Coronavirus InfectionsNCT05516459
Prospective Monitoring of BNT162b2 Second Vaccination Booster Effects in Health Care Workers (HCW)
An observational study of Coronavirus Infections, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The SARS-CoV-2 virus causes severe respiratory illness and is an ongoing global pandemic. On December 12, 2020 the FDA approved Pfizer's BioNTech vaccine BNT162b2 which is a messenger RNA type of vaccine for use. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- Pfizer BNT162b2 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 635 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2022to Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be screened at each participating medical center. The study population will be enrolled according to the following inclusion and exclusion criteria.
Who may be able to join
- Able to provide written informed consent.
- Healthcare worker in one of the Clalit Health Services Medical centers and is at least 18 years of age.
- Completed three doses of BNT162b2 according to MOH guidelines.
- Third dose was given at least 4 months prior to enrollment.
Who cannot join
- History of COVID-19 infection.
- History of being treated or is currently being treated for any type of Malignancies or other co-morbid conditions that may result in protocol non-compliance.
- Currently or in the past three months was treated with any type of Immune suppression medication (including chemotherapy, immunomodulatory drugs, biological agents that affect the immune system, any immunosuppressive drug such as corticosteroids).
- Received in the past 4 months monoclonal antibodies of any type.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Monitoring of BNT162b2 Second Vaccination Booster for Prevention of the COVID-19 Infection in Health Care Workers (HCW)
The SARS-CoV-2 virus causes severe respiratory illness and is an ongoing global pandemic. On December 12, 2020 the FDA approved Pfizer's BioNTech vaccine BNT162b2 which is a messenger RNA type of vaccine for use. This vaccine has shown in numerous studies the ability to induce a strong immune response and provide both humeral and cellular protection against wild type, alpha and delta variants of SARS-CoV2 virus.
In Israel the national vaccine operation began in mid-December 2020 which included 2 initial doses three weeks apart. In August 2021 a first booster (3rd dose) was provided to enhance protection and due to reports of reduced immune response and clinical protection. Several studies have demonstrated that over time there is a decay in the antibody levels, and with them reduced protection.
Read more
Recently a new variant of concern has been identified (Omicron) and is causing a surge of infections worldwide. There is lack of knowledge regarding the effectiveness of the current schedule of vaccine against this new variant and whether a second booster (4th dose) will provide higher levels of clinical protection against this variant, currently the ministry of health is considering recommendations for a fourth dose for HCW.
The purpose of this study is to examine whether a fourth dose of vaccination will provide better protection against infection and clinical disease.
- Conditions
- Coronavirus Infections
- Being tested
- Pfizer BNT162b2 Vaccine
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer BNT162b2 VaccineBiological
The Pfizer-BioNTech COVID-19 vaccine (INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in people aged five years and older in some jurisdictions, twelve years and older in some jurisdictions, and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada
| Study group | Role | What they receive |
|---|---|---|
| Three doses of vaccination | Subjects received three pfizer BNT162b2 vaccination at least four month before recruitment | |
| Four doses of vaccination | Subjects received three pfizer BNT162b2 vaccination at least four month before recruitment and decided to receive another dose at time of recruitment or followup Receives: Biological: Pfizer BNT162b2 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
Measured: 30 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
Measured: 60 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
Measured: 90 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
Measured: 120 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
Measured: 150 days
Secondary outcomes (13)
Proportion of symptomatic COVID 19 infection
Percent Positive PCR test
Measured: 30 days
Proportion of symptomatic COVID 19 infection
Percent Positive PCR test
Measured: 90 days
Proportion of symptomatic COVID 19 infection
Percent Positive PCR test
Measured: 182 days
Proportion of COVID 19 infection requiring hospitalization
Percent Positive PCR test
Measured: 30days
Proportion of COVID 19 infection requiring hospitalization
Percent Positive PCR test
Measured: 90 days
Proportion of COVID 19 infection requiring hospitalization
Percent Positive PCR test
Measured: 182 days
Levels of binding and neutralizing activity and avidity of the antibodies
binding antibody units per mL
Measured: 30 days
Levels of binding and neutralizing activity and avidity of the antibodies
50 Percent neutralization titer
Measured: 60 days
Levels of binding and neutralizing activity and avidity of the antibodies
50 Percent neutralization titer
Measured: 90 days
Levels of binding and neutralizing activity and avidity of the antibodies
50 Percent neutralization titer
Measured: 120 days
Levels of binding and neutralizing activity and avidity of the antibodies
50 Percent neutralization titer
Measured: 150 days
Levels of binding and neutralizing activity and avidity of the antibodies
50 Percent neutralization titer
Measured: 180 days
Composite endpoint of serious adverse events
Percent Positive Anaphylaxis, Myocarditis
Measured: 14 days following the booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start6 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Victor Novack, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516459
- Sponsor's protocol ID
- SCRC22001
- Status last verified
- May 2023
- First submitted
- 21 Aug 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Unidentified participant data will be made available when the study is complete upon requests directed to the corresponding author. Proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement. All data will be made available for a minimum of 5 years from the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monitoring of BNT162b2 Second Vaccination Booster for Prevention of the COVID-19 Infection in Health Care Workers (HCW)
- ClinicalTrials.gov ID
- NCT05516459
- Acronym / sponsor ID
- SCRC22001
- Conditions
- Coronavirus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Aug 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.
The SARS-CoV-2 virus causes severe respiratory illness and is an ongoing global pandemic. On December 12, 2020 the FDA approved Pfizer's BioNTech vaccine BNT162b2 which is a messenger RNA type of vaccine for use. This vaccine has shown in numerous studies the ability to induce a strong immune response and provide both humeral and cellular protection against wild type, alpha and delta variants of SARS-CoV2 virus.
In Israel the national vaccine operation began in mid-December 2020 which included 2 initial doses three weeks apart. In August 2021 a first booster (3rd dose) was provided to enhance protection and due to reports of reduced immune response and clinical protection. Several studies have demonstrated that over time there is a decay in the antibody levels, and with them reduced protection.
Recently a new variant of concern has been identified (Omicron) and is causing a surge of infections worldwide. There is lack of knowledge regarding the effectiveness of the current schedule of vaccine against this new variant and whether a second booster (4th dose) will provide higher levels of clinical protection against this variant, currently the ministry of health is considering recommendations for a fourth dose for HCW.
The purpose of this study is to examine whether a fourth dose of vaccination will provide better protection against infection and clinical disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three doses of vaccination | – | –Subjects received three pfizer BNT162b2 vaccination at least four month before recruitment |
| Four doses of vaccination | – | Biological: Pfizer BNT162b2 VaccineSubjects received three pfizer BNT162b2 vaccination at least four month before recruitment and decided to receive another dose at time of recruitment or followup |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be screened at each participating medical center. The study population will be enrolled according to the following inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Able to provide written informed consent.
- Healthcare worker in one of the Clalit Health Services Medical centers and is at least 18 years of age.
- Completed three doses of BNT162b2 according to MOH guidelines.
- Third dose was given at least 4 months prior to enrollment.
Key exclusion criteria (4 listed)
- History of COVID-19 infection.
- History of being treated or is currently being treated for any type of Malignancies or other co-morbid conditions that may result in protocol non-compliance.
- Currently or in the past three months was treated with any type of Immune suppression medication (including chemotherapy, immunomodulatory drugs, biological agents that affect the immune system, any immunosuppressive drug such as corticosteroids).
- Received in the past 4 months monoclonal antibodies of any type.
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 |
|---|---|---|
| Pfizer BNT162b2 VaccineThe Pfizer-BioNTech COVID-19 vaccine (INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in people aged five years and older in some jurisdictions, twelve years and older in some jurisdictions, and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada | Biological | Four doses of vaccination |
Primary outcome
Proportion of positive PCR test for SARS-COV2
Time frame: 30 days
Percent Positive PCR test
Proportion of positive PCR test for SARS-COV2
Time frame: 60 days
Percent Positive PCR test
Proportion of positive PCR test for SARS-COV2
Time frame: 90 days
Percent Positive PCR test
Proportion of positive PCR test for SARS-COV2
Time frame: 120 days
Percent Positive PCR test
Proportion of positive PCR test for SARS-COV2
Time frame: 150 days
Percent Positive PCR test
13 secondary outcomes
Proportion of symptomatic COVID 19 infection
Time frame: 30 days
Proportion of symptomatic COVID 19 infection
Time frame: 90 days
Proportion of symptomatic COVID 19 infection
Time frame: 182 days
Proportion of COVID 19 infection requiring hospitalization
Time frame: 30days
Proportion of COVID 19 infection requiring hospitalization
Time frame: 90 days
Proportion of COVID 19 infection requiring hospitalization
Time frame: 182 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 30 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 60 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 90 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 120 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 150 days
Levels of binding and neutralizing activity and avidity of the antibodies
Time frame: 180 days
Composite endpoint of serious adverse events
Time frame: 14 days following the booster vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No. Unidentified participant data will be made available when the study is complete upon requests directed to the corresponding author. Proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement. All data will be made available for a minimum of 5 years from the end of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by Soroka University Medical Center at 1 site in Israel.
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 4 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 6 May 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 Israel. 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?
Results are not available in the source record.
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?
Proportion of positive PCR test for SARS-COV2 (time frame: 30 days). The study lists 5 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 6 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.