Clinical Trials Directory

Trials / Completed

CompletedNCT04380701

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
512 (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 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.

Detailed description

This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first-in-human (FIH) dose and dose ranging groups for all four vaccines in healthy younger participants (aged 18 to 55 years \[years\]) and older participants (aged 56 to 85 years). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the 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 and a follow-up phase. For the BNT162a1 3 µg arm, the Safety Review Committee (SRC) decided to stop dosing after 6 treated participants and to not administer the boost immunization (Dose 2). For the BNT162b1 60 µg arm, the SRC decided to not administer the boost immunization (Dose 2) for the 12 participants.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBNT162a1Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b1Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b2Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162c2Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.

Timeline

Start date
2020-04-23
Primary completion
2021-06-30
Completion
2022-04-13
First posted
2020-05-08
Last updated
2024-07-12
Results posted
2024-07-12

Locations

5 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT04380701. Inclusion in this directory is not an endorsement.