Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme

Toledo-Romaní, María Eugenia; Sanchez, Leslihana Verdecia; Gonzalez, Meybis Rodriguez; Noda, Laura Rodríguez; Silva, Carmen Valenzuela; Moreno, Beatriz Paredes; Ramírez, Belinda Sánchez; Pérez-Nicado, Rocmira; Mugica, Raul Gonzalez; García, Tays Hernández; Báez, Gretchen Bergado; Estopinan, Franciscary Pi; Sui, Otto Cruz; Quintero, Anitza Fraga; Montero, Majela Garcia; Díaz, Ariel Palenzuela; Roman, Gerardo Baro; Hernandez, Ivis Mendoza; Castillo, Sonsire Fernández; Ruíz, Yanet Climent; Santana-Mederos, Darielys; Gonzalez, Ubel Ramírez; García-Vega, Yanelda; Masson, Beatriz Perez; Chen, Guang-Wu; Ayo, Tammy Boggiano; Magaz, Eduardo Ojito; Rivera, Daniel G.; Balbín, Yury Váldes; Rivera, Dagmar García; Bencomo, Vicente Vérez

doi:10.1101/2021.11.14.21266309

Cited by 8 publications

(24 citation statements)

References 37 publications

(23 reference statements)

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“…A significantly higher response, except for cVNT50, was observed in female subjects, age group 19-59 and without comorbidities of high risk. In phase IIb the immunological response in elders´ subgroup was lower than that in 19-59 years subgroup, while in phase IIa, there were no differences between both age subgroups, except for mVNT50 [6]. This may be related to the smaller number of elderly subjects included in phase IIa (24) compared to the 157 analyzed in phase IIb.…”

Section: Discussionmentioning

confidence: 77%

“…Anti-RBD IgG response and molecular-and conventional-virus neutralization titers were evaluated as described [6] (See Supplementary Materials Appendix C). 9 determined on days 0, 14, 42, 56, 70, 84.…”

Section: Immune Response Assessmentmentioning

confidence: 99%

“…Phase I study evaluated safety, reactogenicity and immunogenicity of SOBERANA 02 at two doses (15 and 25 µg) in adults 19-59 years-old and compared SOBERANA 02 in a three-dose (homologous) schedule vs. an heterologous schedule (two doses of SOBERANA 02 and a third dose of SOBERANA Plus, a vaccine candidate whose active pharmaceutical ingredient is the RBD dimer) [5]. After an interim analysis, the higher dose (SOBERANA 02, 25 µg) was selected for phase II study [6] designed in two stages (IIa and IIb); IIa was an open trial evaluating the homologous and heterologous schedules in adults 19-80 years-old [7]. A pooled analysis of both phases I and IIa concluded that the heterologous scheme was safe, well tolerated and elicited the highest immune response, reinforcing memory cells [6].…”

Section: Introductionmentioning

confidence: 99%

“…After an interim analysis, the higher dose (SOBERANA 02, 25 µg) was selected for phase II study [6] designed in two stages (IIa and IIb); IIa was an open trial evaluating the homologous and heterologous schedules in adults 19-80 years-old [7]. A pooled analysis of both phases I and IIa concluded that the heterologous scheme was safe, well tolerated and elicited the highest immune response, reinforcing memory cells [6].…”

Section: Introductionmentioning

confidence: 99%

“…SOBERANA Plus batches were EC-CVRBDd-2008 and EC-CVRBDd-2101; placebo batch was: E1001PS02. Vaccines composition has been described previously [6]; the placebo contained the excipients of SOBERANA 02. Vaccine and placebo formulations were visually undistinguishable.…”

mentioning

confidence: 99%

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Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

Toledo-Romaní

García-Carmenate²,

Verdecia-Sánchez³

et al. 2022

Preprint

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Background: We report results of immunogenicity, safety and reactogenicity of SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults in a phase IIb clinical trial. Method: This phase IIb trial was designed as parallel, multicentre, adaptive, double blind, randomized and placebo-controlled. Subjects (N=810) aged 19-80 years were randomized to receive two doses of the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredient of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD IgG concentration. Secondary outcomes were safety, reactogenicity and neutralizing antibodies. Results: Seroconversion rate in vaccinees was respectively 76.3 and 96.8% after two or three doses, compared with 7.3% in placebo group. Anti-RBD IgG increased significantly after first and second dose of SOBERANA 02 respect to placebo group; and the third dose with SOBERANA Plus boosts the response compared to the second dose. Neutralizing IgG antibodies were detected against D614G and VOCs α, β and δ. Specific and functional antibodies were detected until 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%); with only one serious AE consistent with vaccination. Local pain was the most frequent AE. Conclusions: Two doses of SOBERANA 02 were well tolerated, safe an immunogenic in adults aged 19-80 years old. The heterologous combination with a third dose of SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000347

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Section: Discussionmentioning

confidence: 77%

Section: Immune Response Assessmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

Toledo-Romaní

García-Carmenate²,

Verdecia-Sánchez³

et al. 2022

Preprint

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Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.

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Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine

et al. 2023

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ImportanceThe protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown.ObjectiveTo evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults.Design, Setting, and ParticipantsA multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021.InterventionsIn cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection.Main Outcomes and MeasuresThe primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed.ResultsIn cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths.Conclusions and RelevanceIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19–related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price.Trial Registrationisrctn.org Identifier: IRCT20210303050558N1

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Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme

Cited by 8 publications

References 37 publications

Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine

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