Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults

NCT05281263 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BLB-201-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase 1 trial is an open-label trial to evaluate the safety, tolerability and immunogenicity of a single dose (10\^7.5 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered as a single dose in 15 healthy young adults ages 18-59 years, and 15 older adults ages 60-75 years.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Human respiratory syncytial virus (RSV); lower respiratory tract infection (LRTI)

Outcome Measures

Primary Outcomes (2)

• Solicited Adverse Events

  Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing.

  Day 1-8

• Unsolicited Adverse Events

  Frequencies and grades of unsolicited AEs during a 28-day period after dosing.

  Day 1-29

Secondary Outcomes (3)

• Serum IgG titers to RSV protein

  Day 15, and Day 29

• Serious Adverse Events through trial completion

  Day 1-181

• Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest

  Day 1-181

Study Arms (2)

Group 1, young adult cohort (age 18-59)

EXPERIMENTAL

BLB-201 administered as a single dose of 10\^7.5 PFU by intranasal route on Day 1

Biological: CPI-RSV-F Vaccine (BLB-201)

Group 2, older adult cohort (age 60-75)

EXPERIMENTAL

BLB-201 administered as a single dose of 10\^7.5 PFU by intranasal route on Day 1

Biological: CPI-RSV-F Vaccine (BLB-201)

Interventions

CPI-RSV-F Vaccine (BLB-201) BIOLOGICAL

see arm/group description

Group 1, young adult cohort (age 18-59); Group 2, older adult cohort (age 60-75)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent prior to initiation of any trial procedures.
• Be able to understand and agrees to comply with planned trial procedures and be available for all trial visits and phone calls.
• Healthy male or non-pregnant female, between 18 and 59 years of age (Group 1) or between60 and 75 years of age (Group 2), inclusive, at time of trial vaccination.
• Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception. Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
• Male subjects agree to refrain from sperm donation from the time of vaccination until 90 days after vaccination.
• Female subjects agree to refrain from egg donation from time of vaccination until 90 days after vaccination.
• In good health.

You may not qualify if:

• History of clinically-significant or major disease that may interfere with a subject completing the trial and necessary investigations.
• Have an acute illness as determined by the site PI or sub-investigator within 72 hours prior to trial vaccination.
• Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination.
• Receipt of any live vaccine within the 30 days prior to trial vaccination.
• Receipt of any inactivated vaccine within the 14 days prior to trial vaccination.
• Receipt of any investigational vaccine within 12 months prior to trial vaccination (not including vaccines made available under an FDA emergency-use authorization).
• Any prior receipt of any investigational RSV vaccine or any PIV5-based vaccine (e.g. CVXGA1).
• Intention to receive any other vaccination before the last in person scheduled visit of the trial.
• Receipt or anticipated receipt of immunoglobulin or blood products within 90 days prior to trial vaccination through trial period.
• Loss (including blood donations) of 470 mL or more of blood within 90 days prior to trial vaccination.
• Receipt or anticipated receipt of systemic glucocorticoids within 30 days prior to trial vaccination through trial period.
• Receipt or anticipated receipt of any antiviral drug within 7 days prior to vaccination through 14 days after trial vaccination.
• History and/or symptoms indicative of upper or lower respiratory tract infection within 14 days prior to initial trial vaccination (e.g. cough, sore throat, body temperature of 99.5°F or greater, nasal congestion, dyspnea, tachypnea, wheezing, fatigue, myalgia).
• Any clinically significant history of heavy nosebleeds.
• History of chronic sinus infection.

Sponsors & Collaborators

• Blue Lake Biotechnology Inc.: lead

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Related Publications (1)

• Spearman P, Jin H, Knopp K, Xiao P, Gingerich MC, Kidd J, Singh K, Tellier M, Radziewicz H, Wu S, McGregor M, Freda B, Wang Z, John SP, Villinger FJ, He B. Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study. Sci Adv. 2023 Oct 27;9(43):eadj7611. doi: 10.1126/sciadv.adj7611. Epub 2023 Oct 25.

  PMID: 37878713 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Paul Spearman, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: July 20, 2022
• Primary Completion: December 5, 2022
• Study Completion: May 3, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

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 CyanVac authors of the publication(s).

Locations

US (2)