Understanding immune responses to COVID-19 vaccines
Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
This study is testing how healthy adults' immune systems react to COVID-19 vaccines and booster shots by looking at their blood samples before and after vaccination.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05078905 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how the immune system responds to vaccines against SARS-CoV-2 and other emerging infectious diseases. Healthy adults aged 18 and older, who are scheduled to receive a new vaccine or a booster shot, will participate by providing blood samples before and after vaccination. The study will involve up to eight visits over one year, during which participants will undergo health assessments and genetic testing. The primary goal is to characterize the immune responses to both primary and booster vaccinations and evaluate factors influencing the longevity of these responses.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 or older who are scheduled to receive a COVID-19 vaccine or booster.
Not a fit: Patients who have previously received a dose of the vaccine for the infectious disease being studied may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vaccine efficacy and inform future vaccination strategies.
How similar studies have performed: Other studies have shown success in characterizing immune responses to vaccines, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: General Inclusion Criteria for All Groups: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Age 18 years or older 3. Hemoglobin \>= 9.0 grams per deciliter (g/dL) or \>= 11.2 for women who are pregnant. 4. Willingness to give consent for the storage of blood samples for research 5. Ability of subject to understand and the willingness to sign a written informed consent document Inclusion Criteria for Primary (New) Vaccination Group: 1\. No history of having received a dose of the vaccine for the infectious disease being studied. Subjects who have enrolled under another Laboratory of Immunoregulation (LIR) protocol and had samples drawn prior to vaccination will also be eligible for enrollment. Inclusion Criteria for Secondary (Booster) Vaccination Group: 1\. Willingness to return for baseline research blood collection prior to booster vaccination. EXCLUSION CRITERIA: 1. Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance. 2. Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Susan L Moir, Ph.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Catherine A Seamon, R.N.
- Email: cseamon@cc.nih.gov
- Phone: (301) 402-3481
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.