Is NCT07111078 recruiting in Bethesda, MD?

Yes, NCT07111078 is currently recruiting participants at its Bethesda, MD location. This influenza prevention clinical trial is actively enrolling qualified participants.

How do I join the influenza prevention 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 Prevention Clinical Trial in Bethesda, MD

About This Influenza Prevention Study in Bethesda

Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a new flu vaccine with and without a new adjuvant. Eligibility: Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020. Design: Participants will have 12 clinic visits over 15 months. The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot. Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms. Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes. Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.

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

Who Can Participate

Inclusion Criteria

A participant must meet all of the following criteria:

Healthy adults between the ages of 18-50 years, inclusive

Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the

Exclusion Criteria

Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season

Able and willing to complete the informed consent process

The ability to read and comprehend English as all consent and recruitment materials are in English.

Available for clinic visits for 68 weeks after the first dose, including through the 2025-2026 influenza season

Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process

Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before enrollment

Agrees to not receive any licensed influenza vaccination during study participation due to potential confounding of study results

Willing to have blood and mucosal samples collected, stored indefinitely, and used for research purposes. Laboratory Criteria within 56 days before enrollment:

WBC and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee

Total lymphocyte count \>= 800 cells/microliter

Platelets = 125,000-400,000 cells/mircoliter

Hemoglobin within institutional normal range or accompanied by approval of the PI or designee

Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN

Alkaline phosphatase (ALP) \< 1.1 x institutional ULN

Total bilirubin within institutional normal range or accompanied by approval of the PI or designee

Serum creatinine \<= 1.1 x institutional ULN

Negative for HIV infection by an FDA-approved method of detection Criteria applicable to women of childbearing potential:

Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment

Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study EXCLUSION CRITERIA: Participant will be excluded if one or more of the following conditions apply: -Women who are breast-feeding or planning to become pregnant during the study A participant has received any of the following substances:

Receipt of any licensed influenza vaccine or lab-confirmed influenza infection within 6 months prior to enrollment.

Plan to or are required to receive the 2025-2026 or 2026-2027 licensed influenza vaccines

Live attenuated vaccines within 4 weeks prior to enrollment

Inactivated vaccines within 2 weeks prior to enrollment

mRNA vaccines within 4 weeks prior to enrollment

Receipt of the HA ferritin influenza vaccine VRC-FLUNPF081-00-VP alone or in prime-boost regimens with VRC-FLUDNA082-00-VP (HA-F A/Sing, DNA A/Sing, VRC 316).

Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)

Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)

More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment

Blood products within 16 weeks prior to enrollment

Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study

Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule

Current anti-TB prophylaxis or therapy Participant has a history of any of the following clinically significant conditions:

Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee

Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema

Asthma that is not well controlled

Diabetes mellitus (type I or II), except for gestational diabetes

Thyroid disease that is not well controlled

Idiopathic urticaria within the past year

Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies

Hypertension that is not well controlled

Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws

Malignancy that is active or history of malignancy that is likely to recur during the period of the study

Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years

Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen

Guillain-Barr(SqrRoot)(Copyright) Syndrome

Any medical, social condition, occupational reason, or other reason that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs a participant's ability to give informed consent, including but not limited to clinically significant forms of infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.

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 (NCT07111078) 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 Prevention Treatment Options in Bethesda, MD

If you're searching for influenza prevention treatment options in Bethesda, MD, this clinical trial (NCT07111078) 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 prevention 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 prevention clinical trials near you to find additional studies recruiting in your area.

Influenza Prevention Clinical Trial in Bethesda, MD

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