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

PHASE1RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

March 14, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

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

Trial Locations (1)

0028

RECRUITING

Aurum Institute, Pretoria

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aurum Institute

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

South African Tuberculosis Vaccine Initiative

OTHER

lead

Statens Serum Institut

OTHER