Investigating Immune Escape by SARS-CoV-2 Variants

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Immunity
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • California
    • San Dimas, California, United States, 91773
      • Curative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults living in Los Angeles County

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Advarra

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PTL-2021-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This will not be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No