A Phase II Study Integrating a Single-Blind Safety Phase with a Double-Blind, Placebo-Controlled Randomized Phase, Assessing Single-Dose Intramuscular or Intranasal Administration to Evaluate the Safety and Immunogenicity of the Recombinant Vaccine Against COVID-19 (AVX/COVID-12 “Patria”) Based on an Active Newcastle Disease Viral Vector as a Heterologous Booster in Subjects with Evidence of Previous Immunity to SARS-CoV-2

• DOI: 10.1101/2024.02.11.24302594
• Publication Date: 2024-02-13T21:25:11Z
• Authors: Constantino López...; Martha Torres; Brenda Armenta-Copca; Niels Wacher; Laura Castro-Cast...; Andrea Alicia Col...; Tania Rivera-Hern...; Alejandro Torres-...; Luis Ramírez-Mart...; Georgina Paz-De l...; Oscar Rojas-Martínez; Alejandro Suárez-...; Gustavo Peralta-S...; Claudia Carranza; Esmeralda Juárez; Horacio Zamudio-Meza; Laura E. Carreto-...; Mercedes Viettri; Damaris Romero-Ro...; Andrea Palencia; Edgar Reyna-Rosas; José E. Márquez-G...; David Sarfati-Miz...; Weina Sun; Héctor Elías Chag...; Felipa Castro-Per...; Peter Palese; Florian Krammer; Adolfo García-Sastre; Bernardo Lozano-D...
• Keywords: Booster dose; Booster (rocketry); Herd Immunity

Abstract Background The global inequity in coronavirus disease 2019 (COVID-19) vaccine distribution, primarily affecting low- and middle-income countries (LMICs), highlights the urgent need for innovative cost-effective technologies to address availability disparities. This is crucial achieving sustaining widespread immunity protecting vulnerable populations during future booster campaigns. Methods To this need, we conducted a phase II clinical trial evaluating safety immunogenicity of AVX/COVID-12 “Patria” as dose. was administered through both intramuscular (IM) intranasal (IN) routes participants who had previously received severe acute respiratory syndrome 2 (SARS-CoV-2) vaccines based on adenoviral technology, inactivated virus, or mRNA technology. inclusion criterion involved individuals with initial anti-spike IgG titers below 1,200 U/mL, allowing observation effect induced by vaccination. Results Immunization resulted significant (>2.5 times) increase neutralizing antibodies against original Wuhan strain variants concern (VOCs) such Alpha, Beta, Delta, Omicron (BA.2 BA.5). immune response accompanied cellular interferon-gamma (IFN-γ) production, indicating robust multifaceted reaction. Conclusions administration dose, whether IM IN routes, safe well-tolerated. extended responses not only Wuhan-1 but also various VOCs. Its ability enhance preexisting suggests potential contribution expanding herd within population.