SARS-CoV2 InfectionPhase 4NCT04978038
Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs
A Phase 4 study testing mRNA- COVID-19 and Prevnar13 in people with SARS-CoV2 Infection and Coronavirus Infection, run by Mark Loeb at 1 site in Canada.
Trial summary
This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, Coronavirus Infection
- What is being tested?
- mRNA- COVID-19 and Prevnar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 31 Dec 2022
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.
Who cannot join
- Immunocompromised individuals due to known or suspected immunodeficiency or due to receipt of immunosuppressive medication (e.g., steroids, biologics).
- Having had a severe adverse reaction (e.g., anaphylactic allergy) to mRNA or pneumococcal vaccine.
- Having received pneumococcal polysaccharide vaccine within 12 months.
- LTCF residents who have an interval less than 3 months from their third mRNA COVID vaccine dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).
Read the detailed description
The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.
- Conditions
- SARS-CoV2 Infection, Coronavirus Infection
- Being tested
- mRNA- COVID-19, Prevnar13
- Keywords
- COVID-19, Immunization, Long-term care
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA- COVID-19Drug
Also called Pfizer-BioNtech mRNA- COVID-19
Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly
Prevnar13Drug
Also called Pneumococcal Vaccine
Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Pfizer-BioNtech mRNA- COVID-19 | Experimental | Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly. Receives: Drug: mRNA- COVID-19 |
| Pneumococcal Prevnar-13 | Active comparator | Eligible participants will be vaccinated with Pfizer Prevar-13 (pneumococcal vaccine) in a blinded manner such that the vaccination with Pfizer-BioNtech mRNA- COVID-19 will be mimicked. That is, a 0.5ml dose of the vaccine will be administered intramuscularly. After completion of the study participants in the control arm will be given a fourth dose of Pfizer-BioNtech mRNA- COVID-19. Receives: Drug: Prevnar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of neutralizing antibodies
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.
Measured: 28 days
Secondary outcomes (5)
Total IgG spike response
Secondary Outcome measured using in-house assay for IgG spike protein response
Measured: 28 Days
Total IgM spike response
Secondary Outcome measured using in-house assay for IgM spike protein response
Measured: 28 Days
IgA spike antibodies titre
Secondary Outcome measured using in-house assay for IgA spike protein titre
Measured: 28 Days
Anti-RBD antibody titre
Secondary Outcome measured using in-house assay for Anti-RBD antibody titre
Measured: 28 Days
ADCC Response
Secondary Outcome measured using in-house assay for ADCC response
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2022 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Loeb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Loeb, McMaster University
- Investigators
- Mark Loeb, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978038
- Sponsor's protocol ID
- mRNA-COVID19-D3-2021
- Status last verified
- Jun 2022
- First submitted
- 20 Jul 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Personal identification information removed and assigned a number. Information linked ID to identifying information stored securely at McMaster. Only vaccine administration will have access to identifying information. No personal identification will be published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT04978038
- Acronym / sponsor ID
- mRNA-COVID19-D3-2021
- Conditions
- SARS-CoV2 Infection, Coronavirus Infection
- Keywords
- COVID-19, Immunization, Long-term care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Mark LoebUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Jul 2021 (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.
This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).
Detailed description
The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Pfizer-BioNtech mRNA- COVID-19 | Experimental | Drug: mRNA- COVID-19Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly. |
| Pneumococcal Prevnar-13 | Active comparator | Drug: Prevnar13Eligible participants will be vaccinated with Pfizer Prevar-13 (pneumococcal vaccine) in a blinded manner such that the vaccination with Pfizer-BioNtech mRNA- COVID-19 will be mimicked. That is, a 0.5ml dose of the vaccine will be administered intramuscularly. After completion of the study participants in the control arm will be given a fourth dose of Pfizer-BioNtech mRNA- COVID-19. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.
Key exclusion criteria (4 listed)
- Immunocompromised individuals due to known or suspected immunodeficiency or due to receipt of immunosuppressive medication (e.g., steroids, biologics).
- Having had a severe adverse reaction (e.g., anaphylactic allergy) to mRNA or pneumococcal vaccine.
- Having received pneumococcal polysaccharide vaccine within 12 months.
- LTCF residents who have an interval less than 3 months from their third mRNA COVID vaccine dose.
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 |
|---|---|---|
| mRNA- COVID-19Also: Pfizer-BioNtech mRNA- COVID-19Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly | Drug | Pfizer-BioNtech mRNA- COVID-19 |
| Prevnar13Also: Pneumococcal VaccinePfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly | Drug | Pneumococcal Prevnar-13 |
Primary outcome
Detection of neutralizing antibodies
Time frame: 28 days
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.
5 secondary outcomes
Total IgG spike response
Time frame: 28 Days
Total IgM spike response
Time frame: 28 Days
IgA spike antibodies titre
Time frame: 28 Days
Anti-RBD antibody titre
Time frame: 28 Days
ADCC Response
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No. Personal identification information removed and assigned a number. Information linked ID to identifying information stored securely at McMaster. Only vaccine administration will have access to identifying information. No personal identification will be published.
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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.
Mark Loeb, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mRNA- COVID-19 and Prevnar13 in people with SARS-CoV2 Infection and Coronavirus Infection, run by Mark Loeb at 1 site in Canada.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Loeb, MD (905-525-9140 ext. 26066, loebm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of neutralizing antibodies (time frame: 28 days). 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 30 Jun 2022.