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A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial.
Chang-Monteagudo, Arturo; Ochoa-Azze, Rolando; Climent-Ruiz, Yanet; Macías-Abraham, Consuelo; Rodríguez-Noda, Laura; Valenzuela-Silva, Carmen; Sánchez-Ramírez, Belinda; Perez-Nicado, Rocmira; 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; Zúñiga-Rosales, Yaíma; Marcheco-Teruel, Beatriz; Rodríguez-Acosta, Mireida; Noa-Romero, Enrique; Enríquez-Puertas, Juliet; Porto-González, Delia; Fernández-Medina, Olivia; Valdés-Zayas, Anet; Chen, Guang-Wu; Herrera-Martínez, Luís; Valdés-Balbín, Yury; García-Rivera, Dagmar; Verez-Bencomo, Vicente.
  • Chang-Monteagudo A; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Ochoa-Azze R; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Climent-Ruiz Y; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Macías-Abraham C; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Rodríguez-Noda L; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Valenzuela-Silva C; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Sánchez-Ramírez B; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Perez-Nicado R; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Hernández-García T; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Orosa-Vázquez I; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Díaz-Hernández M; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • García-García MLÁ; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Jerez-Barceló Y; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Triana-Marrero Y; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Ruiz-Villegas L; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Rodríguez-Prieto LD; National Institute of Hematology and Immunology, 8th Ave. N° 460 between 17 and 19 Streets, Vedado, Havana, Cuba.
  • Puga-Gómez R; Cira Garcia Clinic, 20 Ave. N° 4101, Miramar, Playa, Havana, Cuba.
  • Guerra-Chaviano PP; National Coordinating Center of Clinical Trials, 5 Ave. between 60 and 62 Ave., Miramar, Playa, Havana, Cuba.
  • Zúñiga-Rosales Y; National Center of Medical Genetics, 31 Ave. N° 3102 and 146 Street, Cubanacán, Playa, Havana, Cuba.
  • Marcheco-Teruel B; National Center of Medical Genetics, 31 Ave. N° 3102 and 146 Street, Cubanacán, Playa, Havana, Cuba.
  • Rodríguez-Acosta M; Research Center of Civil Defense. San José de las Lajas, Mayabeque, Cuba.
  • Noa-Romero E; Research Center of Civil Defense. San José de las Lajas, Mayabeque, Cuba.
  • Enríquez-Puertas J; Research Center of Civil Defense. San José de las Lajas, Mayabeque, Cuba.
  • Porto-González D; National Blood Program, Ministry of Health, 23 Ave. and N Street, Havana, Cuba.
  • Fernández-Medina O; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Valdés-Zayas A; Center of Molecular Immunology, 15 Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Chen GW; Chengdu Olisynn Biotech. Co. Ltd., People's Republic of China.
  • Herrera-Martínez L; State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, People's Republic of China.
  • Valdés-Balbín Y; Biocubafarma. Independencia Ave. N° 8126 and 100 Ave., Boyeros, Havana, Cuba.
  • García-Rivera D; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Verez-Bencomo V; Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
Lancet Reg Health Am ; 4: 100079, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1428239
ABSTRACT

BACKGROUND:

As a first step towards a vaccine protecting COVID-19 convalescents from reinfection, we evaluated FINLAY-FR-1A vaccine in a clinical trial.

METHODS:

Thirty COVID-19 convalescents aged 22-57 years were studied convalescents of mild COVID-19, asymptomatic convalescents, both with PCR-positive at the moment of diagnosis; and individuals with subclinical infection detected by viral-specific IgG. They received a single intramuscular injection of the FINLAY-FR-1A vaccine (50 µg of the recombinant dimeric receptor binding domain). The primary outcomes were safety and reactogenicity, assessed over 28 days after vaccination. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following vaccination was evaluated by ELISA and live-virus neutralization test. The effector T cellular response was also assessed. Cuban Public Registry of Clinical Trials, WHO-ICTRP https//rpcec.sld.cu/en/trials/RPCEC00000349-En.

FINDINGS:

No serious adverse events were reported. Minor adverse events were found, the most common, local pain 3 (10%) and redness 2 (6·7%). The vaccine elicited a >21 fold increase in IgG anti-RBD antibodies 28 days after vaccination. The median of inhibitory antibody titres (94·0%) was three times greater than that of the COVID-19 convalescent panel. Virus neutralization titres higher than 1160 were found in 24 (80%) participants. There was also an increase in RBD-specific T cells producing IFN-γ and TNF-α.

INTERPRETATION:

A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 was an efficient booster of pre-existing natural immunity, with excellent safety profile.

FUNDING:

Partial funding for this study was received from the Project-2020-20, Fondo de Ciencia e Innovación (FONCI), Ministry of Science, Technology and the Environment, Cuba.   RESUMEN. ANTECEDENTES Como un primer paso hacia una vacuna que proteja a los convalecientes de COVID-19 de la reinfección, evaluamos la vacuna FINLAY-FR-1A en un ensayo clínico.

MÉTODOS:

Se estudiaron treinta convalecientes de COVID-19 de 22 a 57 años convalecientes de COVID-19 leve y convalecientes asintomáticos, ambos con prueba PCR positiva al momento del diagnóstico; e individuos con infección subclínica detectada por IgG específica viral. Los participantes recibieron una dosis única por vía intramuscular de la vacuna FINLAY-FR-1A (50 µg del dominio de unión al receptor recombinante dimérico del SARS CoV-2). Las variables de medida primarias fueron la seguridad y la reactogenicidad, evaluadas durante 28 días después de la vacunación. La variable secundaria, la inmunogenicidad. La respuesta humoral, al inicio del estudio y después de la vacunación, se evaluó por ELISA y mediante la prueba de neutralización del virus vivo. También se evaluó la respuesta de células T efectoras. Registro Público Cubano de Ensayos Clínicos, WHO-ICTRP https//rpcec.sld.cu/en/trials/RPCEC00000349-En.

RESULTADOS:

No se reportaron eventos adversos graves. Se encontraron eventos adversos leves, los más comunes, dolor local 3 (10%) y enrojecimiento 2 (6·7%). La vacuna estimuló un incremento >21 veces de los anticuerpos IgG anti-RBD 28 días después de la vacunación. La mediana de los títulos de anticuerpos inhibidores (94·0%) fue aproximadamente tres veces mayor que la del panel de convalecientes de COVID-19. Se encontraron títulos de neutralización viral superiores a 1160 en 24 (80%) de los participantes. También hubo un aumento en las células T específicas de RBD que producen IFN-γ y TNF-α. INTERPRETACIÓN Una sola dosis de la vacuna FINLAY-FR-1A contra el SARS-CoV-2 reforzó eficazmente la inmunidad natural preexistente, con un excelente perfil de seguridad. FINANCIAMIENTO Se recibió un financiamiento parcial del Proyecto-2020-20, Fondo de Ciencia e Innovación (FONCI), Ministerio de Ciencia, Tecnología y Medio Ambiente, Cuba.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Lancet Reg Health Am Year: 2021 Document Type: Article Affiliation country: J.lana.2021.100079

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Lancet Reg Health Am Year: 2021 Document Type: Article Affiliation country: J.lana.2021.100079