Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike RBD protein vaccine: A randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study)
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
No abstract available
Article activity feed
-
-
-
SciScore for 10.1101/2021.11.30.21267047: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Subjects aged between 19 and 54 years (for phase I) and between 19 and 80 years (for phase II), who gave their written, informed consent to participate, were eligible.
IRB: The protocol followed the Declaration of Helsinki guidelines and was evaluated by the Ethics and Review Committee of the Provincial Hospital “Saturnino Lora” in Santiago de Cuba (clinical site participating in the trial), who granted ethical approval of the study.Sex as a biological variable not detected. Randomization A randomised, adaptive, double blind, placebo-controlled, phase 1-2 clinical trial was carried out in “Saturnino Lora” Hospital, Santiago de Cuba. Blinding A randomised, adaptive, double blind, … SciScore for 10.1101/2021.11.30.21267047: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Subjects aged between 19 and 54 years (for phase I) and between 19 and 80 years (for phase II), who gave their written, informed consent to participate, were eligible.
IRB: The protocol followed the Declaration of Helsinki guidelines and was evaluated by the Ethics and Review Committee of the Provincial Hospital “Saturnino Lora” in Santiago de Cuba (clinical site participating in the trial), who granted ethical approval of the study.Sex as a biological variable not detected. Randomization A randomised, adaptive, double blind, placebo-controlled, phase 1-2 clinical trial was carried out in “Saturnino Lora” Hospital, Santiago de Cuba. Blinding A randomised, adaptive, double blind, placebo-controlled, phase 1-2 clinical trial was carried out in “Saturnino Lora” Hospital, Santiago de Cuba. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources The main endpoints were: safety and proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2. SARS-CoV-2suggested: NoneIn phase 1 trial, blood samples were collected in all groups at day 0, before the application of the first dose (baseline), and at several points according to the corresponding vaccination schedule (at days 42 and 56 for the schedule 0-14-28 days and at days 56 and 70 for the schedule 0-28-56 days) to determine the level of RBD-specific IgG antibodies, in terms of seroconversion rates and geometric mean of the titers (GMT), the percentage of inhibition of RBD-ACE-2 binding in terms of proportions and media (95 % CI) and levels of neutralizing antibodies to live SARS-CoV-2 in terms of proportions an GMT. RBD-specific IgGsuggested: NoneIgG antibodies were quantified by UMELISA SARS-CoV-2 anti-RBD (Immunoassay Centre, Havana). anti-RBDsuggested: NoneIn phase 1 of the trial, it was expected to identify the two best experimental groups which would continue to the second phase considering: a) the percentage of seroconversion of anti-RBD IgG antibodies to SARS-CoV-2; b) the non-occurrence of serious adverse events with a causal relationship attributable to the research product in no more than 5% of the subjects. anti-RBD IgGsuggested: NoneSoftware and Algorithms Sentences Resources Assuming type I and II errors of 0.05 and 0.20, respectively, a sample size of 20 subjects was estimated using the PASS software (www.ncss.com). PASSsuggested: (PASS, RRID:SCR_005490)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:[33] This study has several limitations. First, immunogenicity was tested at day 14 and 30 after complete vaccination schedule, so the duration of the immune response cannot be assessed. Follow-up visits to evaluate long-term safety as well as the duration of the immune response at least 6 months after vaccination are underway. Second, we did not assess the T cell responses in the phase 2 trial. Third, the relevance of antibody response elicited by this vaccine to protection against COVID-19 disease has to be evaluated in phase 3 efficacy trials. Four, data of neutralizing antibody titers against emerging variants of SARS-CoV-2 require further studies currently ongoing. The ethnic diversity of the Cuban population, the wide age range studied and its comorbidities, contributes to the generalisability (external validity, applicability) of the trial findings, although they are still limited the sample size. In conclusion, the results of the phase 1-2 trial indicated that Abdala vaccine against SARS-CoV-2 was safe, well tolerated and induced humoral immune responses against SARS-CoV-2 among adults from 19 to 80 years of age. Our findings indicate that the a SARS-CoV-2 recombinant spike protein vaccine studied (Abdala) is a promising candidate that warrants testing in phase 3 studies, in a larger number of individuals older than 19 years of age and a three-dose schedule of 50 μg on days 0-14-28, evaluating vaccine efficacy in the prevention of symptomatic COVID-19 and progression ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
-