First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b

Summary

Tuberculosis (TB) is an infection caused by bacteria passed from one person to another through the air when an infected person for instance coughs, speaks, or sneezes. This study tests the safety and vaccine-induced immune response of a new preventive TB vaccine called H107e/CAF®10b. H107e is a copy of protein parts from the bacterium causing tuberculosis, Mycobacterium tuberculosis, which are also called antigens. CAF®10b is an adjuvant which helps the body discover the antigen. The adjuvant and antigen are mixed together to formulate the final vaccine. The final formulated vaccine enhances the immune system's response against the antigen.

This is a first-in-human study, meaning this vaccine is being given to people for the first time. The primary objective is to evaluate the safety of the vaccine and its components; however, the study will also evaluate the specific immune responses generated by the new vaccine. The study is divided into two parts, phase 1a and phase 1b. Phase 1a investigates unadjuvanted H107e, CAF®10b adjuvant, H107e/CAF®10b vaccine (low adjuvant dose), and H107e/CAF®10b vaccine (full adjuvant dose). The trial products are administered twice intramuscularly. H107e is also administered intranasally in one of the groups on Day 85. Phase 1b investigates H107e/CAF®10b, H107e/CAF®10b+Bacillus Calmette-Guérin (BCG), BCG, and placebo. A placebo is a look-alike substance that contains no active drug. All groups in phase 1b receive H107e intranasally on Day 211.

A preventive TB vaccine such as H107e/CAF®10b should be able to introduce the body's immune system to antigens from Mycobacterium tuberculosis. This will result in memory in the immune system, meaning that when a person gets infected with Mycobacterium tuberculosis, the immune system will recognise and target the bacteria to prevent disease, thereby avoiding the need for antibiotic treatment and/or other treatments and their side effects.

Conditions

• Healthy

Interventions

BIOLOGICAL

H107e

Participants will receive two i.m. injections of 20 µg unadjuvanted H107e on Day 1 and Day 29

BIOLOGICAL

CAF®10b

Participants will receive two i.m. injections of CAF®10b (full adjuvant dose) on Day 1 and Day 29

BIOLOGICAL

H107e/CAF®10b - low adjuvant dose

Participants will receive two i.m. injections of 20 µg H107e/CAF®10b (low adjuvant dose) on Day 1 and Day 29

BIOLOGICAL

H107e/CAF®10b - full adjuvant dose

Participants will receive two i.m. injections of 20 µg H107e/CAF®10b (full adjuvant dose) on Day 1 and Day 29

BIOLOGICAL

Low dose intranasal H107e

Participants will receive one i.n. administration of 15 µg H107e (low dose intranasal H107e) on Day 85

BIOLOGICAL

Full dose intranasal H107e

Participants will receive one i.n. administration of 30 µg H107e (full dose intranasal H107e) on Day 85

BIOLOGICAL

H107e/CAF®10b

Participants will receive two i.m. injections of 20 µg H107e/CAF®10b (full adjuvant dose) on Day 1 and Day 29

BIOLOGICAL

i.m. placebo

Participants will receive two i.m. injections of placebo on Day 1 and Day 29

BIOLOGICAL

BCG

Participants will receive one i.d. injection of BCG on Day 1

BIOLOGICAL

i.d. placebo

Participants will receive one i.d. injection of placebo on Day 1

BIOLOGICAL

Intranasal H107e

Participants will receive one i.n. administration of 30 µg H107e (full dose intranasal H107e) on Day 211

Sponsors & Collaborators

• Aurum Institute

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• South African Tuberculosis Vaccine Initiative

  collaborator OTHER

• Statens Serum Institut

  lead OTHER

Principal Investigators

• Gavin Churchyard, PhD · Aurum Institute

• Rasmus Mortensen, PhD · Statens Serum Institut

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-14

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• South Africa

Study Locations