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HealthyPhase 1nTB-01NCT06050356

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

A Phase 1 study testing H107e, CAF®10b and H107e/CAF®10b - low adjuvant dose in people with Healthy, run by Statens Serum Institut at 1 site in South Africa.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
H107e, CAF®10b and H107e/CAF®10b - low adjuvant dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteSouth Africa
Study dates
14 Mar 2024to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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 child-bearing potential if she is surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). Written evidence of surgical sterility would be optimal
  • Agrees to give access to medical records for trial related purposes
  • Agrees to stay in contact with the trial site for the duration of the trial, provide updated contact information as necessary and has no current plans to move from the area for the duration of the trial

Who cannot join

  • Previous diagnosis or current diagnosis of TB, including suspected subclinical TB
  • Reported current household contact with TB. Note: Daily caregivers to TB infected persons will be considered as household contacts
  • History of or ongoing severe disease that in the opinion of the investigator might affect the safety of the participant or the immunogenicity of the trial product
  • Insulin-dependent diabetes
  • History of allergic disease or reactions likely to be exacerbated by any component of the trial product
  • History of chronic allergic rhinitis likely to interfere with the assessment of the mucosal recall
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  • History of frequent or severe epistaxis
  • History or laboratory evidence of primary and/or acquired immunodeficiency, autoimmune disease, or immunosuppression
  • History of a malignant condition (e.g. lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticuloendothelial system)
  • History of chronic hepatitis
  • Has a body mass index ≤18 or ≥35 at screening (weight [kg] / (height [m] * height [m]))
  • Abnormal chest X-ray at screening
  • Receipt or planned receipt of any other investigational TB vaccine
  • Receipt or planned receipt of any other investigational drug
  • Receipt of emergency use authorised/emergency use listed [EUA/EUL] vaccines or licensed live attenuated vaccines (e.g., measles, mumps, and rubella [MMR], oral polio vaccine [OPV], varicella, yellow fever, live attenuated influenza vaccine, live attenuated COVID-19 vaccine) within 30 days prior to screening
  • Receipt of any EUA/EUL or licensed vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, Hepatitis A or B, not live attenuated COVID-19 vaccine) within 14 days prior to screening
  • Receipt of anticoagulant therapy, including daily acetylsalicylic acid product. NOTE: Intermittent symptomatic use is permitted
  • Receipt of treatment likely to modify the immune response (e.g. blood products, immunoglobulins) within 42 days before screening
  • Receipt of immunosuppressive medications, including radiotherapy, nasal corticosteroids and inhaled corticosteroids. NOTE: Use of the following is permitted:
  • Topical corticosteroids for mild, uncomplicated dermatologic conditions except if administered on the site of injection of trial products
  • A single course of oral/parenteral prednisone or equivalent at doses <60 mg/day and for <11 days with completion at least 30 days prior to screening
  • Female participants: if lactating/nursing, or pregnant as per positive pregnancy test
  • Not suitable for inclusion in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Aurum Institute

    Pretoria, Gauteng, 0028

Other trials in South Africa

About this study

Official title: 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

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
Being tested
H107e, CAF®10b, H107e/CAF®10b - low adjuvant dose, H107e/CAF®10b - full adjuvant dose, Low dose intranasal H107e
Keywords
Prophylactic tuberculosis vaccine, First-in-human, Subunit vaccine, Adjuvant, BCG, Tuberculosis
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H107eBiological

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

  • CAF®10bBiological

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

  • H107e/CAF®10b - low adjuvant doseBiological

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

  • H107e/CAF®10b - full adjuvant doseBiological

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

  • Low dose intranasal H107eBiological

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

  • Full dose intranasal H107eBiological

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

  • H107e/CAF®10bBiological

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

  • i.m. placeboBiological

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

  • BCGBiological

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

  • i.d. placeboBiological

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

  • Intranasal H107eBiological

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

Study groups in NCT06050356
Study groupRoleWhat they receive
Arm 1 (phase 1a)ExperimentalH107e
Receives: Biological: H107e
Arm 2 (phase 1a)ExperimentalCAF®10b
Receives: Biological: CAF®10b
Arm 3 (phase 1a)ExperimentalH107e/CAF®10b - low adjuvant dose
Receives: Biological: H107e/CAF®10b - low adjuvant dose
Arm 4a (phase 1a)ExperimentalH107e/CAF®10b - full adjuvant dose - low dose intranasal H107e
Receives: Biological: H107e/CAF®10b - full adjuvant dose; Biological: Low dose intranasal H107e
Arm 4b (phase 1a)ExperimentalH107e/CAF®10b - full adjuvant dose - full dose intranasal H107e
Receives: Biological: H107e/CAF®10b - full adjuvant dose; Biological: Full dose intranasal H107e
Arm 1 (phase 1b)ExperimentalH107e/CAF®10b
Receives: Biological: H107e/CAF®10b; Biological: i.d. placebo; Biological: Intranasal H107e
Arm 2 (phase 1b)ExperimentalH107e/CAF®10b + BCG
Receives: Biological: H107e/CAF®10b; Biological: BCG; Biological: Intranasal H107e
Arm 3 (phase 1b)Active comparatorBCG
Receives: Biological: i.m. placebo; Biological: BCG; Biological: Intranasal H107e
Arm 4 (phase 1b)Placebo comparatorPlacebo
Receives: Biological: i.m. placebo; Biological: i.d. placebo; Biological: Intranasal H107e

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

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

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

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

    Adverse events of special interest represent a subset of AEs that include autoimmune diseases and other systemic disorders of interest which could potentially have an autoimmune etiology

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

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

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

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

    This outcome is only measured for phase 1a Arm 4a and Arm 4b. Solicited adverse events related to mucosal recall consist of local and systemic reactions

    Measured: Day 85 up to Day 92 (7 days after mucosal recall)

  7. Percentage of participants with unsolicited adverse events occurring up to 28 days after i.n. mucosal recall (phase 1a)

    This outcome is only measured for phase 1a Arm 4a and Arm 4b

    Measured: Day 85 up to Day 113 (28 days after mucosal recall)

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

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

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

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

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

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

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

    Adverse events of special interest represent a subset of AEs that include autoimmune diseases and other systemic disorders of interest which could potentially have an autoimmune etiology

    Measured: Up to Day 281 (280 days after first dose)

  12. Percentage of participants with SAEs occurring up to last visit (phase 1b)

    Measured: Up to Day 281 (280 days after first dose)

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

    Solicited adverse events related to mucosal recall consist of local and systemic reactions

    Measured: Day 211 up to Day 218 (7 days after mucosal recall)

  14. Percentage of participants with unsolicited adverse events occurring up to 28 days after i.n. mucosal recall (phase 1b)

    Measured: Day 211 up to Day 239 (28 days after mucosal recall)

  15. Frequencies of H107e-specific CD4+ T-cells producing any combination of Th1 cytokines (IFN-γ, TNF, and/or IL-2) induced by H107e/CAF®10b vs. placebo and vs. H107e/CAF®10b + BCG before vaccination (Day 1) and 2 weeks after 2nd vaccination (phase 1b)

    Whole blood ICS is used to evaluate this outcome

    Measured: Day 1 and Day 43

Secondary outcomes (2)

  1. Frequencies of H107e-specific IFN-γ producing T-cells before first i.m. vaccination and two weeks after the second i.m. vaccination (phase 1a)

    ELISpot assay on PBMCs is used to evaluate this outcome

    Measured: Day 1 and Day 43

  2. Frequencies of BCG-specific CD4+ T-cells producing any combination of Th1 cytokines (i.e., IFN-γ, TNF and/or IL-2) induced by H107e/CAF®10b + BCG vs. BCG alone (Day 1 and 43) (phase 1b)

    Whole blood ICS is used to evaluate this outcome

    Measured: Day 1 and Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start14 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1a proceeds as sequential dosing to determine early safety signals (Arms 1, 2, 3, 4a, and 4b). Phase 1b proceeds as parallel assignment. Participants are randomised to one of four treatment arms (H107e/CAF®10b; H107e/CAF®10b + BCG; BCG; placebo).
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050356
Sponsor's protocol ID
nTB-01
Other IDs
INV-042397, DOH-27-102023-7355
Acronym
nTB-01
Status last verified
Mar 2026
First submitted
17 Sep 2023
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing H107e, CAF®10b and H107e/CAF®10b - low adjuvant dose in people with Healthy, run by Statens Serum Institut at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with solicited injection site reactions recorded up to seven days after each i.m. vaccination (phase 1a) (time frame: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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