A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults

Trial status:Study Complete
Trial ID:
BNT162-01
NCT ID:
NCT04380701
EudraCT ID:
2020-001038-36
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete

Trial Details

Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). The conducted Part A was a dose-finding part to investigate the optimal dose of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2), allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants and expansion cohorts were chosen based on acceptability of dosing in younger participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 were administered using a Prime/Boost (P/B) regimen with two doses given \~21 days apart. The vaccine BNT162c2 was also administered using a Single dose (SD) regimen. Four additional expansion cohorts (cohorts 11, 12, 13, and 14) aged from 18 to 85 years received BNT162b2 using a P/B regimen only. In cohort 11, participants received BNT162b2 using one 3 μg prime dose (Dose 1) and one 30 μg boost dose (Dose 2) of BNT162b2. Participants in cohorts 12, 13, and 14 received two doses of BNT162b2 30 µg, each.

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162a1
    • See more
  • BNT162b1
  • BNT162b2
  • BNT162c2
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    512
    Estimated Trial Date
    Apr 2020 - Jun 2021

    Trial Participant Requirements

    Age
    18 - 85 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    Contract Research Organization
    Berlin, Germany
    Status
    Location
    Universitäts Klinikum
    Frankfurt am Main, Germany
    Status
    Location
    Universitäts Klinikum
    Heidelberg, Germany
    Status
    Location
    Contract Research Organization
    Kiel, Germany
    Status
    Location
    Contract Research Organization
    Mannheim, Germany
    Status