Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00600782
• Date of registration: 15/01/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region
• Scientific title: Immunogenicity and Safety of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342) When Administered to Healthy Adults Aged 21 to 40 Years.
• Date of first enrolment: February 5, 2008
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00600782
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

South Africa

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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, 21 and 40 years of age at the time of the
first vaccination.

- Written informed consent obtained from the subject prior to any study procedure.

- Free of obvious health problems as established by medical history and clinical
examination before enrolment into the study.

- If the subject is female, she must be of non-childbearing potential, or if she is of
childbearing potential, 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 the vaccination series.

- No evidence of pulmonary pathology as confirmed by chest X-ray.

- Clinically normal laboratory values for creatinine, ALT, AST and complete blood count.

- Seronegative for human immunodeficiency virus-1 (HIV-1).

- No history of extrapulmonary TB.

- Subjects must have the appropriate PPD skin reactivity (induration measured at 48 to
72 hours after PPD skin test administration).

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of vaccine, or planned use
during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within 6
months prior to the first vaccine dose.

- History of previous administration of experimental Mycobacterium tuberculosis
vaccines.

- History of previous exposure to experimental products containing MPL or QS21.

- 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.

- Participation in another experimental protocol during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- A family history of congenital or hereditary immunodeficiency. Subjects who describe a
first-degree relative with clearly documented autoimmune disease will be excluded

- History of any acute or chronic illness or medication that, in the opinion of the
Investigator, may interfere with the evaluation of the safety or immunogenicity of the
vaccine.

- Any chronic drug therapy to be continued during the study period, with the exception
of vitamins and/or dietary supplements, birth control pills, anti-histamines for
seasonal allergies, SSRIs.

- History of any neurologic disorders or seizures.

- History of allergic reactions or anaphylaxis to previous immunisations.

- 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 investigators
opinion would put the subject at risk.

- Major congenital defects.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.



Age minimum: 21 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis (TB)

Tuberculosis Vaccines

Intervention(s)

Biological: GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)

Primary Outcome(s)

Occurrence, intensity and relationship to vaccination of unsolicited symptoms [Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose]

Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose]

Haematological and biochemical levels [Time Frame: At protocol defined time points]

Occurrence and relationship to vaccination of serious adverse events [Time Frame: During the entire study period]

Secondary Outcome(s)

Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry [Time Frame: At protocol defined time points]

Antibody titres to M72 measured by ELISA [Time Frame: At protocol defined time points]

Secondary ID(s)

110347

Source(s) of Monetary Support

Please refer to primary and secondary sponsors