NCT05231005

Fourth BNT162b2 COVID-19 Vaccine Dose

Status unknown Phase 4 Last updated 27 December 2023

What this trial tests

Phase 4 trial testing BNT162b2 vaccine in COVID-19 Pandemic in 1,000 participants. Status unknown.

Timeline

27 December 2021

Primary endpoint
26 June 2024

26 June 2024

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,000
Start date	27 December 2021
Primary completion	26 June 2024
Estimated completion	26 June 2024
Sites	1 location across Israel

Drugs / interventions tested

• BNT162b2 vaccine — full drug profile →

Conditions studied

• COVID-19 Pandemic — all drugs for COVID-19 Pandemic →

Sponsor

Sheba Medical Center

Who can join

18 and older, any sex, with COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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the investigators now have preliminary, yet unpublished data, showing slow waning of the immune response after the third dose of the BNT162b2 mRNA vaccine within 4 months after this dose .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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron.
   Regev-Yochay G, Gonen T, Gilboa M, Mandelboim M, et al · · 2022 · cited 335× · PMID 35297591 · DOI 10.1056/nejmc2202542
2. Lipid nanoparticles for delivery of RNA therapeutics: Current status and the role of <i>in vivo</i> imaging.
   Jung HN, Lee SY, Lee S, Youn H, et al · · 2022 · cited 155× · PMID 36438494 · DOI 10.7150/thno.77259
3. OMICRON: Virology, immunopathogenesis, and laboratory diagnosis.
   Bazargan M, Elahi R, Esmaeilzadeh A. · · 2022 · cited 41× · PMID 35726542 · DOI 10.1002/jgm.3435
4. Immunogenicity and efficacy of fourth BNT162b2 and mRNA1273 COVID-19 vaccine doses; three months follow-up.
   Canetti M, Barda N, Gilboa M, Indenbaum V, et al · · 2022 · cited 23× · PMID 36513665 · DOI 10.1038/s41467-022-35480-2
5. 4th Dose COVID mRNA Vaccines’ Immunogenicity & Efficacy Against Omicron VOC
   Regev-Yochay G, Gonen T, Gilboa M, Mandelboim M, et al · · 2022 · cited 9× · DOI 10.1101/2022.02.15.22270948
6. Current clinical status of new COVID-19 vaccines and immunotherapy.
   Nagpal D, Nagpal S, Kaushik D, Kathuria H. · · 2022 · cited 6× · PMID 36063274 · DOI 10.1007/s11356-022-22661-1
7. Immune Response and Clinical Outcomes of BNT162b2 and mRNA1273 Fourth Dose COVID-19 Vaccines; Three Months Follow-up
   Canetti M, Barda N, Gilboa M, Indenbaum V, et al · · 2022 · DOI 10.21203/rs.3.rs-1946528/v1