NCT02794870

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID ΔM2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 311.

Detailed description

Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness in infants and children under 5 years of age worldwide. This study evaluated the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6 to 24 months of age. Participants were randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s vaccine or placebo (administered as nose drops) at study entry (Day 0). Participants could be enrolled in the study between April 1 and October 14 (outside of RSV season) and remained on study until they completed the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants' total study duration was between 6 to 10 months, depending on when they enrolled in the study. Participants attended several study visits throughout the study, which included blood collection, nasal washes, and/or physical examinations. Participants' parents or guardians were contacted by study staff at various times during the study to monitor participants' health.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSV LID ΔM2-2 1030s vaccine	10\^5.0 PFU; administered as nose drops
BIOLOGICAL	Placebo	Isotonic diluent, administered as nose drops

Timeline

• Start date: 2016-07-15
• Primary completion: 2017-07-07
• Completion: 2017-07-07
• First posted: 2016-06-09
• Last updated: 2018-08-27
• Results posted: 2018-08-27

Locations

8 sites across 1 country: United States