Fourth BNT162b2 COVID-19 Vaccine Dose

NCT05231005 | Unknown Phase 4 DMC

• 1 other identifier: 8980-21
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Omicron variant of concern (VOC) is currently rapidly spreading worldwide, with extremely high transmission rates, with an estimated R of \>3. the investigators now have preliminary, yet unpublished data, showing slow waning of the immune response after the third dose of the BNT162b2 mRNA vaccine within 4 months after this dose . While these data would not have been worrisome in the Delta VOC era, this may be different with the emergence of the Omicron VOC. These data raise the question of when and will a 4th dose be needed to cope with the emergence of Omicron. However, if a have reached the maximal effect of the current vaccine has been reached against Omicron, with a third dose, will a 4th dose have any added value? Here, the investigators will study the potential immunogenicity of a 4th dose, together with assessing safety and effectiveness in preventing infections

Conditions

COVID-19 Pandemic

Keywords

COVID-19; BNT162b2 vaccine; Omicron; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Geometric mean of antibody titers of each arm, on each time point

  Serology tests including IgG, neutralization, Tcell activity . These will be compared between pre- and post- 4th dose as well as with those outcomes in the control group. Adverse event reporting of vaccinated individuals by an electronic survey that will be filled from visit 2. Serious adverse events will be defined as any adverse event that resulted in death, hospitalization, permanent damage, required treatment in the emergency room or was life threatening.

  6 months

• Solicited and unsolicited adverse events

  Solicited adverse event, including local and systemic as reported in questionnaires and telephone calls on days 5, 7., 14, and 21. Unsolicited AE during the whole study period

  6 months

Secondary Outcomes (1)

• Cumulative incidents of infections in each arm

  6 months

Study Arms (2)

4th dose BNT162b2 vaccine

EXPERIMENTAL

The investigators will recruit 150-200 volunteers, who received the 3rd dose at least 4 months previously, and have a known serology history (showing an immune response (even if just a low response) to the three previous doses, but with a recent relatively low IgG (below 700 BAU). These volunteers will recieve a 4th dose (30 microgram) of the BNT162b2 vaccine

Biological: BNT162b2 vaccine

Control

NO INTERVENTION

As controls, a sub-cohort of similar HCW, who are recruited to the Sheba COVID Cohort study (IRB 8008-20) and are followed monthly with serology tests, and are not receiving the 4th dose. The control group, all of whom signed an informed consent and allowed blood samples to be used for further immunologic studies, will be matched by age, gender, time from 3rd vaccine dose and IgG titers, and will be followed similarly

Interventions

BNT162b2 vaccine BIOLOGICAL

fourth dose of the BNT162b2 vaccine (30 microgram) adminstered IM

4th dose BNT162b2 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Volunteer must be at least 18 years of age, at the time of signing the informed conset.
• Sex: Male or Female. All female volunteers of reproductive age will be requested to use contraceptive measures for the two months following enrolment.
• Received 3 doses of BNT162b2 with the 3rd dose at least 4 months previously.
• Have a serology test within the previous 3 months of 700 BAU or less.
• Responded to the previous vaccine doses, i.e. at least one IgG\>100.
• Medical Conditions: Volunteers with any medical condition are allowed, as long as they adhere to the criteria above.
• Agreed to attend all visits and signed the informed consent -

You may not qualify if:

• \- 1. Had previous SARS-CoV-2 infection (detected by either PCR, anti-S IgG before the 1st vaccine dose, anti-N IgG at any stage).
• \. Had an allergic response to any of the previous BNT162b2 doses. 3. Has history of myopericarditis. 4. Report that they do not feel well or have a fever on the day of vaccination. 5. Pregnant on day of recruitment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Related Publications (1)

• Canetti M, Barda N, Gilboa M, Indenbaum V, Mandelboim M, Gonen T, Asraf K, Weiss-Ottolenghi Y, Amit S, Doolman R, Mendelson E, Harats D, Freedman LS, Kreiss Y, Lustig Y, Regev-Yochay G. Immunogenicity and efficacy of fourth BNT162b2 and mRNA1273 COVID-19 vaccine doses; three months follow-up. Nat Commun. 2022 Dec 13;13(1):7711. doi: 10.1038/s41467-022-35480-2.

  PMID: 36513665 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Gili Regev-Yochay, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infection Prevention & Control Unit

Model Details: This is a prospective intervention study, to test the effect of a 4th dose, by comparing the immune response before and after the 4th dose, given to 150-200 volunteers, as well as comparing their responses with a control group of individuals vaccinated with 3 doses but without the 4th

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 9, 2022
• Study Start: December 27, 2021
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: will be available upon publication of results.
• Access Criteria: upon request

Locations

IL (1)