Active — Not RecruitingPhase 1

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

South Africa140 participantsStarted 2024-03-14

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adults aged ≥18 years and ≤ 45 years of age on the day of the screening visit * Completed the written informed consent process * Confirmed HIV-negative at screening * Confirmed Xpert MTB/RIF Ultra-negative at screening * Laboratory values within the indicated ranges obtained at screening: * Absolute neutrophil count (ANC) ≥800 cells/mm3 * Haemoglobin ≥ 11 g/dL for females and \>10.5 g/dL for males * Platelet count ≥ 100,000/mm3 * Serum creatinine ≤ 1.5 X upper limit of normal (ULN) * AST (SGOT), ALT (SGPT), and alkaline phosphatase, ≤ 2.5 X ULN * Total bilirubin ≤ 2 X ULN) * Agrees to refrain from blood donation during the course of the trial * Women of child-bearing potential must use a highly effective form of birth control (confirmed by the investigator) throughout the trial * A highly effective method of birth control is defined as hormonal contraceptives (oral, injection, transdermal patch, or implant), bilateral tubal occlusion or intrauterine device. The participants must have used the contraceptive method continuously for at least 21 days prior to the pregnancy test at baseline (Day 1) * A female is defined as not being of child-bearing potential if she is postmenopausal (aged 50 and above with at least 12 months with no menses without an alternative medical cause prior to screening. If less than 50 years old, then confirmatory Follicular stimulating hormone testing is required) * A female is defined as not being of c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants with solicited injection site reactions recorded up to seven days after each i.m. vaccination (phase 1a)

Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)

Percentage of participants with solicited systemic reactions recorded up to seven days after each i.m. vaccination (phase 1a)

Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)

Percentage of participants with unsolicited adverse events occurring up to 28 days after last i.m. vaccination (phase 1a)

Timeframe: Up to Day 57 (28 days after second dose)

Percentage of participants with adverse events of special interest occurring up to last visit (phase 1a)

Timeframe: Up to Day 197 (196 days after first dose)

Percentage of participants with serious adverse events (SAEs) occurring up to last visit (phase 1a)

Timeframe: Up to Day 197 (196 days after first dose)

Percentage of participants with solicited adverse events occurring up to seven days after i.n. mucosal recall (phase 1a)

Trial details

NCT IDNCT06050356

SponsorStatens Serum Institut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of participants with solicited injection site reactions recorded up to seven days after each i.m. vaccination (phase 1a)

Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)

Percentage of participants with solicited systemic reactions recorded up to seven days after each i.m. vaccination (phase 1a)

Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)

Percentage of participants with unsolicited adverse events occurring up to 28 days after last i.m. vaccination (phase 1a)

Timeframe: Up to Day 57 (28 days after second dose)

Percentage of participants with adverse events of special interest occurring up to last visit (phase 1a)

Timeframe: Up to Day 197 (196 days after first dose)

Percentage of participants with serious adverse events (SAEs) occurring up to last visit (phase 1a)

Timeframe: Up to Day 197 (196 days after first dose)

Percentage of participants with solicited adverse events occurring up to seven days after i.n. mucosal recall (phase 1a)