BNT164b1 / BioNTech, Bill & Melinda Gates Foundation - LARVOL DELTA

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1/2 | N=492 | Recruiting | Sponsor: BioNTech SE | N=732 ➔ 492

Enrollment change • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1/2 | N=732 | Recruiting | Sponsor: BioNTech SE | Active, not recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: BioNTech SE | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Sep 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1/2 | N=732 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1/2 | N=732 | Recruiting | Sponsor: BioNTech SE | Phase classification: P1 ➔ P1/2 | N=144 ➔ 732 | Trial completion date: Sep 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Mar 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=128 | Recruiting | Sponsor: BioNTech SE | N=96 ➔ 128

Enrollment change • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: BioNTech SE

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: BioNTech SE

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: BioNTech SE | Trial completion date: Feb 2026 ➔ Oct 2025 | Trial primary completion date: Aug 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2024 ➔ Aug 2025

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: BioNTech SE | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: BioNTech SE | Initiation date: Apr 2023 ➔ Jul 2023

Trial initiation date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: BioNTech SE

New P1 trial • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: BioNTech SE

New P1 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis