Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers

Tuberculosis Clinical Trial

Official title: A Phase Ib/IIa Two-part, Randomized, Placebo-controlled, Observer-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in BCG Vaccinated, HIV-negative Subjects and People Living With HIV

Status Recruiting

Clinical Trial Summary

This two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study will be conducted in countries in Africa and Asia, including Republic of South Africa, Mozambique, and Republic of the Philippines. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. This study includes: Part A (Phase Ib) and Part B (Phase IIa).

Clinical Trial Description

In Part A, enrollment for BNT164a1 and BNT164b1 will be conducted independently and in parallel. Part A of the study will enroll participants into four dose groups per investigational medicinal product ([IMP] i.e., BNT164a1 or BNT164b1) who will be stratified by interferon gamma release assay (IGRA) status and then randomized 5:1 for BNT164 (BNT164a1 or BNT164b1):placebo. This part of the study will use a staggered dose escalation schema, i.e., enrollment into the next higher dose level is done sequentially and subject to safety data from the previous dose levels, with sentinel participants for Dose 1 in all dose groups. In Part B, up to two dose levels for each IMP will be selected for the human immunodeficiency virus (HIV)-negative dose groups based on the safety and immunogenicity data from Part A, as above. The higher of these two dose levels for each IMP will be used in the people living with HIV (PLWH) dose groups. Part B of this study is a safety expansion to up to two dose groups per IMP (BNT164a1 or BNT164b1) + placebo for HIV-negative participants. Additionally, Part B will include a population expansion into PLWH with up to one dose groups per IMP (BNT164a1 or BNT164b1) + placebo. HIV-negative participants will be randomized 3:3:3:3:1 to the four dose groups of BNT164 (BNT164a1 or BNT164b1):placebo. PLWH will be randomized 2:2:1 to the two dose groups of BNT164 (BNT164a1 or BNT164b1):placebo. In both Part A and Part B, participants will undergo a three-dose injection schedule with approximately 8 weeks between the first and second dose and approximately 16 weeks between the second and third dose. ;

Related Conditions & MeSH terms

• Tuberculosis

• NCT number: NCT05547464
• Study type: Interventional
• Source: BioNTech SE
• Contact: BioNTech clinical trials patient information
• Phone: +49 6131 9084
• Email: patients@biontech.de
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 31, 2023
• Completion date: February 2027