Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
No abstract available
Article activity feed
-
-
SciScore for 10.1101/2021.11.14.21266309: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Both trials are published in the Cuban Public Registry of Clinical Trials, included in WHO International Clinical Registry Trials Platform with codes RPCEC00000340 and RPCEC00000347. [21, 22] Ethical considerations: Phase I clinical trial was approved by the Ethical Committee at the Cuban National Centre for Toxicology; phase IIa was approved by a Research Ethic Committee from the Medical Sciences University, Faculty of Medicine “Manuel Fajardo”, Havana, designed by the Health Innovation Committee from the Cuban Ministry of Health (MINSAP).
Consent: Written informed consent was obtained from all participants.Sex as a biological variable Participants and study design: Eligible … SciScore for 10.1101/2021.11.14.21266309: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Both trials are published in the Cuban Public Registry of Clinical Trials, included in WHO International Clinical Registry Trials Platform with codes RPCEC00000340 and RPCEC00000347. [21, 22] Ethical considerations: Phase I clinical trial was approved by the Ethical Committee at the Cuban National Centre for Toxicology; phase IIa was approved by a Research Ethic Committee from the Medical Sciences University, Faculty of Medicine “Manuel Fajardo”, Havana, designed by the Health Innovation Committee from the Cuban Ministry of Health (MINSAP).
Consent: Written informed consent was obtained from all participants.Sex as a biological variable Participants and study design: Eligible participants were healthy persons according to clinical and laboratory criteria, aged 19–59 years (phase I) or 19–80 years (phase IIa) of both sexes, recruited through public advertisement at community or professional environment close to the clinical site (Clinic #1, La Lisa Municipality in Havana). Randomization Forty volunteers were enrolled, randomly and sequentially assigned to two groups of 20, for receiving 28 days apart two doses of 15 µg or 25 µg of SOBERANA 02. Blinding Phase IIb included 810 volunteers in a double blind, randomized, placebo controlled trial and will be published separately. Power Analysis Statistical analysis: Sample size calculation was done considering a serious AE rate < 5% (for phase I) and <1% (for phase IIa). Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Other secondary outcomes were vaccine immunogenicity, seroconversion (≥ 4-fold increase to pre-vaccination value), kinetics of anti-RBD IgG production (on days 0, 14, 28, 42, 56, 70 and 84), neutralizing antibody titres (on days 0, 56 and 84) and inhibition of RBD-ACE2 interaction (on days 0, 14, 28, 42, 56, 70 and 84). anti-RBD IgGsuggested: NoneSeroconversion rates for IgG antibodies anti-RBD (≥4-fold increase in antibody concentration over baseline) were calculated. IgGsuggested: Noneanti-RBDsuggested: NoneExperimental Models: Cell Lines Sentences Resources It is colorimetric assays based on the of the virus neutralization by antibodies, avoiding the cytopathic effect on VeroE6 cells. VeroE6suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)Software and Algorithms Sentences Resources Both trials were conducted according to Helsinki’s Declaration, Good Clinical Practice and the Cuban National Immunization Program. National Immunization Programsuggested: (Centers for Disease Control and Prevention, RRID:SCR_012976)Statistical analyses were done using SPSS version 25·0; R version 3·2·4; EPIDAT version 4·1 and Prism GraphPad version 6·0. SPSSsuggested: (SPSS, RRID:SCR_002865)Prismsuggested: (PRISM, RRID:SCR_005375)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)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:The main limitation of our study is its open label design; the lack of a control-placebo group precludes the comparison with unvaccinated subjects. In conclusion, SOBERANA 02 is safe, well tolerated and immunogenic in adult aged 19-80 years. Application of a heterologous scheme with SOBERANA Plus increased the immune response with excellent safety profile, reinforcing the induction of memory cells. These results pave the way for further evaluation of the heterologous scheme in phase IIb and phase III clinical trials.
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.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
-
