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ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039) (TB039)

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ClinicalTrials.gov Identifier: NCT04121494
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
François Spertini, Centre Hospitalier Universitaire Vaudois

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mycobacterium Tuberculosis, Protection Against Tuberculosis Biological: ChadOx1 85A - aerosol Biological: ChadOx1 85A - IM Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stage I - dose escalation study (Arms A,B,C) Stage II - experimental arms: randomized (Arms D,E), parallel (Arm F)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking for Arms D,E Non-masking for Arms A,B,C,F
Primary Purpose: Prevention
Official 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
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Group A
BCG-vaccinated, 1x10^9 vp, aerosol
Biological: ChadOx1 85A - aerosol
Aerosol administration through the Omron MicroAIR NE-U22 nebuliser

Experimental: Group B
BCG-vaccinated, 5x10^9 vp, aerosol
Biological: ChadOx1 85A - aerosol
Aerosol administration through the Omron MicroAIR NE-U22 nebuliser

Experimental: Group C
BCG-vaccinated, 1x10^10 vp, aerosol
Biological: ChadOx1 85A - aerosol
Aerosol administration through the Omron MicroAIR NE-U22 nebuliser

Experimental: Group D
BCG-vaccinated, highest tolerated dose aerosol + placebo IM; Randomized with Group E, blind
Biological: ChadOx1 85A - aerosol
Aerosol administration through the Omron MicroAIR NE-U22 nebuliser

Experimental: Group E
BCG-vaccinated, highest tolerated dose IM + placebo aerosol; Randomized with Group D, blind
Biological: ChadOx1 85A - IM
Intramuscular administration

Experimental: Group F
BCG-non vaccinated, highest tolerated dose, aerosol
Biological: ChadOx1 85A - aerosol
Aerosol administration through the Omron MicroAIR NE-U22 nebuliser




Primary Outcome Measures :
  1. Safety - (serious) adverse events [ Time Frame: Day 0 to Day 168 ]
    Frequency, incidence and nature of Adverse Events (AE) and Serious Adverse Events (SAE)


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Day 0 to 168 ]
    Characterization of cell mediated and humoral immune markers in response to vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121494


Contacts
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Contact: François Spertini, MD +41 21 314 07 99 francois.spertini@chuv.ch
Contact: Aurélie Mello, PhD +41 21 314 32 93 aurelie.mello@chuv.ch

Locations
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Switzerland
Centre hospitalier universitaire vaudois Recruiting
Lausanne, Switzerland, 1011
Contact: François Spertini, MD    +41 21 314 07 99    francois.spertini@chuv.ch   
Contact: Olfa Karoui, MD    +41 79 556 11 57    olfa.karoui@chuv.ch   
Principal Investigator: François Spertini, MD         
Sub-Investigator: Olfa Karoui, MD         
Sub-Investigator: Alban Lovis, MD         
Sub-Investigator: Helen McShane, MD         
Sponsors and Collaborators
François Spertini
University of Oxford

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Responsible Party: François Spertini, médecin-chef, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04121494     History of Changes
Other Study ID Numbers: CHADOX
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: availability of study protocol
Supporting Materials: Study Protocol
Time Frame: immediately without limit in time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by François Spertini, Centre Hospitalier Universitaire Vaudois:
ChAdOx1 85A
Tuberculosis
vaccination
BCG
Mucosal
Inhaled vaccine
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs