tetano
Editor, Senior Moderator
Vaccine . 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
Vaccine
. 2024 Nov 10;43(Pt 2):126511.
doi: 10.1016/j.vaccine.2024.126511. Online ahead of print. 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
Constantino López-Macías[SUP] 1 [/SUP], Martha Torres[SUP] 2 [/SUP], Brenda Armenta-Copca[SUP] 3 [/SUP], Niels H Wacher[SUP] 4 [/SUP], Laura Castro-Castrezana[SUP] 5 [/SUP], Andrea Alicia Colli-Domínguez[SUP] 6 [/SUP], Tania Rivera-Hernández[SUP] 7 [/SUP], Alejandro Torres-Flores[SUP] 8 [/SUP], Matilde Damián-Hernández[SUP] 9 [/SUP], Luis Ramírez-Martínez[SUP] 10 [/SUP], Georgina Paz-De la Rosa[SUP] 10 [/SUP], Oscar Rojas-Martínez[SUP] 10 [/SUP], Alejandro Suárez-Martínez[SUP] 10 [/SUP], Gustavo Peralta-Sánchez[SUP] 10 [/SUP], Claudia Carranza[SUP] 2 [/SUP], Esmeralda Juárez[SUP] 11 [/SUP], Horacio Zamudio-Meza[SUP] 2 [/SUP], Laura E Carreto-Binaghi[SUP] 2 [/SUP], Mercedes Viettri[SUP] 2 [/SUP], Damaris Romero-Rodríguez[SUP] 12 [/SUP], Andrea Palencia[SUP] 2 [/SUP], Edgar Reyna-Rosas[SUP] 2 [/SUP], José E Márquez-García[SUP] 2 [/SUP], David Sarfati-Mizrahi[SUP] 9 [/SUP], Weina Sun[SUP] 13 [/SUP], Héctor Elías Chagoya-Cortés[SUP] 14 [/SUP], Felipa Castro-Peralta[SUP] 10 [/SUP], Peter Palese[SUP] 13 [/SUP], Florian Krammer[SUP] 15 [/SUP], Adolfo García-Sastre[SUP] 16 [/SUP], Bernardo Lozano-Dubernard[SUP] 17 [/SUP]
Affiliations
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.
Keywords: COVID-19 vaccine booster; Newcastle disease virus LaSota; Phase II clinical trial; SARS-CoV-2.
Vaccine
. 2024 Nov 10;43(Pt 2):126511.
doi: 10.1016/j.vaccine.2024.126511. Online ahead of print. 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
Constantino López-Macías[SUP] 1 [/SUP], Martha Torres[SUP] 2 [/SUP], Brenda Armenta-Copca[SUP] 3 [/SUP], Niels H Wacher[SUP] 4 [/SUP], Laura Castro-Castrezana[SUP] 5 [/SUP], Andrea Alicia Colli-Domínguez[SUP] 6 [/SUP], Tania Rivera-Hernández[SUP] 7 [/SUP], Alejandro Torres-Flores[SUP] 8 [/SUP], Matilde Damián-Hernández[SUP] 9 [/SUP], Luis Ramírez-Martínez[SUP] 10 [/SUP], Georgina Paz-De la Rosa[SUP] 10 [/SUP], Oscar Rojas-Martínez[SUP] 10 [/SUP], Alejandro Suárez-Martínez[SUP] 10 [/SUP], Gustavo Peralta-Sánchez[SUP] 10 [/SUP], Claudia Carranza[SUP] 2 [/SUP], Esmeralda Juárez[SUP] 11 [/SUP], Horacio Zamudio-Meza[SUP] 2 [/SUP], Laura E Carreto-Binaghi[SUP] 2 [/SUP], Mercedes Viettri[SUP] 2 [/SUP], Damaris Romero-Rodríguez[SUP] 12 [/SUP], Andrea Palencia[SUP] 2 [/SUP], Edgar Reyna-Rosas[SUP] 2 [/SUP], José E Márquez-García[SUP] 2 [/SUP], David Sarfati-Mizrahi[SUP] 9 [/SUP], Weina Sun[SUP] 13 [/SUP], Héctor Elías Chagoya-Cortés[SUP] 14 [/SUP], Felipa Castro-Peralta[SUP] 10 [/SUP], Peter Palese[SUP] 13 [/SUP], Florian Krammer[SUP] 15 [/SUP], Adolfo García-Sastre[SUP] 16 [/SUP], Bernardo Lozano-Dubernard[SUP] 17 [/SUP]
Affiliations
- PMID: 39527880
- DOI: 10.1016/j.vaccine.2024.126511
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.
Keywords: COVID-19 vaccine booster; Newcastle disease virus LaSota; Phase II clinical trial; SARS-CoV-2.