Respiratory Syncytial Virus (RSV) Prevention Research Study

A phase 2b/3 Double-Blind, Randomized, Placebo-controlled Study to evaluate the efficacy of MK-1654 in Healthy Pre-term and Full-term infants

Protocol Description

The purpose of this study is to find out if a single injection of an investigational RSV monoclonal antibody (MK-1654) can prevent RSV infection in infants. MK-1654 is a fully human monoclonal antibody with long-half life that targets the RSV F protein. RSV infection is a common infection among infants less than 2 years of age. RSV can cause cold like symptoms with fever and in some children, it can cause lung infection (bronchiolitis) which can result in breathing difficulty and low oxygen level in the blood and dehydration. Currently there are no approved treatments for prevention of RSV infection in healthy infants. Existing preventive treatment (Palivizumab, Synagis) is targeted towards preterm infants born before 29 weeks of gestation or preterm infants with underlying heart or lung problems.

Eligibility Criteria

This study will enroll healthy Infants with a gestational age of ≥29 weeks born after January 1, 2022, who do not qualify for Synagis (Palivizumab).


Participants will complete 6 study visits over 12 months. Study assessments will include medical history, physical exam, blood tests, buccal and nasopharyngeal swabs. In addition, Infants in the study will be closely monitored for respiratory illness through weekly phone calls during the first 6 months (RSV season). Children with signs and symptoms of possible RSV infection will undergo a nasopharyngeal swab for RSV test.

Visits: 6
Duration: 12 months
Number of blood draw: 3
Buccal swab: 1 time, optional
Nasopharyngeal swab: if there are symptoms and signs of respiratory infection

Status: Open for Enrollment

Source(s) of Support


Primary Investigator

Kumaravel Rajkumar, MD, MS

Contact Information

To get started, please contact
Dr. Kumaravel Rajakumar: email:
Mr. Matt Lee (Study Coordinator): phone: 412-692-7806, email: