COVID-19BOOSTEDNCT05268185
The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19)
A study testing Moderna Booster Vaccine and Pfizer Booster Vaccine in people with COVID-19 and Vaccine Reaction, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Reaction, COVID-19 Pandemic
- What is being tested?
- Moderna Booster Vaccine and Pfizer Booster Vaccine
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Vaccine Reaction, COVID-19 Pandemic
- Being tested
- Moderna Booster Vaccine, Pfizer Booster Vaccine
- Keywords
- COVID-19, Remote, Vaccine, COVID-19 Citizen Science Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderna Booster VaccineBehavioural
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.
Pfizer Booster VaccineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderna Booster Recommendation | Active comparator | Participants assigned to this arm will be recommended to receive the Moderna vaccine for their Covid-19 booster shot. Receives: 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. Receives: Behavioral: Pfizer Booster Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 1 year
Secondary outcomes (2)
COVID-19 Infection Rates between Pfizer and Moderna
The study will compare COVID-19 infection rates among those who receive the Moderna booster vs. the Pfizer booster
Measured: 1 year
COVID-19 Infection Rates between Homologous vs Heterologous Regiments
The study will compare COVID-19 infection rates among those with homologous vs. heterologous vaccine regimens.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start18 Jan 2022
- Primary completion31 Mar 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Marcus, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268185
- Sponsor's protocol ID
- 21-35575
- Acronym
- BOOSTED
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05268185
- Acronym / sponsor ID
- BOOSTED / 21-35575
- Conditions
- COVID-19, Vaccine Reaction, COVID-19 Pandemic
- Keywords
- COVID-19, Remote, Vaccine, COVID-19 Citizen Science Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderna Booster Recommendation | Active comparator | Behavioral: Moderna Booster VaccineParticipants assigned to this arm will be recommended to receive the Moderna vaccine for their Covid-19 booster shot. |
| Pfizer Booster Recommendation | Active comparator | Behavioral: Pfizer Booster VaccineParticipants assigned to this arm will be recommended to receive the Pfizer vaccine for their Covid-19 booster shot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderna Booster VaccineParticipants 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. | Behavioural | Moderna Booster Recommendation |
| Pfizer Booster VaccineParticipants 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. | Behavioural | Pfizer Booster Recommendation |
Primary outcome
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.
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).
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.
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).
2 secondary outcomes
COVID-19 Infection Rates between Pfizer and Moderna
Time frame: 1 year
COVID-19 Infection Rates between Homologous vs Heterologous Regiments
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Marcus, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderna Booster Vaccine and Pfizer Booster Vaccine in people with COVID-19 and Vaccine Reaction, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Vaccine Differences in Types of Symptoms between Pfizer and Moderna (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.