Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

NCT01386424 | Recruiting

• 2 other identifiers: 11018311-I-0183
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zika; Influenza

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Find Healthy volunteers for research

  The primary goal of this study is to collect and store serum and RNAsamples and obtain clinical and laboratory data from volunteers todetermine in advance if they are potentially eligible to participate infuture LID Clincal Studies Unit protocols.

  One time for a participant, 20 year open study

Study Arms (1)

Healthy Volunteers

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Population

You may qualify if:

• Greater than or equal to 18 and less than or equal to 65 years old, and have no significant health abnormalities
• Willing to consider taking part in a future LID Clinical Studies Unit healthy volunteer study
• 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.
• \. Willing to have samples stored for future research

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

• Carrat F, Vergu E, Ferguson NM, Lemaitre M, Cauchemez S, Leach S, Valleron AJ. Time lines of infection and disease in human influenza: a review of volunteer challenge studies. Am J Epidemiol. 2008 Apr 1;167(7):775-85. doi: 10.1093/aje/kwm375. Epub 2008 Jan 29.

  PMID: 18230677 BACKGROUND

• Brown TA, Murphy BR, Radl J, Haaijman JJ, Mestecky J. Subclass distribution and molecular form of immunoglobulin A hemagglutinin antibodies in sera and nasal secretions after experimental secondary infection with influenza A virus in humans. J Clin Microbiol. 1985 Aug;22(2):259-64. doi: 10.1128/jcm.22.2.259-264.1985.

  PMID: 4031039 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Zika Virus Infection; Influenza, Human

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani S Athota, Ph.D.

CONTACT

(301) 594-0803; rani.athota@nih.gov

Matthew J Memoli, M.D.

CONTACT

(301) 496-2433; mm982v@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: July 20, 2011
• Last Updated: April 24, 2026

Record last verified: 2026-02-13

Locations

US (1)