TY - JOUR
T1 - Phase II study on the safety and immunogenicity of single-dose intramuscular or intranasal administration of the AVX/COVID-12 “Patria” recombinant Newcastle disease virus vaccine as a heterologous booster against COVID-19 in Mexico
AU - López-Macías, Constantino
AU - Torres, Martha
AU - Armenta-Copca, Brenda
AU - Wacher, Niels H.
AU - Castro-Castrezana, Laura
AU - Colli-Domínguez, Andrea Alicia
AU - Rivera-Hernández, Tania
AU - Torres-Flores, Alejandro
AU - Damián-Hernández, Matilde
AU - Ramírez-Martínez, Luis
AU - la Rosa, Georgina Paz De
AU - Rojas-Martínez, Oscar
AU - Suárez-Martínez, Alejandro
AU - Peralta-Sánchez, Gustavo
AU - Carranza, Claudia
AU - Juárez, Esmeralda
AU - Zamudio-Meza, Horacio
AU - Carreto-Binaghi, Laura E.
AU - Viettri, Mercedes
AU - Romero-Rodríguez, Damaris
AU - Palencia, Andrea
AU - Reyna-Rosas, Edgar
AU - Márquez-García, José E.
AU - Sarfati-Mizrahi, David
AU - Sun, Weina
AU - Chagoya-Cortés, Héctor Elías
AU - Castro-Peralta, Felipa
AU - Palese, Peter
AU - Krammer, Florian
AU - García-Sastre, Adolfo
AU - Lozano-Dubernard, Bernardo
N1 - Publisher Copyright:
© 2024
PY - 2025/1/1
Y1 - 2025/1/1
N2 - Background: The global inequity in the distribution of COVID-19 vaccines underscores the urgent need for innovative and cost-effective vaccine technologies to address access disparities and implement local manufacturing capabilities. This is essential for achieving and sustaining widespread immunity, and for ensuring timely protection of vulnerable populations during future booster campaigns in lower- middle income countries (LMICs). Methods: To address this need, we conducted a phase II clinical trial to evaluate the safety and immunogenicity of the locally manufactured AVX/COVID-12 “Patria” (AVX) vaccine as a booster dose. The vaccine was administered either intramuscularly (IM) or intranasally (IN) to participants who had previously completed a vaccination regimen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using adenoviral vector, inactivated virus, or mRNA-based vaccines. Participants with initial anti-spike IgG titers below 1,200 U/mL were included, allowing us to observe the booster effect induced by vaccination. Results: Both IM and IN immunization with AVX were found to be safe and well-tolerated. The vaccine induced a significant (>2.5-fold) increase in neutralizing antibodies against the ancestral Wuhan strain and variants of concern (VOCs), including Alpha, Beta, Delta, and Omicron (BA.2 and BA.5). This immune response was further supported by increased cellular production of interferon-gamma (IFN-γ), demonstrating a robust and multifaceted immune reaction. Conclusions: The administration of AVX as a booster dose, whether through IM or IN routes, was safe and well-tolerated. The vaccine extended immune responses not only against the ancestral Wuhan-1 strain but also against various VOCs. Its ability to enhance preexisting immune responses suggests a potential contribution to expanding and sustaining herd immunity within the population.
AB - Background: The global inequity in the distribution of COVID-19 vaccines underscores the urgent need for innovative and cost-effective vaccine technologies to address access disparities and implement local manufacturing capabilities. This is essential for achieving and sustaining widespread immunity, and for ensuring timely protection of vulnerable populations during future booster campaigns in lower- middle income countries (LMICs). Methods: To address this need, we conducted a phase II clinical trial to evaluate the safety and immunogenicity of the locally manufactured AVX/COVID-12 “Patria” (AVX) vaccine as a booster dose. The vaccine was administered either intramuscularly (IM) or intranasally (IN) to participants who had previously completed a vaccination regimen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using adenoviral vector, inactivated virus, or mRNA-based vaccines. Participants with initial anti-spike IgG titers below 1,200 U/mL were included, allowing us to observe the booster effect induced by vaccination. Results: Both IM and IN immunization with AVX were found to be safe and well-tolerated. The vaccine induced a significant (>2.5-fold) increase in neutralizing antibodies against the ancestral Wuhan strain and variants of concern (VOCs), including Alpha, Beta, Delta, and Omicron (BA.2 and BA.5). This immune response was further supported by increased cellular production of interferon-gamma (IFN-γ), demonstrating a robust and multifaceted immune reaction. Conclusions: The administration of AVX as a booster dose, whether through IM or IN routes, was safe and well-tolerated. The vaccine extended immune responses not only against the ancestral Wuhan-1 strain but also against various VOCs. Its ability to enhance preexisting immune responses suggests a potential contribution to expanding and sustaining herd immunity within the population.
KW - COVID-19 vaccine booster
KW - Newcastle disease virus LaSota
KW - Phase II clinical trial
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85208309749&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2024.126511
DO - 10.1016/j.vaccine.2024.126511
M3 - Article
AN - SCOPUS:85208309749
SN - 0264-410X
VL - 43
JO - Vaccine
JF - Vaccine
M1 - 126511
ER -