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Virus Therapy

CPI-RSV-F Vaccine (BLB-201) for Respiratory Syncytial Virus

Phase 1
Waitlist Available
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, and day 29
Awards & highlights

Study Summary

This trial is testing a new virus to see if it is safe and tolerated in adults of different ages. The virus is given as a single dose intranasally (through the nose).

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15, and day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15, and day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Solicited Adverse Events
Unsolicited Adverse Events
Secondary outcome measures
Serious Adverse Events through trial completion
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest
Serum IgG titers to RSV protein

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2, older adult cohort (age 60-75)Experimental Treatment1 Intervention
BLB-201 administered as a single dose of 10^7.5 PFU by intranasal route on Day 1
Group II: Group 1, young adult cohort (age 18-59)Experimental Treatment1 Intervention
BLB-201 administered as a single dose of 10^7.5 PFU by intranasal route on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-RSV-F Vaccine (BLB-201)
2022
Completed Phase 1
~30

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
137 Total Patients Enrolled
Paul Spearman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
532 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria is used to select personnel for this investigation?

"This clinical trial is seeking 30 human participants aged 18-75 with respiratory syncytial virus infections. Essential criteria for females of childbearing potential include having a negative pregnancy test within 24 hours prior to each vaccination, practicing true abstinence or employing an effective form of contraception if in a heterosexual relationship and agreeing not to donate eggs from the time of vaccination until 90 days after it ends. Male candidates must be postpubertal, use condoms during sexual activity with a female partner that are also utilizing primary contraception and refrain from sperm donation throughout the study timeline. All individuals must provide informed consent before participating in any procedures related to this trial; additionally they"

Answered by AI

Has the FDA sanctioned CPI-RSV-F Vaccine (BLB-201) for public use?

"As this is the initial phase of clinical trials, demonstrating limited data for both safety and efficacy, our team at Power deemed CPI-RSV-F Vaccine (BLB-201) to have a score of 1 out of 3."

Answered by AI

Does the research team have any age restrictions for participants in this investigation?

"The upper and lower age limit for this trial is 75 years old and 18 years respectively."

Answered by AI

Is this trial currently seeking participants?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially advertised on July 20th 2022 and most recently updated on August 16th 2022. 30 participants are sought from 2 different locations."

Answered by AI

What results is the clinical trial anticipated to yield?

"This clinical trial will assess Solicited Adverse Events (SAEs) over a 29-day span. The secondary objectives include evaluating Serious Adverse Events related to the vaccine, noting new onset chronic medical conditions and monitoring frequencies of special interest adverse events from first dose through completion of the trial which is expected to be roughly 6 months post dosing. Lastly, this study will measure changes in RSV F-specific IgG titers after receiving their initial dosage of CPI-RSV-F."

Answered by AI

What is the upper capacity for participants in this trial?

"Affirmatively, the information posted on clinicaltrials.gov verifies that this research is seeking participants with recruitment starting July 20th 2020 and the latest update occurring August 16th 2022. A total of 30 patients will be admitted at two different medical centres."

Answered by AI
~11 spots leftby Apr 2025