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Screening voor LID Clinical Studies Unit Protocollen voor gezonde vrijwilligers

2 november 2026 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

The high morbidity and mortality associated with both pandemic and seasonal influenza and the anticipation for future influenza pandemics puts influenza front and center in infectious disease research. Because the natural history and pathogenesis of human influenza has not been well characterized and cannot be adequately studied in animal models or with current in vitro techniques, important questions about influenza pathogenesis can only be approached through human challenge studies.

Previous human challenge studies have addressed some aspects of the natural history by evaluating the timing of viral replication, shedding, clinical symptoms, and innate and adaptive immune responses. Although these studies have provided important information, all but one was performed prior to 1990. Without exception, these studies had limitations due to the scope of the study and/or the scientific techniques available at that time.

While initially the protocol was designed to screen participants for influenza challenge studies, we have expanded our scope of research to include emerging and re-emerging infectious diseases.The primary goal of this study is to collect and store serum and RNA samples and obtain clinical and laboratory data from volunteers to determine in advance if they are potentially eligible to participate in future clinical studies. To accomplish this objective, up to 5000 participants will be enrolled in this protocol at the NIH Clinical Center clinic or day hospital in order to maintain a pool of participants who have been evaluated and can be screened for future LID Clinical Studies Unit protocols.

Studietype

Observationeel

Inschrijving (Geschat)

5000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Rani S Athota, Ph.D.
Telefoonnummer: (301) 594-0803
E-mail: rani.athota@nih.gov

Studie Contact Back-up

Naam: Matthew J Memoli, M.D.
Telefoonnummer: (301) 496-2433
E-mail: mm982v@nih.gov

Studie Locaties

Verenigde Staten
- Maryland
  - Bethesda, Maryland, Verenigde Staten, 20892
    - Werving
    - National Institutes of Health Clinical Center
    - Contact:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Telefoonnummer: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

General Population

Beschrijving

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:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: OTHER
Tijdsperspectieven: OTHER

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Healthy Volunteers Healthy Volunteers

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Find Healthy volunteers for research Tijdsspanne: One time for a participant, 20 year open study	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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Onderzoekers

Hoofdonderzoeker: Matthew J Memoli, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

<p>NIH Clinical Center Detailed Web Page</p>

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juli 2011

Studieregistratiedata

Eerst ingediend

30 juni 2011

Eerst ingediend dat voldeed aan de QC-criteria