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Virus Therapy
RSV Vaccine for Respiratory Syncytial Virus
Phase 1 & 2
Recruiting
Led By Paul Spearman, MD
Research Sponsored by Blue Lake Biotechnology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-29
Summary
This trial tests a new virus vaccine's safety, tolerability and effectiveness in infants and kids who may have had RSV.
Who is the study for?
This trial is for healthy infants aged 6-24 months and children aged 18-59 months, who have received routine immunizations and are growing normally. They must be available for the duration of the trial, with no history of severe infections or chronic diseases. Children cannot participate if they've had certain vaccines recently, take specific medications, or have immune system problems.
What is being tested?
The study tests two doses of an intranasal RSV vaccine (BLB-201) against a placebo in young children to check safety and immune response. It's randomized and controlled: some kids get the real vaccine at low or high doses; others get a fake treatment (placebo) to compare results.
What are the potential side effects?
While not specified here, typical side effects from vaccines like BLB-201 may include temporary discomfort at the administration site (like stuffy nose), mild fever, fussiness, fatigue, headache, muscle pain, chills or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Solicited Adverse Events
Unsolicited Adverse Events
Trial Design
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFUExperimental Treatment1 Intervention
30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
Group II: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFUExperimental Treatment1 Intervention
32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
Group III: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFUExperimental Treatment1 Intervention
16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
Group IV: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFUExperimental Treatment1 Intervention
6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
Group V: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFUExperimental Treatment1 Intervention
6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
Group VI: Group 4, children (age 8-24 months), RSV+ or RSV-, PlaceboActive Control1 Intervention
16 participants will be administered placebo by intranasal route on Day 1
Group VII: Group 3, children (age 8-24 months), RSV+ or RSV-, PlaceboPlacebo Group1 Intervention
8 participants will be administered placebo by intranasal route on Day 1
Group VIII: Group 6, children (age 8-24 months), RSV+ or RSV-, PlaceboPlacebo Group1 Intervention
15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
Group IX: Group 1, infants (age 18-59 months), RSV+, PlaceboPlacebo Group1 Intervention
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group X: Group 2, infants (age 18-59 months), RSV+, PlaceboPlacebo Group1 Intervention
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Blue Lake Biotechnology Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Paul Spearman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
425 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been in close contact with specific groups after getting vaccinated.I have been hospitalized before due to a severe respiratory virus infection.My child is healthy, aged 18-59 months, and I can consent for them.My child is between 6 to 24 months old and I can consent for them.My child is temporarily ineligible due to a short-term condition.I am up to date with all vaccinations suitable for my age.I haven't received immunoglobulin or antibody treatments in the last 6 months.I have had neurological issues after an infection or vaccination.I am either younger than 6 months or older than 60 months.I was born with a major birth defect like cleft palate.I have a lung condition or asthma.I am receiving treatment for a heart condition.I have been hospitalized for a severe infection before.I have a weakened immune system or have had a bone marrow/solid organ transplant.I have a long-term illness.My child was born prematurely and is under 1 year old.I have not received any RSV antibody treatment in the past year.My child is between 6 to 24 months old.I was born before 34 weeks of pregnancy and am now over 1 year old.My growth in height and weight is normal for my age.I have an autoimmune, inflammatory, vascular, or rheumatic condition.My child is between 18 to 59 months old and has tested positive for the study condition.I have had a severe reaction to a vaccine before.I am currently on immunosuppressive therapy, including steroids.I have not received any blood products in the last 6 months.I am scheduled to receive certain vaccines or medications before or after the trial vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
- Group 2: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
- Group 3: Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
- Group 4: Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
- Group 5: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
- Group 6: Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
- Group 7: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
- Group 8: Group 1, infants (age 18-59 months), RSV+, Placebo
- Group 9: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
- Group 10: Group 2, infants (age 18-59 months), RSV+, Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT05655182 — Phase 1 & 2
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