Anogenital HerpesNCT01306084
Viral Infections in Healthy and Immunocompromised Hosts
An observational study of Anogenital Herpes and COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Anogenital Herpes, COVID-19, Herpes Labialis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 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 6 months to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- The protocol is open to people of all ages;
- Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center.
- Patients who are less than 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.
- a. Persons having (or be suspected of having) a viral infection that is of interest to LID investigators.
- 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.
- Persons that may have had a recent viral infection that is of interest to LID investigators that has since cleared
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- 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 informed consent.
- Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) Policy 403 have been followed.
- Only subjects that are NIH employees or contractors who work at NIH will be enrolled in the COVID19 antibody cohort study on this protocol.
Who cannot join
- Patients who are unable to safely undergo study procedures and tests.
- Patients unwilling to have samples collected and stored for future use.
- 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
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
About this study
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.
Read more
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.
- Conditions
- Anogenital Herpes, COVID-19, Herpes Labialis
- Keywords
- SARS-CoV-2, Respiratory Infections, Norovirus, Adenovirus, Coronavirus, Natural History, Viral Infection, Respiratory Viruses
- Medical subject headings
- COVID-19, Herpes Labialis, Respiratory Tract Infections, Adenoviridae Infections, Coronavirus Infections, Virus Diseases
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: open-ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study start15 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anogenital HerpesStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey I Cohen, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306084
- Sponsor's protocol ID
- 110109
- Other IDs
- 11-I-0109
- Status last verified
- 10 Sep 2026
- First submitted
- 26 Feb 2011
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Infections in Healthy and Immunocompromised Hosts
- ClinicalTrials.gov ID
- NCT01306084
- Acronym / sponsor ID
- 110109
- Conditions
- Anogenital Herpes, COVID-19, Herpes Labialis
- Keywords
- SARS-CoV-2, Respiratory Infections, Norovirus, Adenovirus, Coronavirus, Natural History, Viral Infection, Respiratory Viruses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Mar 2011 (actual)
- First posted
- 1 Mar 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:
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 months to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
Key exclusion criteria (3 listed)
- Patients who are unable to safely undergo study procedures and tests.
- Patients unwilling to have samples collected and stored for future use.
- 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
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
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...
Time frame: open-ended
January 2031
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 26 Oct 2026.
- Derived from this study: PubMed 36482505Cohen 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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.
Jeffrey I Cohen, 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 Anogenital Herpes and COVID-19, 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 9 inclusion and 3 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 26 Oct 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 Jeffrey I Cohen, M.D. ((301) 496-5265, jcohen@niaid.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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... (time frame: open-ended). 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 NCT01306084, which also lists 1 linked publication.
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 26 Oct 2026.