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

NCT04380701 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2024-07-12

Study results available
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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.

Conditions

  • Infections, Respiratory
  • Virus Diseases
  • Infection Viral
  • Vaccine Adverse Reaction
  • RNA Virus Infections
  • Protection Against COVID-19 and Infections With SARS CoV 2

Interventions

BIOLOGICAL

BNT162a1

Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.

BIOLOGICAL

BNT162b1

Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.

BIOLOGICAL

BNT162b2

Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.

BIOLOGICAL

BNT162c2

Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2021-06-30
Completion
2022-04-13

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380701 on ClinicalTrials.gov