Trial NCT04922788
Publication Nguyen TP, medRxiv, 2022
Dates: 2021-06-11 to 2021-12-13
Funding: Mixed (Nanogen Pharmaceutical Biotechnology JSC and the Ministry of Science and Technology (MOST) of Vietnam)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Vietnam Follow-up duration (months): 6 | |
| 25 mcg Nanocovax (n=9025) Placebo (n=4223) |
|
| Inclusion criteria | Men and non-pregnant women; at least 18 years of age; body mass index (BMI) of 16 to 41 (kg/m2); written consent. |
| Exclusion criteria | History of Covid-19 or positive results for SARS-CoV-2 at screening period confirmed by real-time reverse transcriptase polymerase-chain-reaction (RT-PCR) |
| Interventions | |
| Intervention
2 IM doses of 25 mcg, 28 days apart |
|
| Control
2 IM doses of adjuvant, 28 days apart | |
| Participants | |
| Randomized 13007 participants | |
| Characteristics of participants Type of participants: Healthy adults N=13007 6933 males Children: 0 Pregnant women: 0 Mean age: Age range: 18-85 | |
| Description of participants Healthy adult without previous or current SARS-CoV-2 infection in four centres in Vietnam. | |
| Primary outcome | |
| In the register 1) Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ] Per 1000 person-years of follow-up; 2) Percentage of participants reporting Serious adverse events or medically attended adverse events [ Time Frame: From dose 1 through one year after the last dose ]; 3) Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants [ Time Frame: days 0, 42, 180, 365 after vaccination ]; 4) Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants [ Time Frame: days 0, 42 after vaccination ] | |
| In the report 1) number and percentage of participants with solicited local and systemic adverse events which occurred within 7 days of vaccination and laboratory results (serum biochemistry and hematology) at days 0, 7, 28 and 42 according to FDA toxicity scoring; 2) anti-S IgG responses to Nanocovax evaluated by a chemiluminescence immunoassay (CLIA); 3) vaccine efficacy (VE) against severe illness and death; VE against symptomatic Covid-19 cases with clinical symptoms with onset at least 14 days after the second dose. | |
| 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 |
Variant delta: Some concerns |
| General comment | “In addition to the pre-print article, the prospective study registry was used in data extraction and risk of bias assessment. Neither the protocol or statistical analysis plan were available. The study was terminated early due to the ethical concerns regarding safety, however the trial achieved its target sample size (n = 13000). There are inconsistencies in the article regarding the numbers randomized to each arm." |