NCT05212610

Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction

Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID"). Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits. We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated. The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.

Conditions

• COVID-19
• Corona Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pfizer-BioNTech mRNA COVID-19 vaccine	Participants will receive an initial or additional dose of a highly protective COVID-19 mRNA vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in an environment where the investigators and staff are experienced in the care of patients with allergic reactions.
BIOLOGICAL	Moderna mRNA COVID-19 vaccine	Participants will receive an initial or additional dose of a highly protective COVID-19 mRNA vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in an environment where the investigators and staff are experienced in the care of patients with allergic reactions.

Timeline

• Start date: 2022-03-21
• Primary completion: 2025-03-07
• Completion: 2025-03-07
• First posted: 2022-01-28
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study