Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02237209|
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : October 8, 2015
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 CIR 291.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infections||Biological: RSV LID ΔM2-2 Vaccine Biological: Placebo Vaccine||Phase 1|
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. Screening may begin after the RSV season (i.e., as of April 1) and enrollment must precede the RSV season (no later than October 14). 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 29), 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I Study of the Safety and Immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2 in RSV-Seronegative Infants and Children|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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)
- 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 ]
- 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 ]
- Frequency of vaccine-related lower respiratory illness [ Time Frame: Measured through Day 56 ]
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237209
|United States, California|
|Usc La Nichd Crs|
|Alhambra, California, United States, 91803|
|University of California, UC San Diego CRS|
|La Jolla, California, United States, 92093-0672|
|United States, Colorado|
|Univ. of Colorado Denver NICHD CRS|
|Aurora, Colorado, United States, 80045|
|United States, Illinois|
|Rush Univ. Cook County Hosp. Chicago NICHD CRS|
|Chicago, Illinois, United States, 60612|
|Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS|
|Chicago, Illinois, United States, 60614-3393|
|United States, Maryland|
|Johns Hopkins University Center for Immunization Research|
|Baltimore, Maryland, United States, 21205|
|United States, Tennessee|
|St. Jude Children's Research Hospital CRS|
|Memphis, Tennessee, United States, 38105-3678|
|Study Chair:||Elizabeth McFarland, MD||Children's Hospital Colorado|