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

Bavarian Nordic1 site in 1 country73 target enrollmentFebruary 22, 2021

ConditionsRSV Infection

InterventionsMVA-mBN294B Placebo

DrugsPlacebo

Overview

Phase: Phase 2
Intervention: MVA-mBN294B
Conditions: RSV Infection
Sponsor: Bavarian Nordic
Enrollment: 73
Locations: 1
Primary Endpoint: Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 22, 2021

End Date

November 2, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bavarian Nordic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•An informed consent document signed and dated by the participant and the Investigator
•Aged between 18 and 50 years old on the day of signing the consent form
•In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the Investigator
•A documented medical history prior to enrolment
•The following criteria are applicable to female participants participating in the study.
•Females of childbearing potential must have a negative pregnancy test prior to enrolment.
•Females of non-childbearing potential:
•Post-menopausal\* females; defined as having a history of amenorrhea for \>12 months with no alternative medical cause, and /or by FSH level \>40mLU/mL, confirmed by laboratory.
•Documented status as being surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomyhysterectomy, bilateral salpingectomy and bilateral oophorectomy)
•The following criteria apply to female and male participants:

Exclusion Criteria

•History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
•Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
•And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations (e.g autoimmune disease or immunodeficiency).
•Participants who have smoked ≥10 pack years at any time \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\].
•A total body weight ≤50 kg or Body Mass Index (BMI) ≤18 kg/m2 or ≥35kg/m
•Females who:
•Are breastfeeding, or
•Have been pregnant within 6 months prior to the study.
•History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug or vaccine, as assessed by the PI.
•Venous access deemed inadequate for the phlebotomy and cannulation demands of the study

Arms & Interventions

Group1: MVA-BN-RSV

Participants will receive one intramuscular injection of MVA-BN-RSV (nominal titre 5 x 10\*8 Inf.U per 0.5 mL) given on day -28 before RSV challenge on day 0. On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants

Intervention: MVA-mBN294B

Group 2: Placebo

Participants will receive one intramuscular injection of Tris-Buffered-Saline (0.5 mL) given on day -28 before RSV challenge on day 0. On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants

Intervention: Placebo

Outcomes

Primary Outcomes

Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b

Time Frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).

Median VL-AUC of RSV-A Memphis 37b as determined by qRT-PCR from nasal washes collected twice daily

Secondary Outcomes

Occurrence of medically attended AEs (MAEs)(From vaccination (Day -28) up to study end (Day 155 (±14 days)).)
Serious adverse events (SAEs)(From vaccination (Day -28) up to study end (Day 155 (±14 days)).)
Occurrence of unsolicited AEs(From Day 0 up to Day 28 follow up)
Occurrence of SAEs(From Day 0 up to Day 28 follow up)
Peak viral load of RSV-A Memphis 37b(From Day 2 post-viral challenge up to discharge from Quarantine (Day12).)
Total clinical symptom score (TSS)(From Day 1 post-viral challenge up to discharge from Quarantine (Day12).)
Percentage of participants with RT-PCR-confirmed RSV infection(From Day 2 up to discharge from Quarantine (Day12))
Occurrence of solicited local reactions and systemic events(From day of vaccination (Day-28) and 7 subsequent days) after vaccination)
Weight of mucus produced(From Day 1 post-viral challenge up to discharge from Quarantine (Day12).)
Occurrence of unsolicited adverse events (AEs)(Between vaccination (Day-28) and inoculation with RSV Memphis 37b (Day0))