A Study of BLB-201 RSV Vaccine in Infants and Children
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
1 other identifier
interventional
137
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
December 15, 2025
December 1, 2025
5.4 years
December 8, 2022
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Solicited Adverse Events
Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Day 1-15
Unsolicited Adverse Events
Frequencies and grades of unsolicited AEs during a 28-day period after dosing.
Day 1-29
Study Arms (10)
Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
EXPERIMENTAL6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
Group 1, infants (age 18-59 months), RSV+, Placebo
PLACEBO COMPARATOR4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
EXPERIMENTAL6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, Placebo
PLACEBO COMPARATOR4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
EXPERIMENTAL16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
PLACEBO COMPARATOR8 participants will be administered placebo by intranasal route on Day 1
Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
EXPERIMENTAL32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
ACTIVE COMPARATOR16 participants will be administered placebo by intranasal route on Day 1
Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
EXPERIMENTAL30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
PLACEBO COMPARATOR15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
Interventions
BLB201 10\^6 PFU
BLB201 10\^7 PFU
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \<8 months of age and \>60 months of age at the time of planned vaccine inoculation.
- Born at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment
- Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.
- Maternal history of a positive HIV test before or during pregnancy.
- Maternal history of illicit drug abuse or alcohol abuse.
- Evidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (\< 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)
- Clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by medical history or physical exam. Abnormal pulse oximetry testing during screening for undetected critical congenital heart disease or concern for such by medical history or physical exam.
- Acute or chronic medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
- History of severe infection (e.g., requiring hospitalization).
- Known or suspected impairment of immunological functions, bone marrow/solid organ transplant recipients.
- Receiving immunosuppressive therapy including systemic corticosteroids.
- Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities.
- Suspected or documented developmental disorder, delay, or other developmental problem.
- Cardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.
- Lung disease or reactive airway disease.
- +50 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Paradigm Clinical Research
La Mesa, California, 91942, United States
Paradigm Clinical Research - Modesto
Modesto, California, 95355, United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642, United States
Clinical Research Prime
Rexburg, Idaho, 83440, United States
AMR Newton
Newton, Kansas, 67114, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Jin, MD
Blue Lake Biotechnology Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2022
First Posted
December 19, 2022
Study Start
March 9, 2023
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
July 30, 2028
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 5 years, beginning as soon as possible (but no later than 12 months) after article publication.
- Access Criteria
- Data will be made available to investigators and institutions upon request. Requests should be directed to the Blue Lake Biotechnology Inc authors of the publication(s).
De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.