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

NCT05268185 | Completed DMC

• 1 other identifier: 21-35575
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine Reaction; COVID-19 Pandemic

Keywords

COVID-19; Remote; Vaccine; COVID-19 Citizen Science Study

Outcome Measures

Primary Outcomes (4)

• Post-Vaccine Differences in Types of Symptoms between Pfizer and Moderna

  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.

  1 year

• Post-Vaccine Differences in Severity of Symptoms between Pfizer and Moderna

  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).

  1 year

• Post-Vaccine Differences in Types of Symptoms between Homologous vs Heterologous Regiments

  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.

  1 year

• Post-Vaccine Differences in Severity of Symptoms between Homologous vs Heterologous Regiments

  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).

  1 year

Secondary Outcomes (2)

• COVID-19 Infection Rates between Pfizer and Moderna

  1 year

• COVID-19 Infection Rates between Homologous vs Heterologous Regiments

  1 year

Study Arms (2)

Moderna Booster Recommendation

ACTIVE COMPARATOR

Participants assigned to this arm will be recommended to receive the Moderna vaccine for their Covid-19 booster shot.

Behavioral: Moderna Booster Vaccine

Pfizer Booster Recommendation

ACTIVE COMPARATOR

Participants assigned to this arm will be recommended to receive the Pfizer vaccine for their Covid-19 booster shot.

Behavioral: Pfizer Booster Vaccine

Interventions

Moderna Booster Vaccine BEHAVIORAL

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.

Moderna Booster Recommendation

Pfizer Booster Vaccine BEHAVIORAL

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.

Pfizer Booster Recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Parnassus

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Greg Marcus, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 7, 2022
• Study Start: January 18, 2022
• Primary Completion: March 31, 2022
• Study Completion: January 18, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)