Trial NCT04540419
Publication Lioznov D, medRxiv, 2022
Dates: 2020-09-11 to 2020-11-11
Funding: Private (NPO Petrovax Pharm LLC (Moscow, Russian Federation))
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Russia Follow-up duration (months): 6 | |
| 0.5 mL Ad5-nCoV (n=374) Placebo (adjuvant)(n=126) | |
| Inclusion criteria |
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| Exclusion criteria |
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| Interventions | |
| Intervention
1 IM dose of 5 x 10^10 VP Ad5-nCoV |
|
| Control
1 IM dose of placebo (adjuvant) | |
| Participants | |
| Randomized 500 participants | |
| Characteristics of participants Type of participants: Healthy adults N=500 199 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Healthy adult volunteers without obesity with no current or previous SARS-CoV-2 infection in 6 centres in Russia. | |
| Primary outcome | |
| In the register Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion [ Time Frame: Day 28 after vaccination ] Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies [receptor-binding domain, RBD] of S-protein SARS-CoV-2). | |
| In the report Seroconversion rate, specifically the percentage of individuals with a 4-fold or higher increase in antibody titres to the RBD of the SARS-CoV-2 S protein, 28 days after vaccination. | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, 3 years following publication |
| 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 pre-print article, the prospective study registry, protocol, supplementary material and statistical analysis plan were used in data extraction and risk of bias assessment. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The target sample size (n=500) specified in the registry was achieved (n=500). ******PERSONAL COMMENTS _ DO NOT PUBLISH ***** 1) Disease: Number with confirmed COVID reported to day 14 after vaccination. Protocol defines a confirmed case as: “A confirmed COVID-19 case means the presence of clinical manifestations and a positive laboratory test result for SARS-CoV-2 RNA.” Therefore extracted as disease rather than infection. Also, this was only for a single dose, not complete vaccination. Only single dose was planned. 2) N analyzed for immunogenicity: Not clearly reported. Flow chart says PPS for immunogenicity is 324/95 (this has been extracted) and the FAS for efficacy is 363/120, but the text reports “In the primary analysis on Day 28, 285 (78.5%, 95% CI: 73.9; 82.6) of 363 participants in the Ad5-nCoV group showed seroconversion of RBD-specific antibodies compared with 7 (5.9%; 95% CI: 2.4, 11.7) of 119 participants in the Placebo group.” 3) Local/systemic AE FU: Table 2 not labeled as Day 7, but the text reports “During the first 7 days after vaccination, a total of six serious AEs (SAEs) were reported (Table 2)”. Also, the events are described as “reactions” and the outcome is described as “The safety endpoints were reactogenicity (Day 0 to day 7)”. 4) All cause mortality denominator: I think mortality is a safety outcome, reported with the AEs etc., so I used the safety set (table 2) 372/124 |