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

Active, not recruiting

• Conditions: Coronavirus Infections
• Interventions: Biological: Pfizer BNT162b2 Vaccine

• Registration Number: NCT05516459
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 635

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Four doses of vaccination	Pfizer BNT162b2 Vaccine	Subjects received three pfizer BNT162b2 vaccination at least four month before recruitment and decided to receive another dose at time of recruitment or followup

Primary Outcome Measures

Name	Time	Method
Proportion of positive PCR test for SARS-COV2	150 days	Percent Positive PCR test

Secondary Outcome Measures

Name	Time	Method
Proportion of COVID 19 infection requiring hospitalization	182 days	Percent Positive PCR test
Composite endpoint of serious adverse events	14 days following the booster vaccination	Percent Positive Anaphylaxis, Myocarditis
Proportion of symptomatic COVID 19 infection	182 days	Percent Positive PCR test
Levels of binding and neutralizing activity and avidity of the antibodies	180 days	50 Percent neutralization titer

Trial Locations

Locations (1)

Soroka UMC; 🇮🇱 Beer- Sheva, Israel