PATH congratulates Thailand on granting conditional approval for emergency use to first locally produced COVID-19 vaccine
CastleVax Inc. Receives BARDA Project NextGen Award Valued at up to $338 Million to Advance Intranasal NDV-based COVID-19 Booster Vaccine into Phase 2b Clinical Efficacy Testing
CastleVax Inc. Receives BARDA Project NextGen Award Valued at up to $338 Million to Advance Intranasal NDV-based COVID-19 Booster Vaccine into Phase 2b Clinical Efficacy Testing
Promising Results of Next-Generation Intranasal COVID-19 Booster Vaccine: Implications for Infection Prevention and Transmission
Interim results show that intranasal delivery resulted in a robust S-specific, secretory IgA response in saliva relative to pre-booster levels, which is important for conferring mucosal immunity and has the potential to prevent infection and/or transmission of COVID-19.
Avimex interim Phase 3 results showed their NDV-based vaccine, licensed from CastleVax, was effective as a booster against COVID-19.
The Patria® vaccine generates antibodies similar to a vaccine approved by the WHO according to the data available from the Final Stage of Clinical Development, as a booster vaccine.
To date, no serious adverse events related to the application of the vaccine have been observed in the volunteers participating in the protocol; however, research continues to confirm the safety shown since the earlier phases of clinical development.
Information on the clinical advances in the development of Patria® has been shared and will be shared in strict adherence to regulatory processes and national and international standards. The results will be published in peer-reviewed scientific journals upon completion of the protocols that support the robustness of the data obtained.
The industrial scale of the Patria® production processes is accelerated with the aim of obtaining the authorization of the industrial production plants and the vaccine.
GPO announces NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) has entered phase 3 clinical evaluation.
Mr. Anutin Charnweerakul, Deputy Prime Minister of Thailand and the Minister of Public Health announces that GPO’s NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) has entered phase 3 clinical evaluation as a booster dose at Nakhon Phanom Hospital in Nakhon Phanom Province on 20th December 2022. The study is recruiting 4,000 volunteers 18 years of age and older, who were immunized with 2 doses of COVID-19 vaccine as a primary vaccination.
PR: Mount Sinai Announces the Formation of CastleVax Inc., a Clinical-Stage Infectious Diseases Company Targeting Pandemic Threats and Diseases of Unmet Medical Need
The Mount Sinai Health System in New York, NY, has launched CastleVax, Inc. (“CastleVax”), a clinical-stage vaccine research and development company. CastleVax is devoted to the commercial development of the Newcastle disease virus (NDV) vaccine platform technology originally developed in the laboratories of Peter Palese, PhD; Adolfo García-Sastre, PhD; and Florian Krammer, PhD, at the Icahn School of Medicine at Mount Sinai.
Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route
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). 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.
Easier to produce COVID vaccine shows promise in trials; nasal spray vaccine booster works in mice
Reuters "Future of Health" coverage: A COVID-19 vaccine that can be produced locally in low and middle-income countries is yielding promising results in early clinical trials.
The inactivated NDV-HXP-S COVID-19 vaccine induces a significantly higher ratio of neutralizing to non-neutralizing antibodies in humans as compared to mRNAvaccines
Secondary analysis of GPO / Thai Phase 1 trial results. NDV-HXP-S was compared to Pfizer and showed RBD (Receptor Binding Domain) focused response, and higher ratio of neutralizing to non-neutralizing antibodies compared to Pfizer.
A Phase 1/2 Randomized, Placebo-controlled (phase 1) and Active- controlled (phase 2), Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine…
Phase 2 trial results of NDV-HXP-S in Vietnam via the Institute of Vaccines and Medical Biologicals (IVAC). Results show higher concentration of neutralizing Ab in NDV-HXP-S group compared to AstraZeneca group. Phase 3 in planning.
Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomised, Placebo-Controlled, Phase 1/2 Trial
Phase 1 trial results of NDV-HXP-S (NDV with spike protein) in Thailand via the Government Pharmaceutical Organization (GPO). Results show that NDV-HXP-S has an acceptable safety profile and potent immunogenicity.
New York Times: Researchers Are Hatching a Low-Cost Coronavirus Vaccine
A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.