Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

NCT05027932 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 10000320000320-I
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community, the vaccine is not as effective. Researchers want to make flu vaccines that protect against changing flu strains. Objective: To test if a new flu vaccine is safe and if it creates an immune response. Eligibility: Healthy adults ages 18-55 who do not smoke and have not received a flu vaccine in the 8 weeks prior or a COVID-19 vaccine in the 4 weeks prior to enrollment. Design: Participants will be screened on a separate protocol. Participants will have 9 visits over 7 months. They will get a combination of study vaccine and/or placebo, both as a shot in the arm and as a spray into the nose, at 2 visits. For 7 days after getting the vaccines, they will take their temperature and complete online surveys at home to record any symptoms. At each visit, participants will have a physical exam and medical history. They will give blood and urine samples. They will have nasal testing. For this, a thin absorptive strip will be inserted into their nostril for 1 minute to collect mucus. At some visits, the inside of their nose will be wiped with a small brush to collect cells. For this, their nostril will be numbed to make it more comfortable. Some blood and nasal samples will be used for genetic testing. Participants who get flu-like symptoms during the study will be asked to collect nasal samples at home and send these samples back to NIH to test if they actually have the flu.

Conditions

Influenza

Keywords

Flu; Immunity; Virology; Investigational; Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Safety - Serious Adverse Event

  Type of SAEs through day V2D28.

  V2D28 (Day 56)

• Safety - Adverse Events

  Type and severity (by grading) of intervention-related AEs through day V2D28.

  V2D28 (Day 56)

Secondary Outcomes (4)

• Safety - Serious Adverse Event

  V2D182 (Day 210)

• Safety - Adverse Events

  V2D182 (Day 210)

• Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin

  V2D28 (Day 56)

• Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase

  V2D28 (Day 56)

Study Arms (3)

Group A

EXPERIMENTAL

15 participants receiving IM BPL1357 \& IN Placebo

Other: IN Placebo; Drug: BPL-1357

Group B

EXPERIMENTAL

15 participants receiving IN BPL1357 \& IM Placebo

Other: IM Placebo; Drug: BPL-1357

Group C

SHAM COMPARATOR

15 participants receiving IM and IN placebo

Other: IN Placebo; Other: IM Placebo

Interventions

IN Placebo OTHER

The placebo is normal saline in two syringes administered IN.

Group A; Group C

IM Placebo OTHER

The placebo is normal saline in a syringe administered IM.

Group B; Group C

BPL-1357 DRUG

BPL-1357 contains 4 whole inactivated avian influenza viruses: A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9. It is administered either IM or IN depending on the assigned treatment group.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals must meet all of the following criteria to be eligible for study participation:
• and \<= 55 years of age.
• Non-smoker (tobacco and cannabis) and does not use vape or e-cigarette products.
• Has not received influenza vaccination of any type in the 8 weeks prior to enrollment and willing to not receive influenza vaccination of any type until after the V2D56 visit. Participants who enroll in our study will be informed of the Centers for Disease Control and Prevention (CDC) recommendation to receive seasonal influenza vaccination annually.
• Has not received Coronavirus Disease 19 (COVID-19) vaccination of any type in the 4 weeks prior to enrollment and willing to not receive COVID-19 vaccination of any type until after the V2D28 visit. Participants who enroll in our study who are interested in getting a COVID-19 vaccination will be counselled to receive it prior to enrolling into our study.
• A female participant is eligible for this study if she is not pregnant or breastfeeding and meets one of the following criteria, beginning at least 4 weeks prior to enrollment through the end of the study period (V2D182):
• Is infertile, including postmenopausal status (as defined by no menses for \>= 1 year) or history of hysterectomy or bilateral oophorectomy.
• Agrees to practice abstinence.
• Agrees that, with heterosexual intercourse with a fertile male partner, she will use an acceptable form of contraception and her male partner will use a condom with spermicide. Acceptable effective methods of female contraception include the following: bilateral tubal ligation, implant of levonorgestrel, injectable progestogen, intrauterine device, oral contraceptive pills, and diaphragm with spermicide.
• Able to provide informed consent.
• Able to speak English.
• Human immunodeficiency virus (HIV) uninfected with a negative test within 60 days of enrollment.
• Does not use IN medications (including but not limited to nasal sprays, sinus rinses), over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John s Wort) within 14 days prior to study enrollment, and agrees not to use these mediations through the final study visit, unless approved by the investigator.
• Agrees not to donate blood or blood products from 3 months prior to enrollment through the final study visit.

You may not qualify if:

• Individuals meeting any of the following criteria will be excluded from study participation:
• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression, immune deficiency, or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., Bell s palsy, cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae including GBS.
• Body mass index (BMI) \<= 18 and \>= 35.
• Acute illness within 7 days prior to enrollment.
• Individuals who have grade 2 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
• Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.
• Known allergy to lidocaine or phenylephrine.
• Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Luca Giurgea
• Organization: Clinical Studies Unit, Laboratory of Infectious Diseases, NIAID, NIH

Luca.giurgea@nih.gov

301-538-5235

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2021
• First Posted: August 31, 2021
• Study Start: June 27, 2022
• Primary Completion: June 13, 2023
• Study Completion: February 25, 2025
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)