Investigating Immune Escape by SARS-CoV-2 Variants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05171803

Enrollment

Registered

2021-12-29

Start date

2021-05-29

Completion date

2023-10-15

Last updated

2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19; Immunity

Brief summary

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

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.

Interventions

OTHERNo intervention

No intervention, prospective, cohort study.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Assessing immunity	1 year	Assess immune escape among people with vaccination or natural immunity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026