RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

Summary

A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS). 86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.

Timeline

Start

2016-09

Primary completion

2018-12

Completion

2018-12

Publications

• Jordan E, Lawrence SJ, Meyer TPH, Schmidt D, Schultz S, Mueller J, Stroukova D, Koenen B, Gruenert R, Silbernagl G, Vidojkovic S, Chen LM, Weidenthaler H, Samy N, Chaplin P. Broad Antibody and Cellular Immune Response From a Phase 2 Clinical Trial With a Novel Multivalent Poxvirus-Based Respiratory Syncytial Virus Vaccine. J Infect Dis. 2021 Mar 29;223(6):1062-1072. doi: 10.1093/infdis/jiaa460.

Drugs

Indications