COVID-19NCT05078905
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
An observational study of COVID-19 and Vaccination, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccination, Healthy Volunteer
- Type of treatment
- Vaccines
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 1 Jan 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals greater than 18 years of age who are scheduled to receive a initial or booster vaccination to an emerging infectious disease.
Who may be able to join
- 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:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older
- Hemoglobin >= 9.0 grams per deciliter (g/dL) or >= 11.2 for women who are pregnant.
- Willingness to give consent for the storage of blood samples for research
Show all 10Show fewer
- Ability of subject to understand and the willingness to sign a written informed consent document
- 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.
Who cannot join
- Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
- Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
Background:
Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why.
Read more
Objective:
To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2.
Eligibility:
Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection.
Design:
Participants will be screened with a medical history and blood and urine tests.
Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health.
After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH.
This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines.
...
Read the detailed description
Study Description: This protocol will enroll up to 200 adults per year who are scheduled to be vaccinated against severe acute respiratory syndromecorona virus 2 (SARS-CoV-2) or other emerging pathogens. Participants will provide blood samples prior to and serially aftervaccination. The blood will be used to perform research studies of the immune response to primary (new) and secondary (booster) vaccines.
Objectives:
Primary Objective: Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.
Secondary Objectives:
- Evaluate baseline correlates of immune response to vaccination.
- Correlate cellular and serologic responses after vaccination.
- For vaccines that require two or more doses; characterize the immunologic responses following both the primary (new) and the secondary (booster) dose(s).
- Evaluate the longevity of immune responses to primary (new) and secondary (booster) vaccination.
Endpoints: Primary Endpoint: Establish immunologically well characterized cohorts of primary (new) and secondary (booster) vaccinated individuals.
Secondary Endpoints: Establish factors associated with longevity of serologic and cellular responses to primary (new) and secondary (booster) vaccination.
- Conditions
- COVID-19, Vaccination, Healthy Volunteer
- Keywords
- Vaccination, Pandemic, COVID-19, Pathogens, Immune Response, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals Receiving Vaccine | Individuals receiving a vaccination for an emerging infection, like SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.
Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.
Measured: throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start13 Oct 2021
- Primary completion1 Jan 2050 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan L Moir, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078905
- Sponsor's protocol ID
- 10000688
- Other IDs
- 000688-I
- Status last verified
- 28 Jul 2026
- First submitted
- 13 Oct 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identified data in BTRIS (automatic for activities in the Clinical Center). De-identified or identified data with approved outside collaborators under appropriate agreements. This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. De-identified data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) or in NCBI Virus Portal for viral sequencing.