Trial RPCEC00000359
Publication Hernandez-Bernal F, SSRN, 2022
Dates: 2021-03-22 to 2021-04-03
Funding: Public/non profit (Center for Genetic Engineering and Biotechnology (CIGB), in Havana.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Cuba Follow-up duration (months): 3.4 | |
| 50mcg Abdala vaccine (n = 24146) placebo (n = 24144) |
|
| Inclusion criteria | Aged between 19 and 80 years; healthy adults or with comorbidities, compensated; written, informed consent to participate. |
| Exclusion criteria | Subjects with previous infection to SARS-CoV-2 confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR); at the moment of inclusion, individuals suspicious to have the infection or in contact with a COVID-19 case, or previous any acute infections in the last 15 days; chronic diseases decompensated at the time of inclusion; subject who had received a vaccine candidate against COVID-19; any medical condition that requires an immunomodulator, systemic steroid or cytostatic during the study. |
| Interventions | |
| Intervention
3 IM doses of 50mcg Abdala vaccine, each 14 days apart |
|
| Control
3 IM doses of placebo, each 14 days apart | |
| Participants | |
| Randomized 48290 participants | |
| Characteristics of participants Type of participants: Adults N=48290 23004 males Children: 0 Pregnant women: 0 Mean age: Age range: NR | |
| Description of participants Adults, healthy or with controlled co-morbidities and no history of SARS-CoV-2 at 18 centers in Cuba | |
| Primary outcome | |
| In the register Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product. | |
| In the report The efficacy of Abdala vaccine in preventing a first occurrence of symptomatic COVID-19, in individuals without evidence of prior exposure to SAR-CoV-2 infection with onset 14 days after the third dose of the immunization schedule | |
| Variants description | |
Variants
| |
| Description Our phase 3 clinical trial was conducted from March to June 2021, corresponding exactly with the second period/second wave of the pandemic in the country (between March and June 2021). This period was characterized by a continued increase in the incidence of cases associated with the expansion of the circulation of the Beta variant, and a 11·89-fold increase compared to the total reported cases in 2020 and 3·41 times the total reported from December 2020 to February 2021. The distribution of the variants changed over time according to the emergence and expansion of those with the greatest evolutionary advantage. In March, B.1.1.519 variant was detected and at this time, Beta and D614G circulated with a similar frequency (30·81%). From April to May, an increase in Beta circulation was observed. Additionally, the variants Gamma/P1, B.1.1.523 and Delta (B.1.617.2) were detected for the first time in April. Delta rapidly increased from 1·44% in May to 27·14% in June. In parallel, the Beta variant diminished from 60·58% in May, to 51·26% in June, so, the efficacy of Abdala vaccine was measured in the context of highly circulation of mutant viruses. | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes, On trial completion |
| 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 trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article reflect those in the registry. The trial (n = 48290) achieved its target sample size (n = 48000). Supplementary appendices and figures 2,3 and 4 referred to in the article were not available via the pre-print website at time of extraction. |