Evaluation of immune responses in adults after vaccination or infection
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
This study is testing how well the immune system responds in adults after they get vaccinated or recover from an infection to help improve future vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01132859 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate immune responses in adults aged 18 and older by collecting blood and tissue samples from individuals who have recently been vaccinated or recovered from infections. Participants will undergo clinical evaluations and provide various specimens, including blood and mucosal samples, to help researchers understand the immune correlates of protection. The data collected will enhance knowledge about immune responses and assist in the development of vaccines against infectious diseases. Participation is voluntary, and all procedures are optional.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 years and older who are willing to donate specimens for research purposes.
Not a fit: Patients with medical conditions that impair their ability to provide informed consent or those with bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccine development and better understanding of immune responses to infections.
How similar studies have performed: Other studies have shown success in evaluating immune responses through similar specimen collection methods, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 1. 18 years of age or older. 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 3. Able and willing to complete the informed consent process. 4. Willing to donate specimens for storage to be used for research. EXCLUSION CRITERIA: 1. Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant s ability to give informed consent. 2. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), use of anticoagulant medications for an ongoing medical condition, significant bruising or bleeding difficulties with intramuscular injections or blood draws. \[Note: Participants taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.\]
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Lesia K Dropulic, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: OPS Team, VRC
- Email: vrcops@nih.gov
- Phone: Not Listed
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.