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

NCT00600782 | Completed Phase 2

• 1 other identifier: 110347
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Tuberculosis (TB); Tuberculosis Vaccines

Keywords

Tuberculosis vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence, intensity and relationship to vaccination of solicited local and general symptoms

  During the 7-day follow-up period following vaccination after each vaccine dose

• Occurrence, intensity and relationship to vaccination of unsolicited symptoms

  During the 30-day follow-up period following vaccination after each vaccine dose

• Occurrence and relationship to vaccination of serious adverse events

  During the entire study period

• Haematological and biochemical levels

  At protocol defined time points

Secondary Outcomes (2)

• Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry

  At protocol defined time points

• Antibody titres to M72 measured by ELISA

  At protocol defined time points

Study Arms (1)

Group A

EXPERIMENTAL

These subjects were further stratified into 3 groups according to the size of their PPD skin test reactions

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

Interventions

GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342) BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Group A

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Worcester, Western Province, 6850, South Africa

Location

Related Publications (1)

• Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, Erasmus M, Makhethe L, Hughes EJ, Gelderbloem S, Bollaerts A, Bourguignon P, Cohen J, Demoitié MA, Mettens P, Moris P, Sadoff JC, Hawkridge A, Hussey GD, Mahomed H, Ofori-Anyinam O, Hanekom WA. Induction and regulation of T-cell immunity by the novel tuberculosis vaccine M72/AS01 in South African adults. PMID:23306546

  BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 25, 2008
• Study Start: February 5, 2008
• Primary Completion: December 19, 2008
• Study Completion: December 19, 2008
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

ZA (1)