Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children.
This study is a companion study to IMPAACT 2000.
|Respiratory Syncytial Virus Infections||Biological: RSV LID ΔM2-2 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 LID ΔM2-2, Lot RSV#007A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age|
- Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study, the first 28 days after inoculation [ 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 Day 56 ]Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).
- Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study, the first 28 days after inoculation [ Time Frame: Measured through Day 28 ]
|Study Start Date:||September 2014|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: RSV LID ΔM2-2 Vaccine
Participants will receive one dose of the RSV LID ΔM2-2 vaccine at study entry, delivered as nose drops.
Biological: RSV LID ΔM2-2 Vaccine
10^5.0 plaque forming units (PFU); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
Placebo Comparator: Placebo Vaccine
Participants will receive one dose of placebo at study entry, delivered as nose drops.
Biological: Placebo Vaccine
0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age in the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. Severe RSV disease in infancy may also predispose children to develop reactive airway disease during childhood. The purpose of this study is to evaluate the safety and immunogenicity of an RSV vaccine (RSV LID ΔM2-2) in RSV-seronegative infants and children at least 6 months and through 24 months of age.
To determine study eligibility, the screening process will include a blood collection. At study entry, eligible participants will be randomly assigned to receive one dose of either the RSV vaccine or placebo, which will be delivered as nose drops. Participants will also undergo a review of medical history, clinical assessment, and a nasal wash. They will then receive their assigned vaccine and will remain under observation for monitoring for 30 minutes after receiving the vaccine. Additional study visits will occur at Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. These visits will include clinical assessments and nasal washes; on Day 56, a blood collection will also occur. On days where no study visit is scheduled (through Day 27), participants' parents or guardians will report participants' temperatures and signs of illness to researchers by e-mail or phone.
In October following vaccination, participants may have a pre-RSV season blood collection visit. During RSV season, November through March following vaccination, researchers will contact participants' parents or guardians on a weekly basis for follow-up monitoring. During this time frame, participants seen by a medical provider for fever, respiratory illness, or otitis media will have a study visit, which will include a nasal wash and clinical assessment. In April following vaccination, participants will undergo a final blood collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040831
|United States, Maryland|
|Center for Immunization Research, JHU|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ruth A. Karron, MD||Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)|