MVA-BN RSV Vaccine Description
The MVA-BN RSV 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.
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. The incorporation of five antigens differentiates MVA-BN RSV from any other RSV vaccine candidates in development.
The vaccine candidate is based on Bavarian Nordic’s proprietary MVA-BN® platform technology, also used in the Company’s approved vaccines for smallpox and Ebola.
Paul Chaplin, President, and CEO of Bavarian Nordic, commented on September 1, 2021, “We are pleased to report these highly encouraging phase 2, human challenge study results, that are equivalent to, or even better than those of competitor candidates and which confirm the potential of our RSV vaccine candidate."
Denmark-based Bavarian Nordic A/S (OMX: BAVA) is a fully integrated vaccines company focused on the development, manufacturing, and commercialization of life-saving vaccines.
MVA-BN RSV Vaccine Indication
MVA-BN-RSV Vaccine is indicated to prevent RSV (respiratory syncytial virus). RSV is highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in many hospitalizations. RSV infections are also a serious health concern in the elderly and adults with cardiopulmonary disease. RSV is a common virus that usually causes mild, cold-like symptoms, but in serious cases can cause severe lung infections, including bronchiolitis and pneumonia. Those at risk are typically young infants and the elderly, and people with weakened immune systems, says the U.S. CDC.
MVA-BN RSV Vaccine Side Effects
No vaccine-related serious adverse events were observed. The vaccine was well-tolerated, consistent with the safety profile previously reported in phase 1 and phase 2 clinical studies, announced by the company on September 1, 2021.
MVA-BN RSV Vaccine News
September 1, 2021 - Bavarian Nordic A/S (OMX: BAVA) announced results from a human challenge trial of MVA-BN® RSV. 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. Pending further analysis of the current RSV infection rates, discussions with regulatory authorities about the Phase 3 design, and funding/partnering considerations, the Company will determine the immediate next steps and expects to communicate these during the fourth quarter of 2021.
August 8, 2018: Bavarian Nordic announced positive data from the extension study of its Phase 2 study investigating the safety and immune responses of its universal RSV vaccine, MVA-BN® RSV, in an older adult population.
December 14, 2016: Bavarian Nordic announced that it had completed enrollment of 400 subjects in Phase 2 clinical study of MVA-BN® RSV, a novel, broad-spectrum vaccine candidate against RSV (respiratory syncytial virus).
September 29, 2016: Bavarian Nordic announced the presentation of data from a Phase 1 study of its novel, broad-spectrum RSV (respiratory syncytial virus) vaccine candidate, MVA-BN RSV®.
MVA-BN RSV Vaccine Clinical Trials
The Company developed a Phase 3 program, originally planned to start in 2021. It rapidly advanced the clinical development of the vaccine and has 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 the elderly included revaccination of subjects after one year. The immune responses were rapidly and significantly increased, notably in subjects with the weakest immunity before the booster vaccination.
A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN®-RSV Vaccine Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants. Last updated on June 7, 2021.
Clinical Trial NCT02873286: RSV-MVA-BN Vaccine Phase II Trial in ≥ 55-Year-Old Adults. This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN®-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N).