Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 30, 2011

Keywords

ClinConnect Summary

This clinical trial, run by the Laboratory of Infectious Diseases (LID), is looking for healthy volunteers to help study viruses like Zika and influenza (the flu). The goal is to better understand these infections and develop vaccines and treatments. If you're between the ages of 18 and 65 and in good health, you might be eligible to participate. The screening process involves a few tests, including a medical history check, blood and urine tests, an electrocardiogram (which measures your heart's rhythm), and a chest x-ray.

Participants can expect to spend about 3 to 5 hours at the screening appointment. Once enrolled, healthy volunteers may be part of studies for up to a year, but they can choose to leave at any time. It's important to know that if you are a woman of childbearing potential, you will need to agree to use effective birth control during the study. This trial is a great opportunity to contribute to important medical research while helping scientists learn more about diseases that affect many people.

Gender

ALL

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