Healthy volunteers needed for studies on Zika and influenza

Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

This study is looking for healthy volunteers to help researchers learn more about Zika and influenza by collecting samples and seeing how the body reacts to the flu virus.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT01386424 on ClinicalTrials.gov

What this trial studies

This study enrolls healthy volunteers to collect serum and RNA samples and gather clinical and laboratory data to determine eligibility for future clinical studies on infectious diseases like Zika and influenza. It includes influenza challenge studies, where participants are exposed to the flu virus to study the body's response and improve prevention and treatment methods. The goal is to enhance understanding of viral infections and assist in vaccine development. Up to 5000 participants will be recruited at the NIH Clinical Center.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with no significant health abnormalities.

Not a fit: Patients with significant health issues or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prevention and treatment strategies for influenza and other viral infections.

How similar studies have performed: Previous human challenge studies have provided valuable insights, but this approach is expanding to include emerging infectious diseases, making it a novel effort.

Eligibility criteria

* INCLUSION CRITERIA:

  1. Greater than or equal to 18 and less than or equal to 65 years old, and have no significant health abnormalities
  2. Willing to consider taking part in a future LID Clinical Studies Unit healthy volunteer study
  3. A female participant is eligible for this study if she is any of the following:
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
* Of childbearing potential but agrees to practice effective contraception or abstinence (from heterosexual sex) for 4 weeks prior to enrolling into a spceific study and during the study.

NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.

4\. Willing to have samples stored for future research

EXCLUSION CRITERIA:

1. Self-reported history of any significant medical condition including but not limited to:

   * Chronic pulmonary disease (such as asthma, emphysema)
   * Chronic cardiovascular disease (cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)
   * Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (diabetes mellitus, renal dysfunction, hemoglobinopathies)
   * Immunosuppression or cancer
   * Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)
   * Drug and/or alcohol dependency and/or abuse
2. Any condition that, in the judgment of the Principal Investigator, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Matthew J Memoli, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rani S Athota, Ph.D.

Conditions Zika; Influenza; Future; Flu; Observation; Vaccine; Healthy Volunteer; HV