Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico

Samuel Ponce-de-León, Martha Torres, Luis Enrique Soto-Ramírez, Juan José Calva, Patricio Santillán-Doherty, Dora Eugenia Carranza-Salazar, Juan Manuel Carreño, Claudia Carranza, Esmeralda Juárez, Laura E. Carreto-Binaghi, Luis Ramírez-Martínez, Georgina Paz De la Rosa, Rosalía Vigueras-Moreno, Alejandro Ortiz-Stern, Yolanda López-Vidal, Alejandro E. Macías, Jesús Torres-Flores, Oscar Rojas-Martínez, Alejandro Suárez-Martínez, Gustavo Peralta-SánchezHisaaki Kawabata, Irene González-Domínguez, José Luis Martínez-Guevara, Weina Sun, David Sarfati-Mizrahi, Ernesto Soto-Priante, Héctor Elías Chagoya-Cortés, Constantino López-Macías, Felipa Castro-Peralta, Peter Palese, Adolfo García-Sastre, Florian Krammer, Bernardo Lozano-Dubernard

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

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.

Original languageEnglish
Article number67
Journalnpj Vaccines
Volume8
Issue number1
DOIs
StatePublished - Dec 2023

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