NCT05004181

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

A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,380 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

Trial participants in Part A were assigned to one of 6 cohorts (Cohort 1-6). Trial participants in Part B were assigned to one of 3 cohorts (Cohort 1, 4, and 6). Trial participants in Part C were randomized in a 2:2:1 ratio into 3 cohorts (Cohort 7-9).

Conditions

• SARS-CoV-2 Infection
• COVID-19
• SARS-CoV-2 Acute Respiratory Disease
• SARS (Disease)

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular (IM)
BIOLOGICAL	Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)	Intramuscular (IM)
BIOLOGICAL	Monovalent BNT162b2 (B.1.1.7)	Intramuscular (IM)
BIOLOGICAL	Monovalent BNT162b2 (B.1.617.2)	Intramuscular (IM)
BIOLOGICAL	Monovalent BNT162b2 (B.1.1.529.1)	Intramuscular (IM)
OTHER	Observational	No vaccination within 3 months after Visit 1.

Timeline

• Start date: 2021-08-25
• Primary completion: 2023-08-16
• Completion: 2023-10-04
• First posted: 2021-08-13
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

35 sites across 4 countries: United States, Germany, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study