Patria (Recombinant NDV Vectored Vaccine for SARS-CoV-2) / National Autonomous University of Mexico, Avimex, Mexican Social Security Institute - LARVOL DELTA

Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine. (PubMed, Sci Adv) - "To address these issues, we developed and locally manufactured the AVX/COVID-12 vaccine using a cost-effective Newcastle disease virus LaSota platform to express a stabilized SARS-CoV-2 spike protein (HexaPro-S)...No vaccinated participants experienced severe disease, hospitalization, or death. These findings support the use of AVX/COVID-12 as a booster to help achieve and maintain population immunity while addressing global inequities in vaccine distribution, and it has been approved for adult booster use in Mexico."

Clinical • Head-to-Head • Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8 • IFNG

Addressing SARS-CoV-2 evolution: neutralization of emerging variants of concern by the AVX/COVID-12 'Patria' vaccine based on HexaPro-S ancestral Wuhan spike or its updated BA.2.75.2 version. (PubMed, Front Immunol) - "These findings underscore the adaptability of NDV-based platforms in addressing the evolving SARS-CoV-2 landscape and reaffirm the ongoing utility of the ancestral Patria vaccine. Together, they demonstrate the potential of these platforms to drive the development of next-generation vaccines tailored to emerging viral threats, contributing to global health equity."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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. (PubMed, Vaccine) - "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."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Newcastle disease virus vector-based SARS-CoV-2 vaccine candidate AVX/COVID-12 activates T cells and is recognized by antibodies from COVID-19 patients and vaccinated individuals. (PubMed, Front Immunol) - "The AVX/COVID-12 vectored vaccine candidate demonstrates the ability to stimulate robust cellular responses and is recognized by antibodies primed by the spike protein present in SARS-CoV-2 viruses that infected patients, as well as in the mRNA BNT162b2 and AZ/ChAdOx-1-S vaccines. These results support the inclusion of the AVX/COVID-12 vaccine as a booster in vaccination programs aimed at addressing COVID-19 caused by SARS-CoV-2 and its VOCs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG

Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster. (clinicaltrials.gov) - P2/3 | N=4065 | Completed | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence (clinicaltrials.gov) - P2 | N=158 | Completed | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster. (clinicaltrials.gov) - P2/3 | N=4065 | Active, not recruiting | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Recruiting ➔ Active, not recruiting | N=3000 ➔ 4065 | Trial primary completion date: Sep 2023 ➔ Dec 2022

Enrollment change • Enrollment closed • Head-to-Head • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence (clinicaltrials.gov) - P2 | N=158 | Active, not recruiting | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Trial completion date: Jan 2023 ➔ Jul 2023

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico. (PubMed, NPJ Vaccines) - P1 | "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)...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."

Journal • P1 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

"Is the Patria Vaccine mono or bi-alent?" (@ThePerceptor)

Clinical

Phase II/III Immunogenicity and Safety Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster. (clinicaltrials.gov) - P2/3 | N=3000 | Recruiting | Sponsor: Laboratorio Avi-Mex, S.A. de C.V.

Head-to-Head • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Study of a Live rNDV Based Vaccine Against COVID-19 (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Sep 2022 | Trial primary completion date: Aug 2021 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence (clinicaltrials.gov) - P2 | N=158 | Active, not recruiting | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Recruiting ➔ Active, not recruiting | N=396 ➔ 158 | Trial primary completion date: Apr 2022 ➔ Aug 2022

Enrollment change • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Study of a Live rNDV Based Vaccine Against COVID-19 (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Laboratorio Avi-Mex, S.A. de C.V. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase II Immunogenicity Study of AVX/COVID-12 (Patria) Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence (clinicaltrials.gov) - P2; N=396; Recruiting; Sponsor: Laboratorio Avi-Mex, S.A. de C.V.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs. (PubMed, mBio) - "Therefore, additional vaccines-especially ones that can be produced locally and at low cost-are urgently needed. This work describes preclinical testing of a SARS-CoV-2 vaccine candidate which meets these criteria."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of a Live rNDV Based Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Laboratorio Avi-Mex, S.A. de C.V.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Study of a Live rNDV Based Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=90; Not yet recruiting; Sponsor: Laboratorio Avi-Mex, S.A. de C.V.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA