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mRNA Vaccine

Open-Label Booster Vaccine for Anaphylaxis

Phase 2
Waitlist Available
Led By Pamela A Guerrerio, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the 3-hour post-vaccine observation period
Awards & highlights

Study Summary

This trial is studying the safety of giving a 2nd dose of COVID-19 vaccine to people who had a systemic allergic reaction to their 1st dose. People aged 16-69 who had an allergic reaction to their 1st dose of COVID-19 vaccine are eligible to participate.

Eligible Conditions
  • Anaphylaxis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the 3-hour post-vaccine observation period
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the 3-hour post-vaccine observation period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Who Had Recurrent Systemic Allergic Reaction to Vaccine
Secondary outcome measures
Proportion of Participants Who Developed Anaphylactic Reaction Following Active Dose Delivered
Proportion of Participants Who Developed Anaphylactic Reaction Following Active Vaccine Dose
Proportion of Participants Who Developed Mild or Moderate Systemic Allergic Reaction Following Active Vaccine Dose
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open-Label Booster VaccineExperimental Treatment2 Interventions
Participants who did not suffer from a COFAR grade 3 or higher reaction after blinded active vaccine 2 were offered to receive booster dose of the active mRNA COVID-19 vaccine (0.3 mL) intramuscularly 5 months later.
Group II: Blinded Active Vaccine 2Active Control2 Interventions
Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly followed by a wash out period of 24 hours then crossover to receive placebo (0.3 mL normal saline) intramuscularly.
Group III: Blinded PlaceboPlacebo Group2 Interventions
Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the placebo (0.3 mL normal saline) intramuscularly followed by a wash out period of 24 hours then crossover to receive the active mRNA COVID-19 vaccine (0.3mL) intramuscularly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
2021
Completed Phase 2
~20
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,986 Total Patients Enrolled
4 Trials studying Anaphylaxis
1,089 Patients Enrolled for Anaphylaxis
Pamela A Guerrerio, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
3,698 Total Patients Enrolled
1 Trials studying Anaphylaxis
773 Patients Enrolled for Anaphylaxis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of 55 allowed to partake in this medical experiment?

"Participants aged 16 to 69 are eligible for this trial. For those younger than 16, there are 227 clinical trials available; conversely, 1077 medical studies exist for patients older than 65."

Answered by AI

Who has the capability to partake in this clinical research?

"A total of 17 individuals have been recruited into this trial, aged 16-69 years old who has previously experienced a systemic allergic reaction to either the Pfizer-BioNTech or Moderna COVID-19 vaccine. Aside from meeting these criteria, participants must also be able to provide informed consent and agree with all study procedures (such as forgoing medications if needed). Furthermore, they need an outside medical practitioner that will manage their health care beyond this particular experiment and guarantee availability throughout its duration. The time since receiving the first dose of either vaccine should not exceed 28 days in case of Moderna's nor 21 days for those vaccinated with the"

Answered by AI

Has the Active Vaccine been granted authorization by the FDA?

"Our team at Power has assigned a safety rating of 2 to the Active Vaccine due to its Phase 2 status, indicating that while some evidence exists in regards to its safety, there is none concerning efficacy."

Answered by AI

Is this trial a pioneering effort in its field?

"BioNTech SE's Active Vaccine is being evaluated in 27 concurrent trials, occurring in 220 cities and 27 countries. This medication was first tested on 512 volunteers at the start of 2020, and has since completed Phase 1 & 2 drug approval stage. As a result, 18333 studies have been successfully concluded by now."

Answered by AI

How many participants are involved in this research endeavor?

"At this time, enrollment for the aforementioned clinical trial has closed. It was first listed on September 8th 2021 and last updated November 10th 2022. Thankfully, there are still 1284 investigations recruiting patients with systemic allergic reaction and 27 trials actively searching for participants to test an active vaccine."

Answered by AI

Has recruitment for this experiment already begun?

"At this juncture, no new patients are being sought for the clinical trial. It was first posted on September 8th 2021 and was last edited November 10th 2022. For those seeking other trials, 1284 studies currently recruiting participants with systemic allergic reaction have been identified as well as 27 medical studies recruiting individuals interested in Active Vaccine therapies."

Answered by AI

Has there been previous research into the efficacy of Active Vaccine?

"At present, 27 experiments are being implemented with Active Vaccine. 6 of these trials have progressed to Phase 3 testing and the majority take place in Roskilde or Aarhus N; 762 other medical institutions globally are running research on this vaccine."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Mar 2025