MVA-BN RSV / Bavarian Nordic - LARVOL DELTA

Analyzing Differences in Viral Dynamics Between Vaccinated and Unvaccinated RSV Patients. (PubMed, Epidemiologia (Basel)) - " Here, we use data from the MVA-BN-RSV Phase II vaccine study to quantify the dynamical differences between vaccinated and unvaccinated patients challenged with RSV...We also find that vaccinated patients experience a higher response variance than the placebo group. While the differences in viral clearance and basic reproduction number are promising, the high variability in response to the vaccine could leave many vaccinated patients without adequate protection."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

MVA-BN-RSV Vaccine Trial (clinicaltrials.gov) - P3 | N=20419 | Terminated | Sponsor: Bavarian Nordic | Completed ➔ Terminated; The trial was terminated after the first RSV season because of the failure to meet the primary outcome measures of vaccine efficacy

Trial termination • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. (PubMed, Vaccine) - P3 | "The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV...The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022)."

Journal • P3 data • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

MVA-BN-RSV Vaccine Trial (clinicaltrials.gov) - P3 | N=21656 | Completed | Sponsor: Bavarian Nordic | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Sep 2023

Trial completion • Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

MVA-BN-RSV Vaccine Trial (clinicaltrials.gov) - P3 | N=20000 | Active, not recruiting | Sponsor: Bavarian Nordic | Trial primary completion date: Nov 2023 ➔ Jun 2023

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: a Human Challenge Trial of MVA-BN-RSV Vaccine. (PubMed, J Infect Dis) - "MVA-BN-RSV vaccination resulted in lower viral load and symptom scores, fewer confirmed infections, and induced humoral and cellular responses."

Journal • Infectious Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG

MVA-BN-RSV Vaccine Trial (clinicaltrials.gov) - P3 | N=20000 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Development of mRNA vaccines against respiratory syncytial virus (RSV). (PubMed, Cytokine Growth Factor Rev) - "Among these preventive interventions, MVA-BN-RSV, RSVpreF3, RSVpreF, Ad26. RSV.preF, nirsevimab, clesrovimab and mRNA-1345 is being tested in phase 3 clinical trials, and displays the most promising in infant or elderly populations...This review discusses the structure, life cycle, and brief history of RSV, while also presenting the current advancements in RSV preventatives, with a focus on the latest progress in RSV mRNA vaccine development. Finally, future prospects for this field are presented."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immune Responses of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in an RSV Human Challenge Trial (HCT) in Healthy Adult Participants (IDWeek 2022) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Respiratory Syncytial Virus Infections

MVA-BN-RSV Vaccine Trial (clinicaltrials.gov) - P3 | N=20000 | Recruiting | Sponsor: Bavarian Nordic | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults (clinicaltrials.gov) - P2a | N=73 | Completed | Sponsor: Bavarian Nordic | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Phase 3 MVA-BN-RSV Vaccine Efficacy Trial (clinicaltrials.gov) - P3 | N=20000 | Not yet recruiting | Sponsor: Bavarian Nordic

New P3 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults (clinicaltrials.gov) - P2a; N=73; Active, not recruiting; Sponsor: Bavarian Nordic; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults (clinicaltrials.gov) - P2a; N=72; Not yet recruiting; Sponsor: Bavarian Nordic

Clinical • New P2a trial • Infectious Disease • Respiratory Diseases

Broad Antibody and Cellular Immune Response from a Phase 2 Clinical Trial with a Novel Multivalent Poxvirus Based RSV Vaccine. (PubMed, J Infect Dis) - P2 | "MVA-BN-RSV induces a broad immune response that persists at least 6 months and can be boosted at 12 months, without significant safety findings."

Clinical • Journal • P2 data • Respiratory Diseases

RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults (clinicaltrials.gov) - P2; N=420; Active, not recruiting; Sponsor: Bavarian Nordic; Trial completion date: Aug 2018 ➔ Dec 2018; Trial primary completion date: Aug 2018 ➔ Dec 2018

Trial completion date • Trial primary completion date • Biosimilar • Cardiovascular • Dyslipidemia • Reperfusion Injury

Safety and immunogenicity of novel modified vaccinia Ankara-vectored RSV vaccine: A randomized phase I clinical trial. (PubMed, Vaccine) - "No differences were observed between the adult and the older adult groups in safety, reactogenicity or immunogenicity. The study demonstrated that the well tolerated MVA-BN-RSV vaccine candidate induces broad cellular and humoral immune responses, warranting further development."

Clinical • Journal • P1 data

RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults (clinicaltrials.gov) - P2; N=420; Completed; Sponsor: Bavarian Nordic; Active, not recruiting ➔ Completed

Clinical • Trial completion