Investigating Immune Escape by SARS-CoV-2 Variants

Completed

• Conditions: COVID-19; Immunity

• Registration Number: NCT05171803
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study Start: 2021-05-29
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-29
• Primary Completion: 2022-12-31
• Study Completion: 2023-10-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing immunity	1 year	Assess immune escape among people with vaccination or natural immunity

Trial Locations

Locations (1)

Curative; 🇺🇸 San Dimas, California, United States