Healthy Volunteers Needed for Influenza and Zika Research
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Recruiting
Observational Study
ZikaInfluenza
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for healthy volunteers aged 18 to 65 to participate in research studies on influenza and Zika virus. Participants may experience mild exposure to the flu virus to help develop better treatments and vaccines.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old
I am in good health
I am willing to take part in future studies
I will use effective contraception if I am a woman of childbearing potential
I agree to have samples stored for future research
You may not be able to join if
I have a significant medical condition
I have a chronic lung disease, like asthma
I have a heart condition or have had heart surgery
I have diabetes or kidney problems
I have cancer or a weakened immune system
I have had a stroke or seizures
I have a history of drug or alcohol abuse
I cannot provide informed consent
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Background:
* The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases.
* Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infe…
Background:
* The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases.
* Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infections and assist in the development of vaccines and treatments for the infections. These clinical studies include influenza "challenge studies" as well as natural history studies and phase I trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus.
* In influenza challenge studies studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu and may also improve treatments for the flu.
* Natural history studies and phase I trials of new vaccines are performed so the researchers can learn how some viral infections occur and if new vaccines are safe and potentially effective in preventing the infections. In some of these studies, participants experience insect bites with special clean (non-infected) insects (such as mosquitos) to better understand the role of insects in these infections.
Objectives:
\- To screen healthy volunteers for future CSU studies.
Eligibility:
\- Healthy people between the ages of 18 and 65
Design:
* The 3- to 5-hour screening exam includes the following:
* Medical history and physical exam
* Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests
* Standard urine drug testing
* Electrocardiogram (ECG) to test heart rhythm and function
* Chest x-ray
* Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a CSU study or are found to be ineligible to participate.
* Volunteers may withdraw from the study pool at any time.
Trial Locations
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Status
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 …
* 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
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