A Phase 1/2a Trial of the Safety, Tolerability and Immunogenicity of PIV5-vectored RSV Vaccine (BLB-201) in RSV Seronegative and Seropositive Infants and Children
Blue Lake Biotechnology Inc.
Summary
This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10\^6 PFU and 10\^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.
Description
This trial is designed to evaluate the safety, tolerability and immunogenicity of BLB-201 vaccine in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection. One (Day 1) or two doses (Day 1 and Day 57) of low (10\^6 PFU) and high dosage (10\^7 PFU) of BLB-201 will be evaluated.
Eligibility
- Age range
- 0–5 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion criteria for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2: Healthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial. Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are n…
Interventions
- BiologicalPIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
- BiologicalPIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
- DrugPlacebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Locations (11)
- Paradigm Clinical ResearchLa Mesa, California
- Paradigm Clinical Research - ModestoModesto, California
- Velocity Clinical Research, BoiseMeridian, Idaho
- Clinical Research PrimeRexburg, Idaho
- AMR NewtonNewton, Kansas
- Velocity Clinical Research - LafayetteLafayette, Louisiana