Viral Infections in Healthy and Immunocompromised Hosts

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 9 December 2021
immunoglobulin
Accepts healthy volunteers

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.

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, 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 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.

Details
Condition EPSTEIN BARR VIRUS INFECTION, Herpes Labialis, Herpes Simplex, Cytomegalic Inclusion Disease, Adenovirus infection, Cold Sores (Herpes Labialis Infections), Cytomegalovirus (CMV) Retinitis, Chickenpox (Varicella Zoster Infection), Herpes Simplex Infections, Cytomegalovirus Infections, Varicella Zoster Virus Infection, *COVID-19, Covid-19, Respiratory Virus Infection, Herpes Viruses, Norovirus Infection, Human Herpes Virus 6 Infection, Anogenital Herpes, cold sores
Clinical Study IdentifierNCT01306084
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients who are unable to safely undergo study procedures and tests
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
involving children. The proposed research poses a risk no greater than that
Subpart D and HRPP Policy 402 will be followed to comply with research
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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