NCT06050356

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

A Phase 1a, Dose-finding, Open-label Trial Followed by a Phase 1b, Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Tuberculosis Subunit Vaccine H107e/CAF®10b in Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-09-22
• Last updated: 2026-03-10

Locations

1 site across 1 country: South Africa