RSV Vaccine for Respiratory Syncytial Virus

Recruiting at 15 trial locations

Overseen By Nubia Kaba

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Blue Lake Biotechnology Inc.

Must not be taking: Immunosuppressants, Systemic steroids, Intranasal meds, others

Disqualifiers: Chronic disease, Pulmonary abnormality, Neurological conditions, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

137 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new RSV (Respiratory Syncytial Virus) vaccine called BLB-201, administered through the nose. Researchers aim to determine the vaccine's safety and effectiveness in infants and young children. Participants may receive one of two doses of the vaccine or a placebo (a substance with no treatment effect). The trial suits healthy children aged 8 to 59 months who have had routine vaccinations and no recent severe infections. As a Phase 1 and Phase 2 trial, it focuses on understanding the vaccine's function in people and measuring its effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial allows certain medications like nutritional supplements, medications for acid reflux, eye drops, and topical treatments. However, you cannot take systemic antibiotics, antivirals, antifungals, antiparasitics, or steroids within 7 days before and after the vaccine. Check with the trial team about your specific medications.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that BLB-201, a nasal spray vaccine for RSV, appears safe. In earlier studies, children tolerated it well, and no major safety issues emerged after just one dose. This suggests the vaccine does not cause serious side effects, which is promising for its safety.

Additionally, the safety profile of BLB-201 is similar to other nasal spray vaccines, which are generally safe. These findings suggest that joining the trial could be beneficial, as current data indicates BLB-201 is safe for people so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BLB-201 for RSV because it offers a unique delivery method and potential benefits over existing treatments. Unlike traditional RSV treatments like palivizumab, which is an injectable monoclonal antibody, BLB-201 is administered intranasally, making it potentially easier and more comfortable for young children. This method directly targets the respiratory system, where RSV infections begin, which might enhance its effectiveness in preventing or reducing the severity of RSV infections. Additionally, BLB-201 uses a live-attenuated virus, which could stimulate a strong immune response, potentially providing longer-lasting protection compared to current options.

What evidence suggests that this trial's treatments could be effective for RSV?

Research has shown that the BLB-201 RSV vaccine yields promising results. In earlier studies, recipients of the BLB-201 vaccine were over 80% less likely to develop RSV symptoms. This suggests the vaccine could significantly reduce the risk of RSV illness. The vaccine also effectively triggers the body's immune response and is well tolerated, with no major safety concerns reported. In this trial, different groups of children will receive varying doses of BLB-201 or a placebo to further assess its effectiveness and safety. These findings position BLB-201 as a hopeful option for preventing RSV in children. ^{1 3 4 6 7}

Who Is on the Research Team?

Hong Jin, MD

Principal Investigator

Blue Lake Biotechnology Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

I am up to date with all vaccinations suitable for my age.

Exclusion 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.

Maternal history of positive HIV test before or during pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or two doses of BLB-201 or placebo by intranasal route

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BLB-201

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU Experimental Treatment 1 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 PFU Experimental Treatment 1 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 PFU Experimental Treatment 1 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 PFU Experimental Treatment 1 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 PFU Experimental Treatment 1 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-, Placebo Active Control 1 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-, Placebo Placebo Group 1 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-, Placebo Placebo Group 1 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+, Placebo Placebo Group 1 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+, Placebo Placebo Group 1 Intervention

4 RSV seropositive participants will be administered placebo by intranasal route on Day 1

Who Is Running the Clinical Trial?

Blue Lake Biotechnology Inc.

Lead Sponsor

Trials

2

Recruited

170+

Citations

1. bluelakebiotechnology.com bluelakebiotechnology.com/news/blue-lake-biotechnology-reports-positive-interim-clinical-data-innbspchildren-for-its-rsv-vaccine-candidatenbsp

Blue Lake Biotechnology reports positive interim clinical ... The data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05655182

A Study of BLB-201 RSV Vaccine in Infants and Children 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10599610/

Intranasal parainfluenza virus type 5 (PIV5)–vectored RSV ... Overall, the results suggested that BLB201 boosted RSV-specific serum Ab levels in young adults (33 to 59 years old) and elderly (61 to 75 ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/blue-lake-biotechnology-sees-success-in-early-rsv-vaccine-results/

Blue Lake Biotechnology sees success in early RSV ... Crucially research found that participants who received BLB201 had been more than 80% less likely to contract symptomatic RSV infections than ...

5. bluelakebiotechnology.com bluelakebiotechnology.com/news/blue-lake-reports-additional-data-from-blb201-rsv-ph1-2

Blue Lake Biotechnology Reports Additional Promising ... “The preliminary analysis showing a greater than 80% reduction in the risk of symptomatic RSV infection underscores the promise of BLB201 as a ...

6. bluelakebiotechnology.com bluelakebiotechnology.com/news/blue-lake-at-13th-international-rsv-symposium

Blue Lake Biotechnology to Present Safety and ... Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as ...

7. downloads.regulations.gov downloads.regulations.gov/FDA-2024-N-4732-0003/attachment_1.pdf

Blue Lake Biotechnology, Inc. BLB201, a live PIV5-based RSV vaccine expressing wild type RSV F and administered intranasally, is safe and efficacious in mice, cotton rats ...