Investigating Immune Escape by SARS-CoV-2 Variants

NCT ID: NCT05171803

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-29

Study Completion Date

2023-10-15

Brief Summary

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The purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants.

Detailed Description

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Several variants of the SARS-CoV-2 virus were identified in 2020 including the United Kingdom variant (known as 20I/501Y.V1, VOC 202012/01, or B.1.1.7), South Africa variant (known as 20H/501Y.V2 or B.1.35), and Brazil variant (known as P.1), with more variants still being discovered. There is concern that these variants, due to mutations in spike protein and receptor-binding domain of the spike protein, can be more infectious, lethal, and potentially escape the immune responses from vaccination or prior infection. Research is needed to understand the risks associated with currently known variants of SARS-CoV-2 as well as investigate if there is potential for new mutations to form that would allow SARS-CoV-2 variants to partially or entirely escape the immune mechanisms developed from vaccination and/or prior infection from the wild-type strain of SARS-CoV-2.

Conditions

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COVID-19; Immunity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention

No intervention, prospective, cohort study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People who have been fully vaccinated for COVID-19 2-12 weeks prior to enrollment or individuals \<3 months post-COVID-19 infection.
* Collection of samples for blood samples will be done only from healthy, nonpregnant adults who weigh at least 110 pounds.
* Participants must be able to provide informed consent.

Exclusion Criteria

-Subjects considered vulnerable including children, pregnant women, nursing home residents, or other institutionalized persons, fetuses, prisoners, and persons without decisional capacity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advarra

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Noah Kojima, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Curative

San Dimas, California, United States

Site Status

Countries

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United States

Other Identifiers

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PTL-2021-0007

Identifier Type: -

Identifier Source: org_study_id

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