A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy RSV and PIV3 Seropositive 1-9 Year-Old Children
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- MedImmune LLC
- Enrollment
- 120
- Locations
- 11
- Primary Endpoint
- To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.
Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening. MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be stratified by site. This study will enroll during the RSV off season at multiple sites in the United States and Chile.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 1 through 9 years old
- •In general good health
- •Seropositive for RSV (enzyme-linked immunosorbent assay \[ELISA\] titer \> 12 U/ml) and PIV3 (hemagglutination-inhibition \[HAI\] titer \> 1:8)
- •Subject's parent/legal representative available by telephone
- •Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
- •Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
- •Ability to complete the follow-up period of 6 months following dosing as required by the protocol
Exclusion Criteria
- •Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
- •Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
- •Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
- •Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
- •Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
- •Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
- •Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
- •Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
- •History of Guillain-Barré syndrome
- •Known or suspected immunodeficiency, including HIV
Outcomes
Primary Outcomes
To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
Time Frame: Day 28
Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
Time Frame: Day 28 post final vaccination
Adverse events (AEs) from administration of study vaccine through 28 post-dosing
Time Frame: Day 28 post final vaccination
Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing
Time Frame: Day 180
Secondary Outcomes
- To describe the immunogenicity and viral shedding of MEDI-534(Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.)
- The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples(Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.)