Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

NOT_YET_RECRUITING

BPL-1357 Against H1N1 Influenza Virus Challenge

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Influenza

Human

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

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 seaso...

Detailed Description

Study Description: This is a randomized, double-blinded, placebo-controlled, multicenter, phase 2 clinical trial of beta-propiolactone (BPL)-inactivated quadruple influenza virus cocktail vaccine (BP...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • 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 8 weeks (about 2 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
  • Diaphragm with spermicide
  • Intrauterine device (IUD)
  • Sexual abstinence
  • Vasectomized partner
  • Able to speak and understand English (NIH).
  • Able to speak and understand English and/or Spanish (UTMB).
  • A negative HIV test within 6 months before enrollment.
  • Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used 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 fs Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.
  • Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).
  • Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.
  • Participant is willing and able to comply with all trial procedures.
  • EXCLUSION CRITERIA
  • 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).
  • Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
  • Receipt of any unlicensed drug or investigational agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment.
  • Receipt of any unlicensed vaccine within 6 months prior to enrollment.
  • Self-reported or known history of alcoholism or drug abuse or use within 6 months prior to enrollment, or positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to vaccination on PAD0.
  • Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.
  • History of angioedema or anaphylaxis.
  • Study site staff who directly report to the study or site PI are excluded from participation.
  • Any condition, event or lab value that, in the judgment of the investigator, is a contraindication to protocol participation or would place the participant at increased risk for participation.
  • Any condition or event that, in the judgment of the investigator, impairs the participant's ability to give informed consent.
  • Individuals meeting any of the following criteria will be excluded from participation in Phase B:
  • Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0).
  • Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0).
  • Grade 3 or greater sign, symptom, or lab abnormality that is clinically significant and (in the opinion of the site PI) puts the participant at higher risk of adverse effects with influenza challenge.
  • Pregnant or breastfeeding.
  • Positive test for influenza within 8 weeks prior to challenge.

Exclusion

    Key Trial Info

    Start Date :

    March 2 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2028

    Estimated Enrollment :

    126 Patients enrolled

    Trial Details

    Trial ID

    NCT07215858

    Start Date

    March 2 2026

    End Date

    March 1 2028

    Last Update

    October 28 2025

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892

    2

    University of Texas Medical Branch, Galveston

    Galveston, Texas, United States, 77555