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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 5
Healthy Volunteers: t
View:

• 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 not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.

• Sero+ for RSV as defined by serum RSV antibody titer assay

• Participant is expected to be available for the duration of the trial.

• The LAR confirms that the subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.

• Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age.

• Healthy children at least 8 months but less than 25 months of age whose 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 not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.

• Sero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.

• Participant is expected to be available for the duration of the trial.

• The LAR confirms that subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.

• Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND

• If \<1 year of age: has a current height and weight above the 5th percentile for age.

• If ≥1 year of age: has a current height and weight above the 3rd percentile for age.

Locations
United States
California
Paradigm Clinical Research
RECRUITING
La Mesa
Paradigm Clinical Research - Modesto
RECRUITING
Modesto
Idaho
Velocity Clinical Research, Boise
RECRUITING
Meridian
Clinical Research Prime
RECRUITING
Rexburg
Kansas
AMR Newton
RECRUITING
Newton
Louisiana
Velocity Clinical Research - Lafayette
RECRUITING
Lafayette
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Ohio
Velocity Clinical Research, Cleveland
RECRUITING
Beachwood
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Texas
Velocity Clinical Research, Austin
RECRUITING
Cedar Park
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Henry Radziewicz, MD PhD
HRadziewicz@bluelakebiotechnology.com
585-313-0027
Backup
Nubia Kaba
nkaba@cyanvacllc.com
585-313-0027
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2026-12-23
Participants
Target number of participants: 137
Treatments
Experimental: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
Placebo_comparator: Group 1, infants (age 18-59 months), RSV+, Placebo
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Experimental: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
Placebo_comparator: Group 2, infants (age 18-59 months), RSV+, Placebo
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Experimental: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
Placebo_comparator: Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
8 participants will be administered placebo by intranasal route on Day 1
Experimental: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
Active_comparator: Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
16 participants will be administered placebo by intranasal route on Day 1
Experimental: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
Placebo_comparator: Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
Related Therapeutic Areas
Sponsors
Leads: Blue Lake Biotechnology Inc.

This content was sourced from clinicaltrials.gov

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