Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00707967
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
* A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to any study procedure.
* Subjects must be HIV-positive and must have:
* received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
* documented suppressed HIV-1 RNA levels following HAART-treatment.
* a protocol defined CD4+ T cell count at screening
* If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.
* Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
* No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
* No history of extrapulmonary TB.
* No history of chemotherapy for TB.
Exclusion Criteria:
* Any change in antiretroviral drug regimen within 12 weeks prior to screening.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
* History of previous administration of experimental Mycobacterium tuberculosis vaccines.
* History of previous exposure to experimental products containing components of the experimental vaccine.
* Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
* Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
* Planned participation or participation in another experimental protocol during the study period.
* A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
* Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
* History of allergic reactions or anaphylaxis to any vaccine.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.
* Pregnant female, lactating female or female planning to become pregnant or stop contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00707967
Study Brief:
Protocol Section:
NCT00707967