- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268185
The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19) (BOOSTED)
A Randomized Controlled Trial to Assess Differences Between Mixing or Matching of Moderna and Pfizer Booster Vaccines for Covid-19 Citizen Science (CCS) Participants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The FDA recently approved the use of COVID-19 booster vaccines for both homologous and heterologous vaccine booster regimens, with both regimens considered standard of care. However, there is incomplete research on the long-term effects and immunity offered by each approach. In fact, the FDA has not offered guidance on whether or not to mix or match vaccines because as of yet, there is no evidence indicating that one strategy should be recommended over the other. Studies have shown that vaccine efficacy declines over time, and the Delta and Omicron variants continue to cause breakthrough cases. Additionally, millions of Americans are now becoming eligible for a booster. These factors present both a pressing need and a unique opportunity to investigate the longitudinal effects of the mixing and matching vaccine-booster approaches.
This study proposes to fill this critical gap through a systematic and prospective randomized trial utilizing the existing digital infrastructure of the COVID-19 Citizen Science (CCS) study on the Eureka Research Platform. Eligible CCS participants will have the opportunity to be randomly assigned to be encouraged to receive either the BNT162b2 (Pfizer) or mRNA-1273 (Moderna) booster vaccine and will continue to complete their weekly CCS follow up surveys on symptoms and infection. Thus, this study will allow for longitudinal follow up of participants receiving homologous and heterologous vaccine booster regimens. By randomizing participants and analyzing a larger cohort, this study aims to mitigate the effect of confounding variables and provide more conclusive evidence to guide booster recommendations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- UCSF Parnassus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be enrolled in the COVID19 Citizen Science (CCS) study. The CCS study is a remote, longitudinal, observational registry hosted on the Eureka Research Platform that administers weekly questionnaires to participants regarding COVID-19 symptoms and exposures. CCS is currently open to enrollment for adults aged 18 and older who have a smartphone device to participate on the mobile app, or an email address to participate on the web portal.
- Must have received either 2 doses of mRNA vaccine such as Moderna and Pfizer, or 1 dose of Johnson and Johnson
Exclusion Criteria:
- Already received a COVID19 booster
- Are not planning on receiving a COVID19 booster in the next 3 months
- Do not have equal access to both the Pfizer and Moderna boosters
- Have a medical reason to receive either the Pfizer or Moderna booster
- Have a medical reason to not receive any booster (e.g h/o allergic reaction to an mRNA vaccine or myocarditis or pericarditis after an mRNA vaccine)
- Are unwilling to be randomized
- Are unable to commit to filling out the CCS weekly surveys consistently (to the best of their ability)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Moderna Booster Recommendation
Participants assigned to this arm will be recommended to receive the Moderna vaccine for their Covid-19 booster shot.
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Participants assigned to this intervention will be given the recommendation to receive the Moderna vaccine for their Covid-19 booster shot.
The study team will not be administering vaccines to the participants; participants must have equal access to both the Pfizer and Moderna booster vaccines to be eligible for this study.
According to current FDA recommendations, Moderna booster (0.25 mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine.
The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
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Active Comparator: Pfizer Booster Recommendation
Participants assigned to this arm will be recommended to receive the Pfizer vaccine for their Covid-19 booster shot.
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Participants assigned to this intervention will be given the recommendation to receive the Pfizer vaccine for their Covid-19 booster shot.
The study team will not be administering vaccines to the participants; participants must have equal access to both the Pfizer and Moderna booster vaccines to be eligible for this study.
According to current FDA recommendations, the Pfizer booster (0.30 mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine.
The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Vaccine Differences in Types of Symptoms between Pfizer and Moderna
Time Frame: 1 year
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The study will assess differences in types of symptoms participants experience post-vaccination between the randomization groups (Pfizer vs. Moderna).
The types of symptoms will be assessed through a questionnaire post-vaccination asking participants if they have any of the following symptoms: fever, chills, fatigue, sore/scratchy throat, muscle pain, joint pain, headache, other pain, rash, allergic reaction/anaphylaxis.
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1 year
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Post-Vaccine Differences in Severity of Symptoms between Pfizer and Moderna
Time Frame: 1 year
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The study will assess differences in severity participants experience post-vaccination between the randomization groups (Pfizer vs. Moderna).
The severity for each symptom will be assessed through a post-vaccination questionnaire asking participants how many days the participant experienced their symptoms, and how severe their symptoms were on a scale of 1 to 5 (1 being mild, 5 being very severe).
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1 year
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Post-Vaccine Differences in Types of Symptoms between Homologous vs Heterologous Regiments
Time Frame: 1 year
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The study will assess differences in types of symptoms participants experience post-vaccination between people who receive the same type of booster vaccine as their initial series (homologous) and people who receive a different type of booster vaccine than their initial series (heterologous) regiments.
The types of symptoms will be assessed through a questionnaire post-vaccination asking participants if they have any of the following symptoms: fever, chills, fatigue, sore/scratchy throat, muscle pain, joint pain, headache, other pain, rash, allergic reaction/anaphylaxis.
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1 year
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Post-Vaccine Differences in Severity of Symptoms between Homologous vs Heterologous Regiments
Time Frame: 1 year
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The study will assess differences in severity of symptoms participants experience post-vaccination between people who receive the same type of booster vaccine as their initial series (homologous) and people who receive a different type of booster vaccine than their initial series (heterologous) regiments.
The severity of each symptom will be assessed through a post-vaccination questionnaire asking participants how many days the participant experienced their symptoms, and how severe their symptoms were on a scale of 1 to 5 (1 being mild, 5 being very severe).
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 Infection Rates between Pfizer and Moderna
Time Frame: 1 year
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The study will compare COVID-19 infection rates among those who receive the Moderna booster vs. the Pfizer booster
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1 year
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COVID-19 Infection Rates between Homologous vs Heterologous Regiments
Time Frame: 1 year
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The study will compare COVID-19 infection rates among those with homologous vs. heterologous vaccine regimens.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Greg Marcus, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-35575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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