TY - JOUR
T1 - Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico
AU - Ponce-de-León, Samuel
AU - Torres, Martha
AU - Soto-Ramírez, Luis Enrique
AU - Calva, Juan José
AU - Santillán-Doherty, Patricio
AU - Carranza-Salazar, Dora Eugenia
AU - Carreño, Juan Manuel
AU - Carranza, Claudia
AU - Juárez, Esmeralda
AU - Carreto-Binaghi, Laura E.
AU - Ramírez-Martínez, Luis
AU - Paz De la Rosa, Georgina
AU - Vigueras-Moreno, Rosalía
AU - Ortiz-Stern, Alejandro
AU - López-Vidal, Yolanda
AU - Macías, Alejandro E.
AU - Torres-Flores, Jesús
AU - Rojas-Martínez, Oscar
AU - Suárez-Martínez, Alejandro
AU - Peralta-Sánchez, Gustavo
AU - Kawabata, Hisaaki
AU - González-Domínguez, Irene
AU - Martínez-Guevara, José Luis
AU - Sun, Weina
AU - Sarfati-Mizrahi, David
AU - Soto-Priante, Ernesto
AU - Chagoya-Cortés, Héctor Elías
AU - López-Macías, Constantino
AU - Castro-Peralta, Felipa
AU - Palese, Peter
AU - García-Sastre, Adolfo
AU - Krammer, Florian
AU - Lozano-Dubernard, Bernardo
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - There is still a need for safe, efficient, and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at a low cost, similar to influenza virus vaccines, and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open-label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety, and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe, and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737.
AB - There is still a need for safe, efficient, and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at a low cost, similar to influenza virus vaccines, and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open-label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety, and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe, and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737.
UR - http://www.scopus.com/inward/record.url?scp=85159040970&partnerID=8YFLogxK
U2 - 10.1038/s41541-023-00662-6
DO - 10.1038/s41541-023-00662-6
M3 - Artículo
C2 - 37164959
AN - SCOPUS:85159040970
SN - 2059-0105
VL - 8
JO - npj Vaccines
JF - npj Vaccines
IS - 1
M1 - 67
ER -