A Phase 1 Trial of the Safety, Tolerability, and Immunogenicity of BLB-201 Vaccine in Healthy Young Adults and Older Adults

Blue Lake Biotechnology Inc.2 sites in 1 country30 target enrollmentJuly 20, 2022

ConditionsRespiratory Syncytial Virus Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Blue Lake Biotechnology Inc.
Enrollment: 30
Locations: 2
Primary Endpoint: Unsolicited Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This will be an open-label, age-escalation phase 1 trial of the PIV5 virus-vectored BLB-201 vaccine in healthy adults (males and nonpregnant females) 18 to 59 years of age (Group 1), and 60 to 75 years of age (Group 2). The trial is designed to assess the safety, tolerability, and immunogenicity of a single dose of intranasal BLB-201 at 10\^7.5 plaque- forming units (PFU) in both Group 1 and Group 2. The first 4 subjects in each group will be enrolled as sentinels and vaccination will proceed in a staged fashion.

Registry

clinicaltrials.gov

Start Date

July 20, 2022

End Date

May 3, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Blue Lake Biotechnology Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 of childbearing potential\* must use condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination. Such female partners must also use an acceptable form of primary contraception as described under inclusion criterion #
•If barrier methods are to be used, then double barrier methods of protection are required, i.e. male condom, in combination with a cap, diaphragm, or sponge with spermicide. \*Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Unsolicited Adverse Events

Time Frame: Day 1-29

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

Solicited Adverse Events

Time Frame: Day 1-8

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

Secondary Outcomes

Serious Adverse Events through trial completion(Day 1-181)
Serum IgG titers to RSV protein(Day 15, and Day 29)
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest(Day 1-181)