Volunteer Screening for Vaccine and Antivirals Clinical Trials

Normal Physiology Clinical Trial

Official title: Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies

Status Completed

Clinical Trial Summary

Background:

• Vaccines and antiviral therapies are critical for preventing and treating viral diseases. Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers are healthy and eligible to participate in these studies, they will be screened before the start of the study. This screening may involve a medical history, physical exam, and blood test. Other samples may also be collected. This study will help identify volunteers who are eligible to participate in vaccine or antiviral therapy trials.

Objectives:

• To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus infections.

Eligibility:

• Healthy volunteers at least 18 years of age.

Design:

• Screening may begin several months before the start of the clinical trial. Participants may come to the National Institutes of Health clinic one or more times.

• Participants may be screened with a physical exam and medical history. Blood samples will be collected. Other samples may also be collected, including urine, nasal wash, nasal swab, or stool samples. All samples will be stored for reference by the study researchers....

Clinical Trial Description

Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Testing of vaccines, antiviral medications, or live virus challenge studies in volunteers may requires knowing whether the subject has been previously infected by the virus. We will recruit healthy persons for this study and screen them for their eligibility to participate in clinical trials of investigational vaccines or antiviral products, investigational studies of licensed products, or live virus challenge studies. In most cases this will involve a medical history, physical examination, and obtaining blood to test for antibodies to the virus being studied in a vaccine or antiviral therapy trial or live virus challenge study. In some cases blood may be tested for viral DNA or RNA and urine, stool, saliva, nasal swab, or nasopharyngeal wash secretions may be tested for viruses or antibodies to the virus. Additional testing, such as an electrocardiogram (EKG), chest radiograph (CXR), and pulmonary function tests (PFTs) may be done. Samples will also be stored for future research. This study should help us to identify a group of volunteers that will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, or live virus challenge studies, .conducted by the Laboratory of Infectious Diseases, NIAID at the NIH Clinical Center. ;

Related Conditions & MeSH terms

• Normal Physiology

• NCT number: NCT01593709
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: November 27, 2012
• Completion date: July 21, 2021