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Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05078905
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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.

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.

...


Condition or disease
COVID-19 Vaccination Healthy Volunteer

Detailed Description:

Study Description: This protocol will enroll up to 200 adults per year who are scheduled to be vaccinated against severe acute respiratory syndromecoronavirus 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:

  1. Evaluate baseline correlates of immune response to vaccination.
  2. Correlate cellular and serologic responses after vaccination.
  3. For vaccines that require two or more doses; characterize the immunologic responses following both the primary (new) and

    the secondary (booster) dose(s).

  4. 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : January 1, 2050
Estimated Study Completion Date : January 1, 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Group/Cohort
Individuals Receiving Vaccine
Individuals receiving a vaccination for an emerging infection, like SARS-CoV-2



Primary Outcome Measures :
  1. Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections. [ Time Frame: throughout ]
    Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals greater than 18 years of age who are scheduled to receive a initial or booster vaccination to an emerging infectious disease.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05078905


Contacts
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Contact: Catherine A Seamon, R.N. (301) 402-3481 cseamon@cc.nih.gov
Contact: Susan Moir, Ph.D. (301) 402-4559 sm221a@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Susan Moir, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05078905    
Other Study ID Numbers: 10000688
000688-I
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 5, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .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.
Supporting Materials: Study Protocol
Time Frame: Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.@@@@@@Genomic data will be shared following the guidelines of the Genomic Data Sharing Policy, when applicable.
Access Criteria: Identified data in BTRIS (automatic for activities in the Clinical Center and will be available for use following the BTRIS Policy for Data Sharing and Use).@@@@@@De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@De-identified genomic data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) and the use of the data within will be governed by their policies.@@@@@@01

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Vaccination
Pandemic
COVID-19
Pathogens
Immune Response
Natural History
Additional relevant MeSH terms:
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COVID-19
Communicable Diseases
Infections
Communicable Diseases, Emerging
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes