RT Journal Article
T1 Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial
A1 Borobia, Alberto
A1 Carcas, Antonio J.
A1 Pérez-Olmeda, Mayte
A1 Castaño, Luis
A1 Bertran, María Jesús
A1 García-Pérez, Javier
A1 Campins, Magdalena
A1 Portolés Pérez, Antonio
A1 González-Pérez, María
A1 García Morales, Maria Teresa
A1 Arana-Arri, Eunate
A1 Aldea, Marta
A1 Díez-Fuertes, Francisco
A1 Fuentes, Inmaculada
A1 Ascaso del Río, Ana
A1 Lora Pablos, David
A1 Imaz-Ayo, Natale
A1 Barón-Mira, Lourdes E.
A1 Agustí, Antonia
A1 Pérez-Ingidua, Carla
A1 Gómez De La Cámara, Agustín Ramón
A1 Ramón Arribas, José
A1 Ochando, Jordi
A1 Alcamí. José, 
A1 Belda-Iniesta, Cristóbal
A1 Frías, Jesús
A1 Martínez de Soto, Lucía
A1 Rodríguez Mariblanca, Amelia
A1 Díaz García, Lucía
A1 Ramírez García, Elena
A1 Seco Meseguer, Enrique
A1 Stewart Balbás, Stefan Mark
A1 Marín Candón, Alicia
A1 García García, Irene
A1 Urroz Elizalde, Mikel
A1 Monserrat Villatoro, Jaime
A1 De la Rosa, Paula
A1 Sanz García, Marta
A1 López Crespo, Cristina
A1 Mauleón Martínez, Vega
A1 De Madariaga Castell, Raquel
A1 Vitón Vara, Laura
A1 García Rodríguez, Julio
A1 Buño, Antonio
A1 López Granados, Eduardo
A1 Cámara, Carmen
A1 Rey Cuevas, Esther
A1 Ayllon García, Pilar
A1 Jiménez González, María
A1 Hernández Rubio, Victoria
A1 Moraga Alapont, Paloma
A1 Sánchez, Amparo
A1 Prieto, Rocío
A1 Llorente Gómez, Silvia
A1 Miragall Roig, Cristina
A1 Aparicio Marlasca, Marina
A1 De la Calle, Fernando
A1 Arsuaga, Marta
A1 Duque, Blanca
A1 Meijide, Susana
A1 García de Vicuña, Aitor
A1 Santorcuato, Ana
A1 Expósito, Iraide
A1 De Benito, Sara
A1 Andia, Joseba
A1 Castillo, Cristina
A1 Irurzun, Esther
A1 Camino, Jesús
A1 Temprano, Mikel
A1 Goikoetxea, Josune
A1 Bustinza, Alazne
A1 Larrea, Maialen
A1 Gallego, Mikel
A1 García-Vázquez, Dolores
A1 De la Hoz, Ana Belén
A1 Pérez-Nanclares, Gustavo
A1 Pérez-Guzmán, Estíbaliz
A1 Idoyaga, Eneko
A1 Lamela, Adriana
A1 Oteo, Jesús
A1 Castillo de la Osa, María
A1 Hernández Gutiérrez, Lourdes
A1 Andrés Galván, María Elena
A1 Calonge, Esther
A1 Bermejo, Mercedes
A1 De la Torre-Tarazona, Erick Humberto
A1 Cascajero, Almudena
A1 Fedele, Giovanni
A1 Perea, Concepción
A1 Cervera, Isabel
A1 Bodega-Mayor, Irene
A1 Montes-Casado, María
A1 Portolés, Pilar
A1 Baranda, Jana
A1 Granés, Laura
A1 Lazaar, Sulayman
A1 Herranz, Sara
A1 Mellado, María Eugenia
A1 Tortajada, Marta
A1 Malet, Montserrat
A1 Quesada, Sebastiana
A1 Vilella, Anna
A1 Llupià, Anna
A1 Olivé, Victoria
A1 Trilla, Antoni
A1 Gómez, Begoña
A1 González, Elisenda
A1 Romero, Sheila
A1 Gámez, Francisco Javier
A1 Casals, Cristina
A1 Burunat, Laura
A1 Castelló, Juan José
A1 Fernández, Patricia
A1 Bedini, Josep Lluís
A1 Vila, Jordi
A1 Aguilar, Carla
A1 Altadill, Carmen
A1 Armadans, Lluis
A1 Borras-Bermejo, Blanca
A1 Calonge, Julia
A1 Camacho, Lina
A1 Feliu, Anna
A1 Gili, Gisela
A1 Llorente, Cesar
A1 Martínez-Gómez, Xavier
A1 Susana Otero-Romero, Susana
A1 Palacio, Esther
A1 Oleguer Parés, Oleguer
A1 Laia Pinós, Laia
A1 Aitana Plaza, Aitana
A1 Judit Riera-Arnau, Judit
A1 Rodrigo-Pendás, José Ángel
A1 Sans, Carla
A1 Santos, José
A1 Torres, Gloria
A1 Torrens, Margarita
A1 Uriona, Sonia
A1 Ballarin Alins, Elena
A1 Pérez Esquirol, Eulàlia
A1 Vendrell Bosch, Lourdes
A1 Laredo Velasco, Leonor
A1 Uribe López, Diana
A1 González Rojano, Esperanza
A1 Sánchez-Craviotto, Manuel
A1 Rivas Paterna, Ana Belén
A1 Iglesias Hernán-Gómez, Teresa
A1 Rodríguez Galán, Natalia
A1 Gil Marín. José Antonio, 
A1 Álvarez-Morales, Verónica
A1 Navalpotro, Ana Belén
A1 Jiménez-Santamaría, M Dolores
A1 Cardós, M Carmen
A1 Hermoso, Elena
A1 García-Arenillas, Mar
A1 Pérez Macías, Natalia
A1 Domingo Fernández, Alexandra
A1 López Picado, Amanda
A1 Mario Quiñones, Jorge
A1 Deidda, Nicoletta
A1 García-Franco, Ana
A1 Torvisco, José María
AB Background: To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of BNT162b2 (Comirnaty, BioNTech, Mainz, Germany) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria, AstraZeneca, Oxford, UK).Methods: We did a phase 2, open-label, randomised, controlled trial on adults aged 18-60 years, vaccinated with a single dose of ChAdOx1-S 8-12 weeks before screening, and no history of SARS-CoV-2 infection. Participants were randomly assigned (2:1) to receive either BNT162b2 (0·3 mL) via a single intramuscular injection (intervention group) or continue observation (control group). The primary outcome was 14-day immunogenicity, measured by immunoassays for SARS-CoV-2 trimeric spike protein and receptor binding domain (RBD). Antibody functionality was assessed using a pseudovirus neutralisation assay, and cellular immune response using an interferon-γ immunoassay. The safety outcome was 7-day reactogenicity, measured as solicited local and systemic adverse events. The primary analysis included all participants who received at least one dose of BNT162b2 and who had at least one efficacy evaluation after baseline. The safety analysis included all participants who received BNT162b2. This study is registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739), and is ongoing.Findings: Between April 24 and 30, 2021, 676 individuals were enrolled and randomly assigned to either the intervention group (n=450) or control group (n=226) at five university hospitals in Spain (mean age 44 years [SD 9]; 382 [57%] women and 294 [43%] men). 663 (98%) participants (n=441 intervention, n=222 control) completed the study up to day 14. In the intervention group, geometric mean titres of RBD antibodies increased from 71·46 BAU/mL (95% CI 59·84-85·33) at baseline to 7756·68 BAU/mL (7371·53-8161·96) at day 14 (p<0·0001). IgG against trimeric spike protein increased from 98·40 BAU/mL (95% CI 85·69-112·99) to 3684·87 BAU/mL (3429·87-3958·83). The interventional:control ratio was 77·69 (95% CI 59·57-101·32) for RBD protein and 36·41 (29·31-45·23) for trimeric spike protein IgG. Reactions were mild (n=1210 [68%]) or moderate (n=530 [30%]), with injection site pain (n=395 [88%]), induration (n=159 [35%]), headache (n=199 [44%]), and myalgia (n=194 [43%]) the most commonly reported adverse events. No serious adverse events were reported.Interpretation: BNT162b2 given as a second dose in individuals prime vaccinated with ChAdOx1-S induced a robust immune response, with an acceptable and manageable reactogenicity profile.
PB Elsevier
SN 0140-6736
YR 2021
FD 2021
LK https://hdl.handle.net/20.500.14352/115843
UL https://hdl.handle.net/20.500.14352/115843
LA eng
NO Borobia AM, Carcas AJ, Pérez-Olmeda M, Castaño L, Bertran MJ, García-Pérez J, Campins M, Portolés A, González-Pérez M, García Morales MT, Arana-Arri E, Aldea M, Díez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Barón-Mira LE, Agustí A, Pérez-Ingidua C, Gómez de la Cámara A, Arribas JR, Ochando J, Alcamí J, Belda-Iniesta C, Frías J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25. Erratum in: Lancet. 2021 Aug 14;398(10300):582. doi: 10.1016/S0140-6736(21)01805-5. PMID: 34181880; PMCID: PMC8233007.
NO Instituto de Salud Carlos III (ISCIII)
DS Docta Complutense
RD 6 abr 2025