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RSV

MVA-BN® RSV

PHASE 3 ONGOING


MVA-BN RSV is our product candidate for the prevention of RSV (Respiratory Syncytial Virus). The vaccine incorporates five different RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection.

We have advanced the clinical development of the vaccine and have generated highly promising Phase 2 results, confirming both broad and durable antibody and T cell responses against RSV, as well as mucosal immune responses that may be important for protection against RSV. The Phase 2 program in elderly included a revaccination of subjects after one year, following which the immune responses were rapidly and significantly increased, notably in subjects with the weakest immunity prior to the booster vaccination.

In 2021, a human challenge trial of MVA-BN RSV was conducted. The phase 2 double-blinded, placebo-controlled trial enrolled healthy adult volunteers, 18-50 years of age who were randomized to receive either a single vaccination of MVA-BN RSV or placebo. Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. A total of 61 subjects were evaluable. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies. 

A Phase 3 trial of MVA-BN RSV in older adults was initiated in April 2022. 

The VANIR trial is a global, randomized, double-blind Phase 3 trial of the recombinant MVA-BN RSV vaccine in 20,000 adults aged 60 years and older. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease caused by RSV compared to placebo.

The Phase 3 trial is being conducted at approximately 115 sites across the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023 if the pre-defined number of lower-respiratory tract disease events has occurred.

Ongoing or planned trials

A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN® RSV Vaccine in Adults ≥60 Years of Age.
Locations: USA, Germany
Read more: NCT05238025

RSV (respiratory syncytial virus) has been recognized as a significant cause of respiratory illness in all age groups. It is highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in a high number of hospitalizations. RSV infections are also a serious health concern in the elderly and in adults with cardiopulmonary disease.

According to estimates from WHO, RSV infects more than 64 million people globally each year and causes a similar number of deaths as influenza, yet unlike influenza, there is no vaccine to prevent RSV.

There are only two subtypes of RSV, A and B, which are typically present either simultaneously or alternately during yearly epidemics.

December 22, 2022
Bavarian Nordic Completes Enrollment in Global Phase 3 Trial of RSV Vaccine Candidate for Older Adults
April 20, 2022
Bavarian Nordic Announces Initiation of a Global Phase 3 Clinical Trial of its RSV Vaccine Candidate in Older Adults
February 14, 2022
Bavarian Nordic Announces Breakthrough Therapy Designation for its RSV Vaccine Candidate for the Prevention of Respiratory Syncytial Virus in Older Adults
September 1. 2021
Bavarian Nordic Reports Positive Results from Human Challenge Trial of its RSV Vaccine Candidate
August 8, 2018
Bavarian Nordic Announces Positive Data from Phase 2 Extension Study of its Universal RSV Vaccine
March 6, 2018
Bavarian Nordic Announces Additional Positive Data from a Phase 2 Study of its Universal RSV Vaccine
November 9, 2017
Bavarian Nordic Announces Initiation of Phase 2 Booster Study of its Universal RSV Vaccine
September 21, 2017
Bavarian Nordic Provides Update on its Universal RSV Vaccine
June 27, 2017
Bavarian Nordic Announces Positive Data from Ongoing Phase 2 Study Investigating a Universal RSV Vaccine
February 23, 2017
Updated Phase 1 Data Show Bavarian Nordic’s Vaccine Candidate Induces a Broad and Durable Immune Response against RSV
December 14, 2016
Bavarian Nordic Announces Completion of Enrollment for Phase 2 Clinical Trial of RSV Vaccine
October 18, 2016
Bavarian Nordic Announces Initiation of Phase 2 Clinical Trial of RSV Vaccine
May 23, 2016
Bavarian Nordic Announces Positive Top Line Results from a Phase 1 Trial of a Novel, Broad Spectrum RSV Vaccine in Healthy Adult and Elderly Populations