Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

Summary

This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.

Timeline

Start

2021-08-25

Primary completion

2023-08-16

Completion

2023-10-04

Publications

• Muik A, Quandt J, Lui BG, Bacher M, Lutz S, Grunenthal M, Toker A, Grosser J, Ozhelvaci O, Blokhina O, Shpyro S, Vogler I, Salisch N, Tureci O, Sahin U. Immunity against conserved epitopes dominates after two consecutive exposures to SARS-CoV-2 Omicron BA.1. Cell Rep. 2024 Aug 27;43(8):114567. doi: 10.1016/j.celrep.2024.114567. Epub 2024 Aug 3.
• Muik A, Lui BG, Quandt J, Diao H, Fu Y, Bacher M, Gordon J, Toker A, Grosser J, Ozhelvaci O, Grikscheit K, Hoehl S, Kohmer N, Lustig Y, Regev-Yochay G, Ciesek S, Beguir K, Poran A, Vogler I, Tureci O, Sahin U. Progressive loss of conserved spike protein neutralizing antibody sites in Omicron sublineages is balanced by preserved T cell immunity. Cell Rep. 2023 Aug 29;42(8):112888. doi: 10.1016/j.celrep.2023.112888. Epub 2023 Jul 31.
• Muik A, Lui BG, Bacher M, Wallisch AK, Toker A, Couto CIC, Guler A, Mampilli V, Schmitt GJ, Mottl J, Ziegenhals T, Fesser S, Reinholz J, Wernig F, Schraut KG, Hefesha H, Cai H, Yang Q, Walzer KC, Grosser J, Strauss S, Finlayson A, Kruger K, Ozhelvaci O, Grikscheit K, Kohmer N, Ciesek S, Swanson KA, Vogel AB, Tureci O, Sahin U. Exposure to BA.4/5 S protein drives neutralization of Omicron BA.1, BA.2, BA.2.12.1, and BA.4/5 in vaccine-experienced humans and mice. Sci Immunol. 2022 Dec 23;7(78):eade9888. doi: 10.1126/sciimmunol.ade9888. Epub 2022 Dec 23.

Drugs

Indications