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The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19) (BOOSTED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05268185
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
While both heterologous (mixing) and homologous (matching) vaccine regimens are now considered standard of care, post-vaccination complications and long-term effects of the different vaccination regimens have not been thoroughly studied. There is a pressing need to investigate the longitudinal effects of the mixing and matching vaccine-booster approaches. This study proposes to utilize the existing digital infrastructure of the COVID-19 Citizen Science (CCS) study on the Eureka Research Platform to perform a systematic and prospective randomized trial comparing mixing versus matching approaches. Eligible CCS participants will have the opportunity to be randomly assigned to a recommendation of receiving either the Pfizer or Moderna booster vaccine. Long-term effects will be monitored through the participants' completion of their regular weekly CCS follow-up surveys on symptoms and infection. This randomized trial aims to mitigate the effect of confounding variables and provide more conclusive evidence on each regiment to guide booster recommendations.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Reaction COVID-19 Pandemic Behavioral: Moderna Booster Vaccine Behavioral: Pfizer Booster Vaccine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Assess Differences Between Mixing or Matching of Moderna and Pfizer Booster Vaccines for Covid-19 Citizen Science (CCS) Participants
Actual Study Start Date : January 18, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


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.
Behavioral: Moderna Booster Vaccine
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.

Active Comparator: Pfizer Booster Recommendation
Participants assigned to this arm will be recommended to receive the Pfizer vaccine for their Covid-19 booster shot.
Behavioral: Pfizer Booster Vaccine
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.




Primary Outcome Measures :
  1. Post-Vaccine Differences in Types of Symptoms between Pfizer and Moderna [ Time Frame: 1 year ]
    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.

  2. Post-Vaccine Differences in Severity of Symptoms between Pfizer and Moderna [ Time Frame: 1 year ]
    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).

  3. Post-Vaccine Differences in Types of Symptoms between Homologous vs Heterologous Regiments [ Time Frame: 1 year ]
    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.

  4. Post-Vaccine Differences in Severity of Symptoms between Homologous vs Heterologous Regiments [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. COVID-19 Infection Rates between Pfizer and Moderna [ Time Frame: 1 year ]
    The study will compare COVID-19 infection rates among those who receive the Moderna booster vs. the Pfizer booster

  2. COVID-19 Infection Rates between Homologous vs Heterologous Regiments [ Time Frame: 1 year ]
    The study will compare COVID-19 infection rates among those with homologous vs. heterologous vaccine regimens.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05268185


Locations
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United States, California
UCSF Parnassus
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Greg Marcus, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] January 6, 2022

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05268185    
Other Study ID Numbers: 21-35575
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
COVID-19
Remote
Vaccine
COVID-19 Citizen Science Study
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs