NCT04537949

A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults

A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.

Detailed description

This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first in human dose and dose ranging groups in healthy younger participants (aged 18 to 55 years \[yrs\]) and older participants (aged 56 to 85 yrs). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the first-in-human \[FIH\] immunization and any subsequent dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses lower than previously tested, participants were dosed using a subject staggering process. Cohorts in older participants were optional and dependent on acceptability of dosing in younger participants. Part A consisted of a treatment phase (screening to Visit 7) and a follow-up phase (Visits 8 to 10).

Conditions

• Covid-19
• Protection Against COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b3	Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-03-12
• Completion: 2022-02-07
• First posted: 2020-09-03
• Last updated: 2024-01-05
• Results posted: 2022-03-24

Locations

2 sites across 1 country: Germany