Prospective Monitoring of BNT162b2 Second Vaccination Booster Effects in Health Care Workers (HCW)
1 other identifier
observational
635
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2022
CompletedFirst Submitted
Initial submission to the registry
August 21, 2022
CompletedFirst Posted
Study publicly available on registry
August 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 6, 2023
May 1, 2023
1.9 years
August 21, 2022
May 3, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
30 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
60 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
90 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
120 days
Proportion of positive PCR test for SARS-COV2
Percent Positive PCR test
150 days
Secondary Outcomes (13)
Proportion of symptomatic COVID 19 infection
30 days
Proportion of symptomatic COVID 19 infection
90 days
Proportion of symptomatic COVID 19 infection
182 days
Proportion of COVID 19 infection requiring hospitalization
30days
Proportion of COVID 19 infection requiring hospitalization
90 days
- +8 more secondary outcomes
Study Arms (2)
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
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soroka UMC
Beersheba, 84101, Israel
Biospecimen
* Blood drawn for PBMC and antibody testing: * Will be at ONLY at Soroka Medical Center. Subjects who were not part of the PBMC group and are willing to participate, will be asked again to sign inform consent. * Subjects participating in this part will have 30 ml (3 vials of 9 ml and 1 vial of 3 ml) of blood drawn for PBMC and antibody testing. Others will have blood draw of three 5 ml vials, for antibody testing. * A nasal and mouth swab will be performed.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Internal Department H
Study Record Dates
First Submitted
August 21, 2022
First Posted
August 25, 2022
Study Start
January 6, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
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.