Trial RPCEC00000347
Publication Toledo-Romani ME, Med, 2022
Dates: 2021-01-15 to 2021-02-28
Funding: Public/non profit (Finlay Vaccine Institute; BioCubaFarma; the Fondo Nacional de Ciencia y Tecnica)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Cuba Follow-up duration (months): 8 | |
| SOBERANA 02/SOBERANA Plus (n = 708) Placebo (n = 102) |
|
| Inclusion criteria | Written informed consent to participate in the study; aged 19– 80 years; Women of childbearing potential, using safe contraceptive methods during the study; Physical examination: normal or without clinically significant alterations. |
| Exclusion criteria | Acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application; Antimicrobial treatment in the 7 days before the administration of the vaccine; Poor weight (BMI <18.5) and obesity (BMI ≥ 34.9); Non-transmissible chronic diseases not controlled according to clinical or laboratory criteria (eg., bronchial asthma, chronic obstructive pulmonary disease, diabetes mellitus, thyroid diseases, ischemic heart disease, arterial hypertension, psychiatric disease, hemolymphopoietic disease); Congenital or acquired immune system disease; History of unresolved neoplastic disease; History of liver or kidney failure; History of substance abuse during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics, and smoking; Diminished mental faculties for decision making; History of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria); History of hypersensitivity to thiomersal or to some of the components of the formulation; History of SARS-CoV-2 and COVID-19 who meet any of the following criteria: a) Previous or current history of SARS-CoV-2 infection. b) Be declared in the category of contact or suspect at the time of inclusion. c) Subject with positive test for anti-SARS-CoV-2 antibodies. d) Subject with positive PCR at the time of inclusion; Participation in another clinical trial in the last 3 months; Application of vaccines containing tetanus toxoid in the last 3 months; Application of other vaccines in the last 30 days; Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, biomodulina T, any gammaglobulin, Levamisole, Heberferon, thymosin) or other drugs with immunomodulatory action. Persons requiring immunomodulatory treatment during the study; Transfusion of blood or blood products in the last 3 months; Subjects with difficulties in attending the planned follow-up consultations; Splenectomy or splenic dysfunction; Pregnancy, puerperium or breastfeed; Tattoos in the deltoid region on both arms; positive pregnancy test. |
| Interventions | |
| Intervention
2 IM doses of SOBERANA 02 25 mcg and 1 IM dose of SOBERANA Plus 50 mcg, all 28 days apart |
|
| Control
2 IM doses of adjuvant, 28 days apart | |
| Participants | |
| Randomized 810 participants | |
| Characteristics of participants Type of participants: Adults N=810 401 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19-80 | |
| Description of participants Healthy adults with no known or suspected history of COVID-19 at 2 centers in Cuba. | |
| Primary outcome | |
| In the register Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 42, 56, 70, 84. | |
| In the report Percentage of subjects with seroconversion ≥4-fold the anti-RBD IgG pre-vaccination level. Serum samples were collected on days 0 (baseline) and 56 from all subjects; on days 14 and 70, blood samples were taken from 50% of the participants while samples from the other 50% were collected on days 42 and 84. | |
| Variants description | |
Variants
| |
| Description Variant name: initially D614G, then beta (March-June 2021) and finally delta (July-October 2021) Indirect evidence Method / missing outcome results: N/A for prevalence Other variant analyses: Neutralizing antibody titers against D614G variant and VOCs alpha, delta, beta and Omicron | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes, After publication in specialized journals |
| 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 and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved for phase IIb (100 were recruited into phase IIa). There were no important differences between registry and pre-print in population, procedures, interventions or outcomes. This trial was updated on October 24th 2022, after publication of the study report. |