VLA 2001 / Valneva, Dynavax - LARVOL DELTA

Heterologous prime-boost vaccination with VLA2001 and an ORFV-based vector enhances spike- and nucleocapsid-specific immunity in mice. (PubMed, Front Immunol) - "These findings highlight the immunological synergy between inactivated whole-virus and ORFV vector vaccines and support the strategic use of Prime-2-CoV as a potent heterologous booster. The ORFV platform's favorable safety profile and Th1-polarizing capacity make it a valuable candidate for future heterologous vaccine strategies beyond SARS-CoV-2."

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

Immunogenicity and efficacy of VLA2001 vaccine against SARS-CoV-2 infection in male cynomolgus macaques. (PubMed, Commun Med (Lond)) - "We demonstrate that the VLA2001 adjuvanted vaccine is immunogenic both in mouse and NHP models and prevent cynomolgus macaques from the viruses responsible of COVID-19."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years (clinicaltrials.gov) - P3 | N=306 | Completed | Sponsor: Valneva Austria GmbH | Active, not recruiting ➔ Completed

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

Safety and Immunogenicity against Ancestral, Delta and Omicron Virus Variants Following a Booster Dose of an Inactivated Whole-Virus COVID-19 Vaccine (VLA2001): Interim analysis of an open-label extension of the randomized, controlled, phase 3 COV-COMPARE trial. (PubMed, J Infect) - P3 | "A booster dose of VLA2001 was safe and well tolerated after primary immunization with VLA2001 and ChAdOx1-S. The tolerability of a booster dose of VLA2001 was similar to the favourable profile observed after the first and second priming doses. Both in a homologous and a heterologous setting, boosting resulted in higher neutralizing antibody titres than after primary immunization and significant increases in cross-neutralization titres against Delta and Omicron were observed after the booster dose. These data support the use of VLA2001 in booster programmes in ChadOx1-S primed groups."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection (clinicaltrials.gov) - P2/3 | N=178 | Completed | Sponsor: Valneva Austria GmbH | Active, not recruiting ➔ Completed | N=275 ➔ 178

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

Evaluating the reactogenicity of COVID-19 vaccines from network-meta analyses. (PubMed, Expert Rev Vaccines) - "A systematic literature review identified 24 records reporting solicited adverse events for AZD1222, BNT162b2, mRNA-1273, NVX-Cov2373, and VLA2001 in individuals aged 16 or older. VLA2001 had the highest likelihood of being the least reactogenic vaccine after the first and second vaccine dose, especially for systemic adverse events after the first dose. The reduced chance of experiencing an adverse event with some COVID-19 vaccines may help to overcome vaccine hesitancy in population groups with concerns about the side effects of vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease

COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222 (clinicaltrials.gov) - P3 | N=4034 | Completed | Sponsor: Valneva Austria GmbH | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Mar 2023

Head-to-Head • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Inactivated Heterologous Booster Vaccination (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Centro de Estudios en Infectogía Pediatrica | N=100 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • IL2

VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection (clinicaltrials.gov) - P2/3 | N=275 | Active, not recruiting | Sponsor: Valneva Austria GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ May 2023

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

"#iNCOVACC #bbv154 #Covaxin #bbv152 @BharatBiotech @Ocugen #Ocu500 @valnevaSE #vla2001" (@JessGarcaGutir2)

COVID-19 Paediatric VLA2001-321 Study (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Valneva Austria GmbH | N=1720 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

"Stop Mrna!!! Only valneva vla2001" (@schamifix)

Overview of COVID-19 vaccines licensed in the EU-from technology via clinical trial to registration (PubMed, Bundesgesundheitsblatt Gesundheitsforschung Gesund) - "These include two mRNA-based vaccines (BNT162b2, Comirnaty® and mRNA-1273, Spikevax®), two adenoviral vector-based vaccines (AZD1222, Vaxzevria® and Ad26.COV2.S, Jcovden®), the subunit vaccine Nuvaxovid® (NVX-CoV2373), and the inactivated virus vaccine VLA2001. Although these vaccines are based on different technologies, they all share the use of the spike protein of SARS-CoV‑2 as antigen.This overview describes the characteristics of their composition, their efficacy, and the impact of various factors on efficacy. Another aspect of this overview is the description of the approval process and the identification of factors that have contributed to the unprecedented speed in the development and approval of vaccines against a pandemic pathogen."

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

COV-COMPARE: Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (clinicaltrials.gov) - P3 | N=4034 | Active, not recruiting | Sponsor: Valneva Austria GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Inactivated Heterologous Booster Vaccination (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Centro de Estudios en Infectogía Pediatrica

New P3 trial • Infectious Disease • Novel Coronavirus Disease • IL2

Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in the UK (COV-COMPARE): interim analysis of a randomised, controlled, phase 3, immunobridging trial. (PubMed, Lancet Infect Dis) - P3 | "VLA2001 has a favourable tolerability profile and met superiority criteria for neutralising antibodies and non-inferiority criterion for seroconversion rates compared with ChAdOx1-S. The data presented here formed the basis of successful marketing approval for use of VLA2001 in primary vaccination in the EU, the UK, Bahrain, and United Arab Emirates."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"OMS recommande le vaccin anti Covid-19 #vla2001 de chez #valneva À quand son utilisation en France @SKyriakidesEU @vonderleyen @EmmanuelMacron" (@conkiencang)

Infectious Disease • Novel Coronavirus Disease

COV-COMPARE: Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (clinicaltrials.gov) - P3 | N=4679 | Recruiting | Sponsor: Valneva Austria GmbH | Trial completion date: Jul 2023 ➔ Sep 2024 | Trial primary completion date: Jul 2022 ➔ Nov 2022

Head-to-Head • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Paediatric VLA2001-321 Study (clinicaltrials.gov) - P2/3 | N=1720 | Not yet recruiting | Sponsor: Valneva Austria GmbH | Trial completion date: Apr 2025 ➔ Aug 2025 | Initiation date: Jun 2022 ➔ Oct 2022 | Trial primary completion date: Mar 2023 ➔ Jul 2023

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

VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection (clinicaltrials.gov) - P2/3 | N=275 | Recruiting | Sponsor: Valneva Austria GmbH | Phase classification: P3 ➔ P2/3 | N=150 ➔ 275 | Trial completion date: Jul 2023 ➔ Oct 2023

Enrollment change • Phase classification • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of the inactivated whole-virus adjuvanted vaccine VLA2001: a randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults. (PubMed, J Infect) - P1/2 | "VLA2001 was well tolerated in all tested dose groups, and no safety signal of concern was identified. The highest dose group showed statistically significantly stronger immunogenicity with similar tolerability and safety, and was selected for phase 3 clinical development."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • IFNG

COV-COMPARE: Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (clinicaltrials.gov) - P3 | N=4679 | Recruiting | Sponsor: Valneva Austria GmbH | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Feb 2022 ➔ Jul 2022

Head-to-Head • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"$VALN EMA accepts MAA for inactivated #COVID19 vaccine candidate, VLA2001" (@BioStocks)

Clinical • Infectious Disease • Novel Coronavirus Disease

"#Valneva and #Synairgen remain #Covid laggards (Via @JacobPlieth) #VLA2001 #SNG001 https://t.co/vKjkW58YfB" (@evaluatevantage)

Novel Coronavirus Disease

"But What about vla 2001 vs co vid and the fu#### EMA ?" (@defre0566)