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A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity.
Pérez-Rodríguez, Sonia; de la Caridad Rodríguez-González, Meiby; Ochoa-Azze, Rolando; Climent-Ruiz, Yanet; Alberto González-Delgado, Carlos; Paredes-Moreno, Beatriz; Valenzuela-Silva, Carmen; Rodríguez-Noda, Laura; Perez-Nicado, Rocmira; González-Mugica, Raúl; Martínez-Pérez, Marisel; Sánchez-Ramírez, Belinda; Hernández-García, Tays; Díaz-Machado, Alina; Tamayo-Rodríguez, Maura; Martín-Trujillo, Alis; Rubino-Moreno, Jorman; Suárez-Batista, Anamary; Dubed-Echevarría, Marta; Teresa Pérez-Guevara, María; Amoroto-Roig, Mayté; Chappi-Estévez, Yanet; Bergado-Báez, Gretchen; Pi-Estopiñán, Franciscary; Chen, Guang-Wu; Valdés-Balbín, Yury; García-Rivera, Dagmar; Verez-Bencomo, Vicente.
  • Pérez-Rodríguez S; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • de la Caridad Rodríguez-González M; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Ochoa-Azze R; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba. Electronic address: ochoa@finlay.edu.cu.
  • Climent-Ruiz Y; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Alberto González-Delgado C; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • Paredes-Moreno B; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Valenzuela-Silva C; Institute of Cybernetics, Mathematics and Physics. 15 Street N° 551 between C and D Streets, Vedado, Havana, Cuba.
  • Rodríguez-Noda L; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Perez-Nicado R; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • González-Mugica R; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Martínez-Pérez M; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Sánchez-Ramírez B; Center of Molecular Immunology, 15(th) Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Hernández-García T; Center of Molecular Immunology, 15(th) Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Díaz-Machado A; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • Tamayo-Rodríguez M; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • Martín-Trujillo A; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • Rubino-Moreno J; National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba.
  • Suárez-Batista A; Research Centre of Civil Defense, San José de las Lajas, Mayabeque, Cuba.
  • Dubed-Echevarría M; Research Centre of Civil Defense, San José de las Lajas, Mayabeque, Cuba.
  • Teresa Pérez-Guevara M; Research Centre of Civil Defense, San José de las Lajas, Mayabeque, Cuba.
  • Amoroto-Roig M; National Coordinating Centre of Clinical Trials, 5(th) Ave. between 60 and 62 Ave., Miramar, Playa, Havana, Cuba.
  • Chappi-Estévez Y; National Coordinating Centre of Clinical Trials, 5(th) Ave. between 60 and 62 Ave., Miramar, Playa, Havana, Cuba.
  • Bergado-Báez G; Center of Molecular Immunology, 15(th) Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Pi-Estopiñán F; Center of Molecular Immunology, 15(th) Ave. and 216 Street, Siboney, Playa, Havana, Cuba.
  • Chen GW; Chengdu Olisynn Biotech. Co. Ltd., and State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, People's Republic of China.
  • Valdés-Balbín Y; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • García-Rivera D; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
  • Verez-Bencomo V; Finlay Vaccine Institute. 21(st) Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba.
Vaccine ; 40(13): 2068-2075, 2022 03 18.
Article in English | MEDLINE | ID: covidwho-1671287
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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ABSTRACT

BACKGROUND:

The Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein is the target for many COVID-19 vaccines. Here we report results for phase I clinical trial of two COVID-19 vaccine candidates based on recombinant dimeric RBD (d-RBD).

METHODS:

We performed a randomized, double-blind, phase I clinical trial in the National Centre of Toxicology in Havana. Sixty Cuban volunteers aged 19-59 years were randomized into three groups (20 subjects each) 1) FINLAY-FR-1 (50 µg d-RBD plus outer membrane vesicles from N. meningitidis); 2) FINLAY-FR-1A-50 (50 µg d-RBD, three doses); 3) FINLAY-FR-1A-25 (25 µg d-RDB, three doses). The FINLAY-FR-1 group was randomly divided to receive a third dose of the same vaccine candidate (homologous schedule) or FINLAY-FR-1A-50 (heterologous schedule). The primary outcomes were safety and reactogenicity. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following each vaccination was evaluated using live-virus neutralization test, anti-RBD IgG ELISA and in-vitro neutralization test of RBDhACE2 interaction.

RESULTS:

Most adverse events were of mild intensity (63.5%), solicited (58.8%), and local (61.8%); 69.4% with causal association with vaccination. Serious adverse events were not found. The FINLAY-FR-1 group reported more subjects with adverse events than the other two groups. After the third dose, anti-RBD seroconversion was 100%, 94.4% and 90% for the FINLAY-FR-1, FINLAY-FR-1A-50 and FINLAY-FR-1A-25 respectively. The in-vitro inhibition of RBDhACE2 interaction increased after the second dose in all formulations. The geometric mean neutralizing titres after the third dose rose significantly in the group vaccinated with FINLAY-FR-1 with respect to the other formulations and the COVID-19 Convalescent Serum Panel. No differences were found between FINLAY-FR-1 homologous or heterologous schedules.

CONCLUSIONS:

Vaccine candidates were safe and immunogenic, and induced live-virus neutralizing antibodies against SARS-CoV-2. The highest values were obtained when outer membrane vesicles were used as adjuvant. TRIAL REGISTRY https//rpcec.sld.cu/en/trials/RPCEC00000338-En.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans / Middle aged / Young adult Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.02.029

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans / Middle aged / Young adult Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.02.029