Butanvac (Coronavirus Vaccine) / Oswaldo Cruz Foundation, Butantan Institute - LARVOL DELTA

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Sean Liu | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Apr 2024

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Mucosal multivalent NDV-based vaccine provides cross-reactive immune responses against SARS-CoV-2 variants in animal models. (PubMed, Front Immunol) - "Furthermore, intranasal trivalent live NDV-HXP-S boosted systemic and mucosal immunity in mice pre-immunized with mRNA vaccine. Overall, a mucosal multivalent live NDV-HXP-S vaccine shows great promise as a safe, next-generation vaccine conferring broad mucosal and systemic immunity against future SARS-CoV-2 variants."

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

Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil. (PubMed, Vaccine) - P1 | "This is a single-center, randomized, double-blind, active-controlled dose-escalating phase I clinical trial to evaluate the immunogenicity and safety of NDV-HXP-S (1 μg, 3 μg, and 10 μg), an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus (NDV) expressing stabilized pre-fusion S protein from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)...The vaccine also displayed a very favorable safety profile. ClinicalTrials.gov,NCT04993209."

Clinical • Journal • P1 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine (clinicaltrials.gov) - P2/3 | N=4400 | Completed | Sponsor: Butantan Institute | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A single immunization with intranasal Newcastle disease virus (NDV)-based XBB.1.5 variant vaccine reduces disease and transmission in animals against matched-variant challenge. (PubMed, Vaccine) - "Furthermore, one or two intranasal vaccinations with NDV-HXP-S XBB.1.5 protected hamsters from variant matched infection and reduced virus emission, thereby providing complete protection to naïve animals in a direct contact transmission study. The data shown in this study supports the notion that intranasal vaccination with variant-adapted NDV-HXP-S induces protective mucosal immunity and reduces transmission rates, highlighting the robust protective efficacy of a single mucosal vaccination in mice and hamsters."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. (PubMed, Vaccine) - "NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Considering that induction of neutralising antibodies against SARS-CoV-2 has been correlated with the efficacy of COVID-19 vaccines, including VAXZEVRIA, our results suggest that vaccination with COVIVAC may afford clinical benefit matching or exceeding that of the VAXZEVRIA vaccine. ClinicalTrials.govNCT05940194."

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

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Sean Liu | Trial completion date: Apr 2024 ➔ Nov 2025

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of multidose thermotolerant formulations of a vector-based Covid-19 vaccine candidate, NDV-HXP-S in different product formats: Stability and preservative efficacy study. (PubMed, Vaccine X) - "Lead lyophilized vaccine formulations were identified which were able to maintain S-antigen content for six months at 2 °C to 8 °C, 25 °C, and 40 °C. Both the liquid and lyophilized formulations identified are improved thermotolerant SARS-CoV-2 vaccine formulations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Intranasal SARS-CoV-2 Omicron variant vaccines elicit humoral and cellular mucosal immunity in female mice. (PubMed, EBioMedicine) - "We demonstrate that NDV-HXP-S Omicron variant vaccines utilised for primary immunizations or boosting efficiently elicit humoral and cellular immunity. The described induction of systemic and mucosal immunity has the potential to reduce infection and transmission."

Journal • Preclinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Sean Liu | Trial primary completion date: Apr 2024 ➔ May 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of a quantitative ELISA for SARS-CoV-2 vaccine candidate, NDV-HXP-S, with CpG 1018® adjuvant. (PubMed, Hum Vaccin Immunother) - "The vaccine was mixed with and without CpG 1018® adjuvant in saline and maintained S-antigen content at 2°C to 8°C for the entire 6-month period. Additionally, a pilot controlled temperature chain (CTC) stability study was conducted at the completion of the 6-month study and demonstrated the possibility for this vaccine candidate to attain CTC stability labeling."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effect of homologous or heterologous vaccine booster over two initial doses of inactivated COVID-19 vaccine. (PubMed, Expert Rev Vaccines) - "Immune responses generated after one dose of heterologous boost were high and able to preventing severity of disease and symptomatic infection. New approach of inactivated vaccine has been developed using inactivating recombinant vector virus-NDV-HXP-S vaccine."

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

NDV-HXP-S, a COVID-19 vaccine to boost mucosal immunity. (ESWI 2023) - No abstract available

Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease

Trivalent NDV-HXP-S Vaccine Protects against Phylogenetically Distant SARS-CoV-2 Variants of Concern in Mice (ESWI 2023) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine (clinicaltrials.gov) - P2/3 | N=4400 | Active, not recruiting | Sponsor: Butantan Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Sep 2024

Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

ADAPTCOV: Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil (clinicaltrials.gov) - P1 | N=320 | Completed | Sponsor: Butantan Institute | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

NDV-HXP-S Vaccine Clinical Trial (COVIVAC) (clinicaltrials.gov) - P2 | N=374 | Completed | Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam

New P2 trial • Infectious Disease • Novel Coronavirus Disease

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

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Sean Liu | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine (clinicaltrials.gov) - P2/3 | N=4400 | Recruiting | Sponsor: Butantan Institute | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Feb 2023

Enrollment open • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

"#Coronavirus - Günstige Covid-Impfung rückt näher - Wiener Zeitung Online - via @Wienerzeitung #NDV_HXP_S @florian_krammer https://t.co/JLUVwBtZkR" (@Fred_S_at)

Infectious Disease • Novel Coronavirus Disease

An inactivated NDV-HXP-S COVID-19 vaccine elicits a higher proportion of neutralizing antibodies in humans than mRNA vaccination. (PubMed, Sci Transl Med) - "The SARS-CoV-2 neutralizing and spike protein binding activity of NDV-HXP-S postvaccination serum samples was compared to that of samples from mRNA BNT162b2 (Pfizer) vaccinees. This finding may explain the high proportion of neutralizing antibodies. In conclusion, vaccination with inactivated NDV-HXP-S induces a high proportion of neutralizing antibodies and absolute neutralizing antibody titers that are comparable to those elicited by mRNA vaccination."

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

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Sean Liu | Trial completion date: Jul 2023 ➔ Mar 2024 | Trial primary completion date: Jul 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand (clinicaltrials.gov) - P1/2 | N=455 | Completed | Sponsor: Mahidol University | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Sep 2022 | Trial primary completion date: Dec 2023 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand (clinicaltrials.gov) - P1/2 | N=460 | Recruiting | Sponsor: Mahidol University | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases