Is NCT07215858 recruiting in Bethesda, MD?

Yes, NCT07215858 is currently recruiting participants at its Bethesda, MD location. This influenza clinical trial is actively enrolling qualified participants.

How do I join the influenza clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Influenza Clinical Trial in Bethesda, MD

About This Influenza Study in Bethesda

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. ...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

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 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

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'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.

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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT07215858) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Influenza Treatment Options in Bethesda, MD

If you're searching for influenza treatment options in Bethesda, MD, this clinical trial (NCT07215858) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced influenza specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all influenza clinical trials near you to find additional studies recruiting in your area.

Influenza Clinical Trial in Bethesda, MD

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