NCT01306084

Viral Infections in Healthy and Immunocompromised Hosts

Recruiting now Last updated 13 March 2026

What this trial tests

trial in Anogenital Herpes in 1,000 participants. Currently enrolling.

Timeline

15 March 2011

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	15 March 2011
Sites	1 location across United States

Conditions studied

• Anogenital Herpes — all drugs for Anogenital Herpes →
• COVID-19 — all drugs for COVID-19 →
• Herpes Labialis — all drugs for Herpes Labialis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 6 Months to 120, any sex, with Anogenital Herpes or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Static and Evolving Norovirus Genotypes: Implications for Epidemiology and Immunity.
   Parra GI, Squires RB, Karangwa CK, Johnson JA, et al · · 2017 · cited 219× · PMID 28103318 · DOI 10.1371/journal.ppat.1006136
2. Genome of Emerging Norovirus GII.17, United States, 2014.
   Parra GI, Green KY. · · 2015 · cited 90× · PMID 26196235 · DOI 10.3201/eid2108.150652
3. Sequential gastroenteritis episodes caused by 2 norovirus genotypes.
   Parra GI, Green KY. · · 2014 · cited 39× · PMID 24857806 · DOI 10.3201/eid2006.131627
4. Comparison of Levels of Nasal, Salivary, and Plasma Antibody to Severe Acute Respiratory Syndrome Coronavirus 2 During Natural Infection and After Vaccination.
   Cohen JI, Dropulic L, Wang K, Gangler K, et al · · 2023 · cited 22× · PMID 36482505 · DOI 10.1093/cid/ciac934
5. Reconstitution of Norovirus-Specific T-Cell Responses Following Hematopoietic Stem Cell Transplantation in Patients With Inborn Errors of Immunity and Chronic Norovirus Infection.
   Durkee-Shock J, Cohen A, Maghzian N, Pezzella G, et al · · 2025 · cited 5× · PMID 39140311 · DOI 10.1093/infdis/jiae398
6. High transmission of endemic human coronaviruses before and during the COVID-19 pandemic in adolescents in Cebu, Philippines.
   Joseph JO, Ylade M, Daag JV, Aogo R, et al · · 2024 · cited 2× · PMID 39333882 · DOI 10.1186/s12879-024-09672-8