ZikaNCT01386424
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
An observational study of Zika and Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2011to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General Population
Who may be able to join
- 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.
- 4. Willing to have samples stored for future research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Future, Influenza, Flu, Observation, Vaccine, Healthy Volunteer, HV
- Medical subject headings
- Zika Virus Infection, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One time for a participant, 20 year open study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start20 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ZikaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386424
- Sponsor's protocol ID
- 110183
- Other IDs
- 11-I-0183
- Status last verified
- 13 Feb 2026
- First submitted
- 30 Jun 2011
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18230677Brown 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.
PubMed 4031039
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
- ClinicalTrials.gov ID
- NCT01386424
- Acronym / sponsor ID
- 110183
- Keywords
- Future, Influenza, Flu, Observation, Vaccine, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Jul 2011 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General Population
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Self-reported history of any significant medical condition including but not limited to:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Find Healthy volunteers for research
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 18230677Carrat 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.
- Background: PubMed 4031039Brown 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika and Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rani S Athota, Ph.D. ((301) 594-0803, rani.athota@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find Healthy volunteers for research (time frame: One time for a participant, 20 year open study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.