Viral Infections in Healthy and Immunocompromised Hosts

• ClinicalTrials.gov Identifier: NCT01306084
• Recruitment Status: Recruiting
• First Posted: March 1, 2011
• Last Update Posted: May 23, 2023
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description

Brief 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.

Condition or disease
Anogenital Herpes; COVID-19; Herpes Labialis

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 weill review tissue biosies 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 FDA-approved 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

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Viral Infections in Healthy and Immunocompromised Hosts
• Actual Study Start Date: March 15, 2011

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

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... [ Time Frame: open-ended ]
   January 2031

Eligibility Criteria

• Ages Eligible for Study: 6 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: 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.

Criteria

• INCLUSION CRITERIA:

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

     i. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center

     ii. Patients who are < 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.

  2. Must have (or be suspected of having) a viral infection, that is of interest to LID investigators. Alternatively, must be 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 an FDA approved vaccine.
  3. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) Policy 403 have been followed.
  4. 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:

1. Patients who are unable to safely undergo study procedures and tests.

2. Patients unwilling to have samples collected and stored for future use.

   INCLUSION OF VULNERABLE PARTICIPANTS:

   -Children:

   Children younger than 2 years of age will be enrolled only remotely from non-NIH medical facilities and will not be seen at the Clinical Center, because children of this age are susceptible to viral infections, some of which are more likely to occur in this very young population or could be more severe. Title 45 of the United States Code of Federal Regulations (CFR) Part 46 Subpart D and HRPP Policy 402 will be followed to comply with research involving children. The proposed research poses a risk no greater than that encountered with blood tests or other minimally invasive tests ordered as part of a routine history and physical examination. The PI will ensure that appropriate permission from each child s parent(s) or guardian has been obtained for participation in this study.

   -Pregnant Women:

   Pregnant women are eligible to participate in this study as they are susceptible to viral infections, some of which may be more severe in this patient population. This study provides an opportunity to learn more about viral infections in pregnant women. This information may be meaningful in informing disease severity, clinical practice for treating pregnant women, or in leading to new treatments for this population. This information cannot be gained without the participation of pregnant women. The primary procedure performed under this protocol is a blood draw but other procedures may be performed and are considered minimal risk in clinical practice. No procedures that would affect a developing fetus or affect a baby through breastfeeding are performed in the protocol.

   -Decisionally Impaired Adults:

   Adults who are unable to provide initial informed consent are eligible to enroll. Also adults who lose the ability to provide on-going consent subsequent to giving initial consent may continue to participate. These adults are susceptible to viral infections and we can learn about viral infections that may occur in this population. Institutionalized adults will not be enrolled. The procedures utilized are clinically considered to be of minimal risk.

Contacts and Locations

Contacts

Contact: Jeffrey I Cohen, M.D.; (301) 496-5265; jcohen@niaid.nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center; Recruiting

Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Jeffrey I Cohen, M.D.; National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT01306084
• Other Study ID Numbers: 110109; 11-I-0109
• First Posted: March 1, 2011
• Last Update Posted: May 23, 2023
• Last Verified: May 18, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

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

Additional relevant MeSH terms:

Infections; Herpes Simplex; Virus Diseases; Herpes Labialis; Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Lip Diseases; Mouth Diseases; Stomatognathic Diseases