A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months o… (NCT02296463) | Clinical Trial Compass
CompletedPhase 1
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age
Canada32 participantsStarted 2014-11
Plain-language summary
This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and \<72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be excluded if titers for either RSV/A or RSV/B are \<1:16 (4 log2).
Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and in one group placebo) will be used to maintain the study blind; all subjects will receive a complete course of hepatitis A vaccine as a study benefit.
Who can participate
Age range24 Months – 72 Months
SexALL
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Inclusion criteria
✓. Healthy males and females, ≥24 months of age and \<72 months of age, without known chronic cardiopulmonary disease including especially persistent or frequently recurrent wheezing.
✓. Free of other illnesses that are believed to increase the risks associated with influenza or other respiratory viral infections, including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
✓. Parent(s)/guardian(s) willing and able to give informed consent prior to study enrollment, and assert ability to comply with study requirements.
✓. Parent(s)/guardian(s) and/or other designated child care provider must have continuous capacity for telephone communication with the study site.
Exclusion criteria
✕. Serum MN titers against RSV/A or RSV/B \<1:16 (4 log2).
✕. Toxicity grade ≥2 for any safety laboratory parameter.
✕. Participation in research involving an investigational product (drug/biologic/device) within 45 days before planned date of first vaccination and planned participation at any time during the study.
What they're measuring
1
Numbers and percentages of subjects with solicited local and systemic AEs.
Timeframe: Up to Day 392
2
Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample.
✕. Receipt of any vaccine (other than the influenza vaccine specified in the protocol) in the four weeks preceding the first study vaccination and/or planned receipt of a licensed vaccine (other than the hepatitis A vaccine specified in the protocol) at any time prior to Study Day 56.
✕. Receipt of an RSV vaccine at any time.
✕. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
✕. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥1 mg/kg of prednisone per day or equivalent. The use of topical glucocorticoids for minor cutaneous symptoms will be permitted, but the use of nasal or inhaled glucocorticoids in exclusionary (because of potential related diagnoses rather than immunosuppression).