Prospective Monitoring of BNT162b2 Second Vaccination Booster Effects in Health Care Workers (HCW)

NCT ID: NCT05516459

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 635 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2023-12-31

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.

Conditions

Coronavirus Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Three doses of vaccination

Subjects received three pfizer BNT162b2 vaccination at least four month before recruitment

No interventions assigned to this group

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

Pfizer BNT162b2 Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

Pfizer BNT162b2 Vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Able to provide written informed consent.

2. Healthcare worker in one of the Clalit Health Services Medical centers and is at least 18 years of age.

3. Completed three doses of BNT162b2 according to MOH guidelines.

4. Third dose was given at least 4 months prior to enrollment.

Exclusion Criteria

1. History of COVID-19 infection.

2. 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.

3. 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).

4. Received in the past 4 months monoclonal antibodies of any type.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ben-Gurion University of the Negev

OTHER

Sponsor Role: collaborator

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Victor Novack

Head of Internal Department H

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Soroka UMC

Beersheba, , Israel

Countries

Israel

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

SCRC22001

Identifier Type: -

Identifier Source: org_study_id