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Baltimore, Maryland 21205


Purpose:

The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children.


Study summary:

Human RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children. The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of D46cpΔM2-2 vaccine or placebo at study entry (day 0). Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 (RSV-seropositive children) will attend several study visits and will be followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants in Group 2 will also attend several study visits during the time they are enrolled in the study. Study visits for all participants may include clinical assessments, blood collection, and nasal washes.


Criteria:

RSV-Seropositive Children: Inclusion Criteria: - Greater than or equal to 12 months of age and less than 60 months of age - Received routine immunizations appropriate for age - Serum RSV neutralizing antibody titer greater than or equal to 1:40 - Serum RSV neutralizing antibody result obtained this calendar year - Pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 56 days prior to inoculation - Parent/guardian has completed the study comprehension assessment - Parent/guardian has signed the study informed consent document (ICD) - Subject is expected to be available for the duration of the study Exclusion Criteria: - Evidence of chronic disease - Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th) - Known or suspected impairment of immune function - Maternal history of positive HIV test - Bone marrow/solid organ transplant recipient - Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities - Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem - Cardiac abnormality requiring treatment - Lung disease or reactive airway disease - More than one episode of wheezing in the first year of life - Wheezing episode or received bronchodilator therapy within the past 12 months - Previous immunization with an experimental RSV vaccine - Previous receipt or planned administration of anti-RSV antibody product - Previous serious vaccine-associated AE or anaphylactic reaction - Known hypersensitivity to any vaccine component - Previous receipt of immunoglobulin or any antibody products - Previous receipt of any other blood products within the past 6 months - Member of a household that contains an infant who is less than 12 months of age during study days 0 to 10 - Member of a household that includes an immunocompromised individual - Member of a household that includes a person who has received chemotherapy within the past 12 months - Will attend a daycare facility that does not separate children by age and contains an infant who is greater than 12 months of age during study days 0 to 10 RSV-Seronegative Infants and Children: Inclusion Criteria: - Greater than or equal to 6 months of age and less than 25 months of age - Received routine immunizations appropriate for age - Serum RSV neutralizing antibody titer is less than 1:40 - Screening and pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 42 days prior to inoculation - Parent/guardian has completed the study comprehension assessment - Parent/guardian has signed the study ICD - Subject is expected to be available for the duration of the study - Born at greater than or equal to 37 weeks gestation or is currently greater than 1 year of age Exclusion Criteria: - Evidence of chronic disease - Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th) - Known or suspected impairment of immune function - Maternal history of positive HIV test - Bone marrow/solid organ transplant recipient - Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities - Current or unresolved suspected or documented developmental disorder, delay, or other developmental problem - Cardiac abnormality requiring treatment - Lung disease or reactive airway disease - More than one episode of wheezing in the first year of life - Wheezing episode or received bronchodilator therapy within the past 12 months - Previous immunization with an experimental RSV vaccine - Previous receipt or planned administration of anti-RSV antibody product - Previous receipt of immunoglobulin or any antibody products - Previous receipt of any other blood products within the past 6 months - Previous serious vaccine-associated AE or anaphylactic reaction - Known hypersensitivity to any vaccine component - Member of a household which contains an infant who is less than 6 months of age during study days 0 to 28 - Member of a household that includes an immunocompromised individual - Member of a household that includes a person who has received chemotherapy within the past 12 months - Will attend a daycare facility that does not separate children by age and contains an infant who is less than 6 months of age during study days 0 to 28 Temporary Exclusion Criteria for RSV-Seropositive and RSV-Seronegative Children: To be eligible to participate, RSV-seropositive and RSV-seronegative infants and children must satisfy none of the temporary exclusion criteria. The following conditions are temporary or self-limiting. Once the condition is resolved and the subject is otherwise eligible, the subject may be enrolled or rescreened, if necessary. - Any of the following events at the time of inoculation: - fever (rectal temperature of greater than or equal to 100.4°F), - upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) - nasal congestion significant enough to interfere with successful inoculation - otitis media - Receipt of any killed vaccine or live-attenuated rotavirus vaccine less than 14 days prior to inoculation - Receipt of the following medications less than 28 days prior to inoculation: - any live vaccine other than rotavirus - another investigational vaccine or investigational drug, - systemic corticosteroids administered for greater than 14 days at a dosage equivalent to prednisone at greater than 2 mg/kg or 20 mg daily - salicylate (aspirin) or salicylate-containing products - Receipt of a non-permitted concomitant medication or any of the following medications less than 3 days prior to inoculation: - systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, - intranasal medications - Scheduled administration of the following in relation to planned inoculation: - killed vaccine within the 14 days following, - any live vaccine other than rotavirus within the 28 days following, - another investigational vaccine or drug within the 28 days following for RSV-seropositive children and the 56 days following for RSV-seronegative infants and children


NCT ID:

NCT02601612


Primary Contact:

Principal Investigator
Ruth A. Karron, MD
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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