ClinicalTrials.gg
RecruitingNCT01306084Updated Oct 29, 2026

Viral Infections in Healthy and Immunocompromised Hosts

An observational study in Anogenital Herpes, COVID-19 and Herpes Labialis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 6 Months to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

From the registry’s dates

  • Started Mar 2011; still recruiting 15 years 7 months later.
Updated Oct 26, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
6 Months to 120 Years
Sex
All
01

Study summary

Background:

- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development.

Objectives:

- To collect samples and data from individuals who have been exposed to or have contracted viral infections.

Eligibility:

  • Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases.
  • Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate.

Design:

  • Participants will be pre-screened to determine if they meet the eligibility criteria for the trial.
  • If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies.
  • Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing.
  • Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection.
  • Treatment is not offered under this study.
Read the detailed description

Viral infections are an important cause of morbidity and mortality in hospitalized patients as well as out-patients. New strains of viruses may appear and cause epidemics in healthy persons or immunocompromised persons. A better understanding of these new virus strains may help to control and prevent these infections. Some viral infections that would otherwise be asymptomatic or cause mild disease can be life threatening in immunocompromised persons.

Immunocompromised persons often shed high titers of virus for prolonged periods of time. In the absence of a potent immune system, viruses may evolve more rapidly in their hosts.

Therefore, analysis of sequential virus specimens from these patients can provide information on virus evolution, including how resistance to antiviral agents can develop. In addition, higher titers of virus may be associated with virus mutants that are more adapted to grow in cell culture. In this protocol we will obtain specimens containing viruses from otherwise healthy or immunocompromised patients over sequential periods of time to study their nucleic acid sequences, sensitivity to antiviral agents, cell types infected by the virus, and ability to grow in cell culture. In some cases, we will review tissue biopsies or clinical reports from outside laboratories to assist with the diagnosis of virus-associated diseases. We will also record the patient s signs and symptoms, take a short history or ask patients to fill out a questionnaire, note results of any pertinent laboratory work-up, and in some cases, obtain blood to measure immune responses, isolate antibodies or virus-specific T cells, or to look for viremia. This study will include patients with viral infections and/or receiving viral vaccines. This study should provide further understanding on how viruses evolve in their natural hosts, how they become resistant to antiviral agents, how antibody responses evolve to viruses, and might allow some currently uncultivatable viruses to be grown in cell culture.

02

Conditions studied

  • Anogenital Herpes
  • COVID-19
  • Herpes Labialis

Keywords

  • SARS-CoV-2
  • Respiratory Infections
  • Norovirus
  • Adenovirus
  • Coronavirus
  • Natural History
  • Viral Infection
  • Respiratory Viruses
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
6 Months to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy or immunocompromised subjects with viral infections, or suspected of having a viral infection, or recovering from a viral infection, or a close contact of someone who has had or is suspected to have had an acute or chronic viral infection. Subjects may either be at the Clinical Center or samples may be sent to LID directly from subjects enrolled at non-NIH sites.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The protocol is open to people of all ages;

    1. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center.
    2. Patients who are less than 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.
    1. a. Persons having (or be suspected of having) a viral infection that is of interest to LID investigators.

      b. Persons that are a close contact of someone who has (or is suspected of having) a viral infection that is of interest to LID investigators or is about to receive or have recently received a viral vaccine.

      c. Persons that may have had a recent viral infection that is of interest to LID investigators that has since cleared

      d. Healthy persons who will serve as controls for (a), (b), or (c) above. These persons will be 18 years of age or older and able to provide .

    2. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) Policy 403 have been followed.
    3. Only subjects that are NIH employees or contractors who work at NIH will be enrolled in the COVID19 antibody cohort study on this protocol.

Exclusion criteria

EXCLUSION CRITERIA

  1. Patients who are unable to safely undergo study procedures and tests.
  2. Patients unwilling to have samples collected and stored for future use.
  3. For the healthy controls cohort: persons who are \<18 years old, adults who lack decision-making capacity to consent to research participation, and pregnant women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 1

    NIH campus employees who have recently recovered from COVID-19

  • 2

    Clinical Center health care workers and ancillary staff who have close patient contact and possible exposures to SARS-CoV-2

  • 3

    Healthy and immunocompromised subjects who have or are suspected to have a viral infection

  • 4

    Healthy and immunocompromised subjects exposed to someone who has a viral infection or is suspected of having a viral infection

  • 5

    Healthy subjects who grew up in dengue endemic areas.

  • 6

    Healthy subjects with a history of viral hepatitis

06

What researchers measure

Primary outcomes

  1. Sample collection, analysis of immune function, or review of tissue biopsies or clinical reports from outside laboratories in designated populations with viral infections, suspected of having a viral infection, recovered from a viral infection o...

    January 2031

    Time frame: open-ended

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Publications

  • Cohen JI, Dropulic L, Wang K, Gangler K, Morgan K, Liepshutz K, Krogmann T, Ali MA, Qin J, Wang J, Vogel JS, Lei Y, Suzuki-Williams LP, Spalding C, Palmore TN, Burbelo PD. Comparison of Levels of Nasal, Salivary, and Plasma Antibody to Severe Acute Respiratory Syndrome Coronavirus 2 During Natural Infection and After Vaccination. Clin Infect Dis. 2023 Apr 17;76(8):1391-1399. doi: 10.1093/cid/ciac934. PubMed 36482505 ↗
09

Timeline

3 registry updates since Sep 25, 2026

Started Mar 2011 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2011
First posted
Mar 1, 2011
StartActual
Mar 15, 2011
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedFor the healthy controls cohort: persons who are <18 years old, decisionally impaired adultsadults who lack decision-making capacity to consent to research participation, and pregnant women
Oct 26, 2026
Show all 3 updates
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 27, 2026
    Minor edits only
    + 1 other change: verification date
  3. Oct 26, 2026
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedFor the healthy controls cohort: persons who are <18 years old, decisionally impaired adultsadults who lack decision-making capacity to consent to research participation, and pregnant women

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01306084
Responsible party
Sponsor
First posted
Mar 1, 2011
Start date
Mar 15, 2011
Last update
Oct 29, 2026

Study contacts

Jeffrey I Cohen, M.D.
Contact
jcohen@niaid.nih.gov
(301) 496-5265
Jeffrey I Cohen, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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