MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection

University of Oxford

Status and phase: Terminated; Phase 1

Conditions: Tuberculosis

Treatments: Biological: Intramuscular MVA85A; Biological: Intramuscular Saline placebo; Biological: Aerosol inhaled Saline placebo; Biological: Aerosol inhaled MVA85A

Study type: Interventional

Funder types: Other

Identifiers

NCT02532036

TB040

Details and patient eligibility

About

TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.

Enrollment: 2 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Volunteers must meet all of the following criteria to enter the trial:

• Healthy adult aged 18-55 years
• Resident in or near Oxford, Birmingham or London for the duration of the trial period
• Screening IGRA positive
• Ineligible for chemoprophylaxis for latent M.tb infection, declined prophylaxis or considered low risk due to distant contact history
• Chest Computed Tomography (CT) normal; or abnormal with features consistent with primary M.tb infection but no features suggestive of active disease
• No relevant findings in medical history or on physical examination
• Allow the Investigators to discuss the individual's medical history with their General Practitioner
• Use effective contraception for the duration of the trial period (females only)
• Refrain from blood donation during the trial
• Give written informed consent
• Allow the Investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical trials
• Able and willing (in the Investigator's opinion) to comply with all the trial requirements

Exclusion criteria

Volunteers must meet none of the following criteria to enter the trial:

• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period
• Prior vaccination with candidate vaccine MVA85A, candidate vaccine FP85A,any other recombinant MVA vaccine or any other candidate TB vaccine
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
• Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), 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 vaccine, sedative drugs, or any local or general anaesthetic agents
• Pregnancy, lactation or intention to become pregnant during trial period
• Any respiratory disease, including asthma
• Current smoker
• Clinically significant abnormality on screening CT thorax
• Clinically significant abnormality of pulmonary function tests
• Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
• Current use of any medication taken through the nasal or inhaled route including cocaine or other recreational drugs
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2 participants in 3 patient groups

Starter Group

Experimental group

Description:

Receive 1x10^7 pfu aerosol inhaled MVA85A at day 0.

Treatment:

Biological: Aerosol inhaled MVA85A

Group A

Experimental group

Description:

Receive 5x10^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.

Treatment:

Biological: Aerosol inhaled MVA85A

Biological: Intramuscular Saline placebo

Group B

Experimental group

Description:

Receive 5x10^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.

Treatment:

Biological: Aerosol inhaled Saline placebo

Biological: Intramuscular MVA85A