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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
73
MVA-BN-RSV (nominal titre 5 x10\*8 Inf.U per 0.5 mL) as intramuscular injections. Liquid frozen suspension, single dose of 0.5ml.
TBS (Placebo) as intramuscular injections (0.5ml)
hVIVO Services Limited
London, United Kingdom
Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b
Median VL-AUC of RSV-A Memphis 37b as determined by qRT-PCR from nasal washes collected twice daily
Time frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Peak viral load of RSV-A Memphis 37b
Peak viral load of RSV-A Memphis 37b is defined by the maximum viral load in nasal washes
Time frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Total clinical symptom score (TSS)
Total clinical symptom score (TSS) determined as the sum of the scores as collected on the participants' symptom diary cards, collected three times daily.
Time frame: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Percentage of participants with RT-PCR-confirmed RSV infection
RT-PCR-confirmed RSV infection \[at least two detectable (≥LLOD) qRT-PCR measurements (reported on 2 or more consecutive days), starting two days post-viral challenge (Day 2) up to discharge from Quarantine\], AND 1 or more positive clinical symptoms of Grade 2 or more from any category in the symptom scoring system (Upper Respiratory, Lower Respiratory, Systemic)
Time frame: From Day 2 up to discharge from Quarantine (Day12)
Weight of mucus produced
Median AUC of mucus weight produced
Time frame: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Occurrence of solicited local reactions and systemic events
Local reactions (pain, swelling, redness, induration, itching) and systemic events (including body temperature)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From day of vaccination (Day-28) and 7 subsequent days) after vaccination
Occurrence of unsolicited adverse events (AEs)
Unsolicited AEs are defined as AEs observed by the participant or investigator which are not pre-listed on the memory aid card/symptom score card
Time frame: Between vaccination (Day-28) and inoculation with RSV Memphis 37b (Day0)
Occurrence of medically attended AEs (MAEs)
A medically attended adverse event (MAE) is an adverse event, whether considered related to the investigational vaccine or not, that led to the participant seeking evaluation by a healthcare provider
Time frame: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Serious adverse events (SAEs)
SAEs are defined as any untoward medical occurrence that at any dose: results in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, is an important medical event
Time frame: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Occurrence of unsolicited AEs
Unsolicited AEs are defined as AEs observed by the participant or investigator which are not pre-listed on the memory aid card/symptom score card
Time frame: From Day 0 up to Day 28 follow up
Occurrence of SAEs
Occurrence of SAEs related to the viral challenge
Time frame: From Day 0 up to Day 28 follow up