention
1 IM dose of rAd26-S 10^11 vp at day 1 followed by 1 IM dose of rAd5-S 10^11 vp at day 21 |
|
| Control
2 IM doses of the vaccine buffer composition 21 days apart | |
| Participants | |
| Randomized 21977 participants | |
| Characteristics of participants Type of participants: Adults N=21977 12158 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: 45.3 Age range: NR | |
| Description of participants SARS-CoV-2- and HIV infection-free adult volunteers at 25 centers in Russia | |
| Primary outcome | |
| In the register Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose, confirmed with PCR | |
| In the report The primary outcome was the proportion of participants with COVID-19 confirmed by PCR from day 21 after receiving the first dose. | |
| Variants description | |
| Variants | |
| Description | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, Upon completion of clinical trials and publication of the results of the completed study |
| 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 paper, the online trial registry and supplementary matrials were used for data extraction and assessment of bias. Protocol and statistical analysis plan were not available at the time of data extraction. This was an interim analysis of a phase 3 trial, recruitment is completed with 21,977 included participants; planned sample size was 40,000. The study is still ongoing and long term follow-up and general adverse events data are forthcoming. Results of per-protocol analyses were reported (from 21,862 participants). Immunogenicity results were reported for smaller subsets (from 58 to 456 participants) for logistical reasons and in line with the prospective registration. There were no major differences in population, procedures or interventions between the article and registry. |