Viral Infections in Healthy and Immunocompromised Hosts
Viral Infections in Healthy and Immunocompromised Hosts
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.
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.
-  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.

 3. Adults who are unable to provide initial consent may be enrolled providing
 procedures per Human Research Protections Program (HRPP) standard operation
 procedure (SOP) 14E have been followed.

 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 (OHRSPHRPP SOP 14D) 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