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New universal flu vaccine enters human testing

NCT ID NCT07215858

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 58 times

Summary

This study tests an experimental flu vaccine called BPL-1357, given as a shot or nasal spray, to see if it is safe and can protect against multiple flu types. About 129 healthy adults aged 18-55 will receive the vaccine or a placebo, then be exposed to a flu virus in a controlled setting. The goal is to find a vaccine that works against seasonal and pandemic flu strains.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BPL-1357 (a whole-virus flu vaccine given as a shot or nasal spray)
What this could lead to
If successful, this vaccine could provide broader protection against different flu strains, potentially helping to prevent future flu pandemics.
What could go wrong
This is an early phase 2 trial with only 129 participants, so results may not apply to everyone. The vaccine may not work as hoped, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 129 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: 1. Adults \>=18 and \<= 55 years of age at the time of consent. 2. Able to provide written informed consent. 3. 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). 4. 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). 5. 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). 6. Has not received any broadly protective influenza vaccine in the past. 7. Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63): 1. 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. 2. 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 8. Able to speak and understand English. 9. A negative HIV test within 6 months before enrollment. 10. 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's 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. 11. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63). 12. 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. 13. 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: 1. Current medical conditions (self-reported or medically documented) including but not limited to: 1. Chronic pulmonary disease (e.g., asthma, emphysema). 2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects). 3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies). 4. Immunosuppression, immune deficiency, or ongoing malignancy. 5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures). 2. Body mass index (BMI) \<18 and \>35. 3. Pregnant or breastfeeding. 4. History of postinfectious or postvaccine neurological sequelae including GBS. 5. History of stroke within the past 5 years. 6. Acute illness within 7 days prior to enrollment (PAD0). 7. Known allergy to influenza vaccination or components contained in the influenza vaccine being used. 8. Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications). 9. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides). 10. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment. 11. Receipt of any unlicensed drug or investigational agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment. 12. Receipt of any unlicensed vaccine within 6 months prior to enrollment. 13. 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. 14. 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. 15. History of angioedema or anaphylaxis. 16. Study site staff who directly report to the study or site PI are excluded from participation. 17. 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. 18. 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: 1. Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0). 2. Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0). 3. 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. 4. Pregnant or breastfeeding. 5. Positive test for influenza within 8 weeks prior to challenge.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Texas Medical Branch, Galveston

    NOT_YET_RECRUITING

    Galveston, Texas, 77555, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.