Influenza study: BPL-1357 IM vs BPL-1357 IN
Official title BPL-1357 Against H1N1 Influenza Virus Challenge
ClinicalTrials.gov ID: NCT07215858
What this study is testing
What is BPL-1357 IM?
an investigational whole-virus influenza vaccine being studied as a potential flu prevention treatment is designed to stimulate the immune system to recognize and fight the four avian influenza viruses included in the vaccine
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if an experimental flu vaccine works and is safe. It also tests if the vaccine works better as a nasal spray or a shot.
- Who it's for
- Healthy men and women aged 18 to 55.
- What's involved
- Participants get a vaccine or a fake shot (placebo) in the arm or nose. Later, they stay in the hospital to be exposed to the flu virus and have blood and nasal tests.
- Time commitment
- The study lasts 5 to 8 months and includes 5 clinic visits plus a hospital stay of at least 9 days.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type...
- 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...
You likely can't join if
- 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...
- Immunosuppression, immune deficiency, or ongoing malignancy.
- Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).
- Body mass index (BMI) \ 35.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
- 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...
- 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...
- Participant is willing and able to comply with all trial procedures.
- 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) \ 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.