Tuberculosis Clinical Trial
— TB039Official title:
A Phase I Clinical Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine ChAdOx1 85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Subjects
Verified date | September 2020 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a dose escalating and a paired-placebo design study to describe the safety and
immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled
vaccination versus intramuscular (IM) vaccination in adult healthy volunteers.
It is postulated that the aerosol inhaled route is practical and feasible and has an
acceptable safety profile, comparable to the systemic safety profile of the IM route of
administration of ChAdOx1 85A in adult healthy volunteers, and that the aerosol inhaled route
of administration will induce greater mucosal immunity and comparable systemic immunity when
compared to the IM (systemic) route of administration in these volunteers.
Volunteers are followed on a regular basis for safety and immunogenicity, with blood analysis
for biological safety tests and immune tests.
Status | Completed |
Enrollment | 39 |
Est. completion date | August 24, 2020 |
Est. primary completion date | August 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy adult aged 18-55 years. - Give informed consent as documented by signature. - Screening Interferon-Gamma release assay (IGRA) negative. - Chest radiograph normal. - Prior vaccination with BCG (except Group F). - No relevant findings in medical history or on physical examination. - Allow the Investigators to discuss the individual's medical history with their GP, if appropriate. - Use effective double contraception for the duration of the trial period (females and males). - Refrain from blood donation during the trial. - Able and willing (in the Investigator's opinion) to comply with all the trial requirements. Exclusion Criteria: - Previously resident for more than 12 consecutive months in a highly endemic area (tropical) where significant TB and non-tuberculous mycobacterial exposure is likely. - Participation in another research trial involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period. - Participation in a clinical trial involving vaccination with an adenovirus vector (such as Ebola or HIV trials) - Prior vaccination with any candidate TB vaccine. - Vaccination with any live, attenuated vaccine within 28 days prior to enrolment. - Vaccination with any subunit or killed vaccine within 14 days prior to enrolment (influenza vaccination is encouraged prior to participation). - Prior vaccination with BCG (Group F only). - Administration of immunoglobulins and/or any blood products within the three months preceding the enrolment. - Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except basal cell carcinoma or carcinoma in situ), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse. - Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents. - History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial agent, sedative drugs, or any local or general anaesthetic agents. - Pregnancy, lactation or intention to become pregnant during trial period. - Any respiratory disease, including perennial asthma, non-controlled seasonal allergic asthma - Smoking more than 3 cigarettes/day. - Clinically significant abnormality on screening chest radiograph. - Clinically significant abnormality of spirometry. - Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy. - Current use of any medication taken through the inhaled route. - Clinical, radiological, or laboratory evidence of current active TB disease. - Past treatment for TB disease. - Any clinically significant abnormality of screening blood or urine tests. - Positive HBsAg, HCV or HIV antibodies. - Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the trial or impair interpretation of the trial data. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre hospitalier universitaire vaudois | Lausanne |
Lead Sponsor | Collaborator |
---|---|
François Spertini | University of Oxford |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety - (serious) adverse events | Frequency, incidence and nature of Adverse Events (AE) and Serious Adverse Events (SAE) | Day 0 to Day 168 | |
Secondary | Immunogenicity | Characterization of cell mediated and humoral immune markers in response to vaccine | Day 0 to 168 |
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