Trial RPCEC00000346
Publication Hernandez-Bernal , EClinicalMedicine, 2022
Dates: 2020-12-07 to 2021-02-09
Funding: Public/non profit (Center for Genetic Engineering and Biotechnology (CIGB), Havana (products, reagents); the Ministry of Public Health of Cuba (hospital facilities and general medical care of the participants).)
Conflict of interest: Yes

Methods
RCT
Location : Single center / Cuba
Follow-up duration (months): 1.87
25 mcg CIGB-66 (RBD) Abdala (n = 242)
50 mcg CIGB-66 (RBD) Abdala (n = 242)
Placebo (adjuvant) (n = 242)
Inclusion criteria
  • Aged between 19 and 80 years
  • healthy or with comorbidities, compensated
  • written informed consent to participate
Exclusion criteria
  • Virological diagnosis by RT-PCR of infection to SARS-CoV-2
  • contact or suspect of COVID-19
  • subjects at high risk of exposure to SARS-CoV-2 infection (health workers in 1st line of medical care)
  • acute infection in the last 15 days
  • autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion
  • treated in the last three months or with any medical condition that requires an immunomodulator, steroid (except topical or inhaled) or cytostatic during the study
  • body mass index ≤18 or ≥35 Kg/m2
  • tattoos in both deltoid regions
  • administration of any research product in the last three months
  • allergy to thiomersal or any other component of the medicament
  • pregnancy or breastfeeding
  • mental disorders
Interventions
Intervention
3 IM doses 25 mcg CIGB, each 14 days apart
3 IM doses 50 mcg CIGB, each 14 days apart
Control
3 IM doses adjuvant placebo, each 14 days apart
Participants
Randomized
726 participants
Characteristics of participants
Type of participants: Adults including elderly
N=726
389 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 19-80
Description of participants
Adults 19 to 80 years old that were SARS-CoV-2 infection-free and with no recent contact or high-risk of exposure to COVID-19 at a single center in Cuba
Primary outcome
In the register
1) Adverse clinical events [at 24, 48 and 72 hours, and on the 7th day]; 2) Seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 [on days 28 and 42 (for the short scheme 0-14-28) and 28, 56 and 70 (for the long scheme 0-28-56)]
In the report
Seroconversion day 56, define as at least a four-fold increase of antibody titers over baseline.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes, When the trial is complete, upon requests directed to the corresponding author and after approval of a proposal
Data accessibility: hernandez.bernal@cigb.edu.cu data can be shared through a secure online platform after signing a data access agreement
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 and pre-print articles, the prospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size specified was achieved (n=726). There is no change from the trial registration in the intervention and control interventions. The primary outcomes reported in the article reflect those in the registry. Some reported outcomes were not planned in the registry (neutralizing antibody seroconversion and GMTs). Participants in the 3 short schedule arms (n=66) from phase 1 were combined with the participants enrolled in phase 2 (n=660).
This study has been updated on June 21st, 2022 after publication of the trial report.