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

• ClinicalTrials.gov Identifier: NCT05268185
• Recruitment Status: Enrolling by invitation
• First Posted: March 7, 2022
• Last Update Posted: March 7, 2022
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, California

UCSF Parnassus

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• 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

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05268185
• Other Study ID Numbers: 21-35575
• First Posted: March 7, 2022
• Last Update Posted: March 7, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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