Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

NCT ID: NCT00707967

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-05-27

Brief Summary

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Subjects receiving the candidate vaccine

Group Type: EXPERIMENTAL

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Group B

Subjects receiving the adjuvant

Group Type: PLACEBO_COMPARATOR

Control vaccine with the adjuvant system.

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Group C

Subjects receiving physiological saline

Group Type: PLACEBO_COMPARATOR

Control vaccine with physiological saline

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Interventions

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Control vaccine with the adjuvant system.

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Control vaccine with physiological saline

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Lausanne, , Switzerland

Countries

Switzerland

References

Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitie MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.

Reference Type: DERIVED

PMID: 24911353 (View on PubMed)

Roy-Ghanta S, Van der Most R, Li P, Vaughn DW. Responses to A(H1N1)pdm09 influenza vaccines in participants previously vaccinated with seasonal influenza vaccine: a randomized, observer-blind, controlled study. J Infect Dis. 2014 Nov 1;210(9):1419-30. doi: 10.1093/infdis/jiu284. Epub 2014 May 26.

Reference Type: DERIVED

PMID: 24864125 (View on PubMed)

Other Identifiers

111517

Identifier Type: -

Identifier Source: org_study_id