Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|Respiratory Syncytial Virus Infections||Biological: RSV cps2 Vaccine Biological: Placebo Vaccine||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age|
- Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) [ Time Frame: Measured through Day 28 ]
- Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination [ Time Frame: Measured through study follow-up period, up to 1 year after study entry ]Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).
|Study Start Date:||October 2013|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: RSV cps2 Vaccine
Participants will receive one dose of the RSV cps2 vaccine administered as nose drops at study entry.
Biological: RSV cps2 Vaccine
10^5.3 plaque forming units (PFUs) of RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
Placebo Comparator: Placebo
Participants will receive one dose of placebo administered as nose drops at study entry.
Biological: Placebo Vaccine
Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age around the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. This study will evaluate the safety and immunogenicity of an RSV vaccine in healthy RSV-naïve children.
At study entry, participants will undergo a medical history review, physical examination, blood collection, and a nasal wash. Participants will be randomly assigned to receive the RSV vaccine or placebo at a 2:1 ratio, to be administered as nose drops. Subjects will be actively monitored for 28 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days when no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up. At a study visit on Day 56, participants will undergo a medical history review, blood collection, and a nasal wash procedure.
From November through March following each subject's study participation, parents or guardians will report respiratory and/or febrile illnesses on a weekly basis via telephone calls to study researchers. Participants may have additional study visits that may include blood collection and/or nasal wash procedures during this follow-up period.
This protocol is a companion study to P1114; a study being conducted by the Center for Immunization Research (CIR, Johns Hopkins, Baltimore), and the Laboratory of Infectious Diseases (NIAID, Bethesda). The protocols have identical primary and secondary objectives; immunization schedules; evaluation assays and schedules; safety monitoring and reporting. The protocols will vary slightly in site selection requirements, eligibility requirements and site monitoring. These are all operational issues modified to account for the IMPAACT sites' operations and infrastructure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01852266
|United States, Maryland|
|Johns Hopkins University, Center for Immunization Research (CIR)|
|Baltimore, Maryland, United States, 21505|
|Johns Hopkins University, Center for Immunization Research South|
|Laurel, Maryland, United States, 20708|
|Principal Investigator:||Ruth A. Karron, MD||Johns Hopkins Bloomberg School of Public Health|