Phase 2a RSV Human Challenge Study of MK-4482 in Healthy Participants
Research type
Research Study
Full title
A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-4482 in Healthy Participants Inoculated with Experimental Respiratory Syncytial Virus
IRAS ID
1006129
Contact name
Andrea Schaeffer
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to investigate if an experimental drug called MK-4482 may be useful in preventing and treating Respiratory Syncytial Virus (RSV) infections in healthy adults inoculated with the virus.
RSV spreads from person to person by close contact with infected individuals, through droplets, or through contaminated surfaces . The only approved treatment for RSV infection is a drug called Ribavirin but because of its unwanted side effects, and low effectiveness, it is rarely used. There are vaccines in development for the prevention of RSV, however these are not currently approved for use. Therefore, we need an effective treatment for RSV infection.
Up to 105 volunteers, 18-55 years of age, who consent to the participation in this research will be invited to a Quarantine unit at hVIVO, to stay for approximately 16 days. Participants will be randomly allocated to one of three treatment groups to receive either:
1- MK-4482 prophylactically (as a prevention prior to inoculation with the virus), or
2- MK-4482 as a treatment (after inoculation with the virus), or
3- Placebo.
All participants will receive the study drug or Placebo twice daily for 5 consecutive days, a total of 10 doses.
To test the effect of the study drug, eligible participants will be inoculated with RSV on Study Day 0. Participants will be monitored for safety throughout the study and have assessments performed daily during the quarantine period. Assessments will include nasal samples collected twice daily and symptoms collected 3 times daily using symptom diary cards. After completion of the Quarantine phase, participants will need to return for a final follow up visit approximately 28 days (±3 days) from the date they receive the study virus.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0314
Date of REC Opinion
30 Sep 2022
REC opinion
Further Information Favourable Opinion