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Respiratory Syncytial Virus InfectionsPhase 1NCT05281263

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

A Phase 1 study testing CPI-RSV-F Vaccine (BLB-201) in people with Respiratory Syncytial Virus Infections, run by Blue Lake Biotechnology Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
CPI-RSV-F Vaccine (BLB-201)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
20 Jul 2022to 3 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 #4. 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
  • History of postinfectious or postvaccine neurological sequelae.
  • Autoimmune, inflammatory, vasculitic, or rheumatic disease or immunodeficiency disorder.
  • Any significant abnormality altering the anatomy of the nose.
  • History of significant/severe wheeze, respiratory symptoms resulting in hospitalization, or known bronchial hyperreactivity to viruses.
  • History of asthma or reactive airway disease as an adult, cystic fibrosis, bronchopulmonary dysplasia, or chronic obstructive pulmonary disease.
  • History of anaphylaxis or other severe allergic reaction, e.g., generalized urticaria, angioedema, or other significant reaction to any previous licensed or unlicensed vaccines. - Have a diagnosis of schizophrenia, bipolar disease, or other psychiatric disease that may interfere with subject compliance or safety evaluations.
  • Use or anticipated use during the conduct of the trial of high-dose inhaled corticosteroids from 30 days prior to 14 days after trial vaccination.
  • Receipt or anticipated receipt of, within 7 days prior to through 28 days after trial vaccination, any intranasal medication including FDA-approved prescription or over-the-counter products or non-FDA-approved alternative medicine products (e.g. Ayurvedic oil or other naturopathic substances).
  • Currently smoking or vaping, or history of regular smoking or vaping in the past two years.
  • Anticipated use of nasal irrigation (e.g. Neti Pot™) after enrollment through 28 days after trial vaccination.
  • Positive hepatitis C or HIV serology, or positive hepatitis B serology not attributable to hepatitis B immunization.
  • History of alcohol or drug abuse within 5 years prior to trial vaccination.
  • Received experimental agent within 30 days prior to trial vaccination or expects to receive experimental agent (not including vaccines made available under an FDA emergency use authorization) anytime during the 6-month trial period.
  • Female subjects that are breastfeeding or plan to breastfeed during the trial.
  • Subjects who reside in a nursing home.
  • Any condition that would in the opinion of the site investigator place the subject at unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
CPI-RSV-F Vaccine (BLB-201)
Keywords
Human respiratory syncytial virus (RSV), lower respiratory tract infection (LRTI)
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    see arm/group description

Study groups in NCT05281263
Study groupRoleWhat they receive
Group 1, young adult cohort (age 18-59)ExperimentalBLB-201 administered as a single dose of 10^7.5 PFU by intranasal route on Day 1
Receives: Biological: CPI-RSV-F Vaccine (BLB-201)
Group 2, older adult cohort (age 60-75)ExperimentalBLB-201 administered as a single dose of 10^7.5 PFU by intranasal route on Day 1
Receives: Biological: CPI-RSV-F Vaccine (BLB-201)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solicited Adverse Events

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

    Measured: Day 1-8

  2. Unsolicited Adverse Events

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

    Measured: Day 1-29

Secondary outcomes (3)

  1. Serum IgG titers to RSV protein

    Change in RSV specific IgG titers after the first dose of BLB-201.

    Measured: Day 15, and Day 29

  2. Serious Adverse Events through trial completion

    Frequencies of Serious Adverse Events (SAEs) categorized by vaccine relatedness from the first dose of BLB-201 through trial completion (approximately 6 months after dosing).

    Measured: Day 1-181

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

    Frequencies of Serious Adverse Events (SAEs) categorized by vaccine relatedness, new-onset chronic medical conditions (NOCMCs), and adverse events of special interest (MAAEs), from the first dose of BLB-201 through trial completion (approximately 6 months after dosing).

    Measured: Day 1-181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start20 Jul 2022
  3. Primary completion5 Dec 2022
  4. Study completion3 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281263
Sponsor's protocol ID
BLB-201-001
Status last verified
Dec 2023
First submitted
7 Mar 2022
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.

Publications

  • 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.

    PubMed 37878713

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPI-RSV-F Vaccine (BLB-201) in people with Respiratory Syncytial Virus Infections, run by Blue Lake Biotechnology Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited Adverse Events (time frame: Day 1-8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05281263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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