A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial

Monteagudo, Arturo Chang; Ochoa-Azze, Rolando Felipe; Climent-Ruíz, Yanet; Abraham, Consuelo Milagros Macías; Rodríguez-Noda, Laura; Valenzuela-Silva, Carmen; Sánchez-Ramírez, Belinda; Pérez-Nicado, Rocmira; Gonzalez-Mugica, Raul; Hernández-García, Tays; Orosa-Vázquez, Ivette; Díaz-Hernández, Marianniz; García-García, María de los Ángeles; Jerez-Barceló, Yanet; Triana-Marrero, Yenisey; Ruiz-Villegas, Laura; Rodríguez-Prieto, Luis Dairon; Puga-Gómez, Rinaldo; Guerra-Chaviano, Pedro Pablo; Rosales, Yaíma Zúñiga; Marcheco-Teruel, Beatriz; Rodríguez-Acosta, Mireida; Noa-Romero, Enrique; Enríquez-Puertas, Juliet; Porto-Gonzalez, Delia; Leon-Monzon, Kalet; Chen, Guang-Wu; Martinez, Luis; Valdés-Balbín, Yury; García-Rivera, Dagmar; Vérez-Bencomo, Vicente

doi:10.1101/2021.02.22.21252091

Cited by 13 publications

(8 citation statements)

References 5 publications

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“…Secondary outcomes evaluated vaccine immunogenicity. One week after vaccination with a single dose, antibody response enhanced more than 20-fold compared to the Cuban convalescent serum panel's median [194].…”

Section: Viral Vector-based Vaccinementioning

confidence: 91%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

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COVID-19 vaccines are indispensable, with the number of cases and mortality still rising, and currently no medicines are routinely available for reducing morbidity and mortality, apart from dexamethasone, although others are being trialed and launched. To date, only a limited number of vaccines have been given emergency use authorization by the US Food and Drug Administration and the European Medicines Agency. There is a need to systematically review the existing vaccine candidates and investigate their safety, efficacy, immunogenicity, unwanted events, and limitations. The review was undertaken by searching online databases, i.e., Google Scholar, PubMed, and ScienceDirect, with finally 59 studies selected. Our findings showed several types of vaccine candidates with different strategies against SARS-CoV-2, including inactivated, mRNA-based, recombinant, and nanoparticle-based vaccines, are being developed and launched. We have compared these vaccines in terms of their efficacy, side effects, and seroconversion based on data reported in the literature. We found mRNA vaccines appeared to have better efficacy, and inactivated ones had fewer side effects and similar seroconversion in all types of vaccines. Overall, global variant surveillance and systematic tweaking of vaccines, coupled with the evaluation and administering vaccines with the same or different technology in successive doses along with homologous and heterologous prime-booster strategy, have become essential to impede the pandemic. Their effectiveness appreciably outweighs any concerns with any adverse events.

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Section: Viral Vector-based Vaccinementioning

confidence: 91%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

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show abstract

“…The humoral immune response was compared with that of a Cuban Convalescent Serum Panel (CCSP) made with serum from 68 COVID-19 convalescent patients and characterized with the same techniques used in clinical trials [6,8].…”

Section: Immune Response Assessmentmentioning

confidence: 99%

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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“…Briefly, a two-dose regimen (prime-boost), including the first-dose rAd5-S (L.dose; 5 × 10 7 VPs) and the second-dose rAd5 RBD-N (H.dose; 10 8 VPs), was administered in an interval of 21 days. Moreover, a two-dose regimen (heterologous prime-boost), with the first dose of rAd5-S (H.dose; 10 8 VPs) vaccine and the second dose of SOBERANA vaccine (recombinant dimeric RBD protein) [11] , was administered in an interval of 28 days. Besides, a single-dose regimen (prime only), including a combination of rAd5-S and rAd5 RBD-N (10 8 VPs per 50 µL), was administered ( Fig.…”

Section: Methodsmentioning

confidence: 99%

Potency, toxicity and protection evaluation of PastoCoAd candidate vaccines: Novel preclinical mix and match rAd5 S, rAd5 RBD-N and SOBERANA dimeric-RBD protein

Hassan

Ali

Esmaeili

et al. 2022

Vaccine

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A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial

Cited by 13 publications

References 5 publications

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

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

Potency, toxicity and protection evaluation of PastoCoAd candidate vaccines: Novel preclinical mix and match rAd5 S, rAd5 RBD-N and SOBERANA dimeric-RBD protein

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