Testing a new tuberculosis vaccine in healthy adults

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

This study is testing a new tuberculosis vaccine in healthy adults to see how safe it is and how well it boosts their immune response.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Statens Serum Institut (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Pretoria, Gauteng)
• Trial ID: NCT06050356 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immune response of a novel tuberculosis vaccine candidate called H107e/CAF®10b in healthy adults. The vaccine combines protein parts from the Mycobacterium tuberculosis bacterium with an adjuvant to enhance the immune response. As a first-in-human trial, it aims to assess how well the vaccine is tolerated and the specific immune responses it generates. The study is divided into two parts, focusing on different dosages of the vaccine.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 who are HIV-negative and meet specific laboratory criteria.

Not a fit: Patients with existing health conditions or those who are HIV-positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new preventive measure against tuberculosis, potentially reducing the incidence of the disease.

How similar studies have performed: Other studies have shown promise with similar vaccine approaches, but this specific candidate is novel and untested in humans.

Eligibility criteria

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 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

Exclusion Criteria:

* 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
* 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

Where this trial is running

Pretoria, Gauteng

• Aurum Institute — Pretoria, Gauteng, South Africa (Recruiting)

Study contacts

• Study coordinator: Pernille Tingskov

Conditions Healthy; Prophylactic tuberculosis vaccine; First-in-human; Subunit vaccine; Adjuvant; BCG; Tuberculosis