Volunteer Screening for Vaccine and Antivirals Clinical Trials

NCT01593709 | Completed

• 2 other identifiers: 12012112-I-0121
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Normal Physiology

Keywords

Anti-infective agents; ANTI-VIRAL AGENTS; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To screen subjects for their eligibility to participate in clinical trials of investigational or licensed vaccines, antiviral products, or live virus challenge studies being evaluated for research purposes.

  Eligibility will be determined.

  At every patient contact.

Study Arms (1)

Cohort 1

Healthy adults; age 18 or older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers aged 18 or older.

You may qualify if:

• Age: 18 years of age or older
• Available to participate for the planned duration of the clinical trial for which the screening is being done
• Able and willing to complete the informed consent process
• Agree to participate in proceduresas needed for the clinical trial screening process.

You may not qualify if:

• A known condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
• Known to be pregnant or breast-feeding, or planning to become pregnant in the near future
• Use of a medication that significantly alters the immune system within the past 6 months or anticipated within the next year (e.g. immunoglobulin, systemic corticosteroids \> prednisone equivalent of 10 mg/kg/day)
• Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
• Abuse of illicit drugs, alcohol abuse, or alcohol dependency within the last 6 months
• Known to be infected with HIV or Hepatitis B and/or C.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Jeffrey I Cohen, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2012
• First Posted: May 8, 2012
• Study Start: November 27, 2012
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

US (1)