BPL-1357 Against H1N1 Influenza Virus Challenge

NCT07215858 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10002409002409-I
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital. ...

Conditions

Influenza; Human

Keywords

Influenza; Vaccine; Human Challenge

Outcome Measures

Primary Outcomes (2)

• Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs)

  Safety of the vaccine will be assessed, including standardized measurement of immediate reactogenicity by symptom survey, as well as long-term follow-up for any SAEs, including after challenge, will be performed.

  15-25 weeks

• Rate of mild-to-moderate influenza disease (MMID), defined as a positive US FDA-approved clinical test for influenza plus one or more influenza symptoms

  Rate of MMID will be compared across groups to estimate vaccine efficacy.

  7-17 weeks

Secondary Outcomes (4)

• Immunogenicity at 28 days after vaccine dose 2 (PAD56):

  8 weeks

• Mean duration (days) of shedding as measured by rtPCR.

  7-17 weeks

• Proportion of patients who shed virus after influenza challenge as measured by rtPCR.

  7-17 weeks

• Total FLU-PRO questionnaire scores after influenza challenge.

  7-17 weeks

Study Arms (3)

Group A

EXPERIMENTAL

BPL-1357 given intramuscularly. Placebo given intranasally.

Biological: BPL-1357 IM; Other: Placebo IN

Group B

EXPERIMENTAL

BPL-1357 given intranasally. Placebo given intramuscularly.

Biological: BPL-1357 IN; Other: Placebo IM

Group C

PLACEBO COMPARATOR

Placebo given intramuscularly and intranasally.

Other: Placebo IM; Other: Placebo IN

Interventions

BPL-1357 IM BIOLOGICAL

Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intramuscularly.

Group A

BPL-1357 IN BIOLOGICAL

Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intranasally.

Group B

Placebo IM OTHER

Placebo given intramuscularly.

Group B; Group C

Placebo IN OTHER

Placebo given intranasally.

Group A; Group C

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:
• Adults \>=18 and \<= 55 years of age at the time of consent.
• Able to provide written informed consent.
• Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).
• Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).
• Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).
• Has not received any broadly protective influenza vaccine in the past.
• Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63):
• Is infertile, including postmenopausal status (as defined by age .45 years plus no menses for \>= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.
• Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of contraception, and their male partner will use a condom with spermicide. Acceptable methods of female contraception include
• the following:
• Bilateral tubal ligation
• Implant of levonorgestrel
• Injectable progestogen
• Oral contraceptive pills

You may not qualify if:

• Individuals meeting any of the following criteria will be excluded from study participation:
• Current medical conditions (self-reported or medically documented) 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 (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression, immune deficiency, or ongoing malignancy.
• Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).
• Body mass index (BMI) \<18 and \>35.
• Pregnant or breastfeeding.
• History of postinfectious or postvaccine neurological sequelae including GBS.
• History of stroke within the past 5 years.
• Acute illness within 7 days prior to enrollment (PAD0).
• Known allergy to influenza vaccination or components contained in the influenza vaccine being used.
• Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications).
• Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).

Sponsors & Collaborators

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

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

NOT YET RECRUITING

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

Study Officials

• Luca T Giurgea, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca T Giurgea, M.D.

CONTACT

(301) 538-5235; luca.giurgea@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)