Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults

NCT ID: NCT01262976

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-17
• Study Completion Date: 2015-06-04

Brief Summary

The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region.

Subjects will be followed-up for 3 years.

Subjects will be enrolled in 3 cohorts:

• HIV-positive adults on highly active antiretroviral therapy
• HIV-positive adults not on highly active antiretroviral therapy
• HIV-negative adults

Each cohort will have 2 groups.

Detailed Description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the outcome measures and the inclusion and exclusion criteria.

Conditions

Tuberculosis

Study Design

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

Study Groups

HIV(+)-HA/GSK692342

HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: EXPERIMENTAL

GSK's investigational vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

HIV(+)-HA/Placebo

HIV-infected subjects between and including 18 to 59 years of age, who were on Highly Active Anti-Retroviral Therapy (HAART) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: PLACEBO_COMPARATOR

Physiological saline

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

HIV(+)-TN/GSK692342

HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: EXPERIMENTAL

GSK's investigational vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

HIV(+)-TN/Placebo

HIV-infected subjects between and including 18 to 59 years of age, who were HAART-treatment naive (TN) at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: PLACEBO_COMPARATOR

Physiological saline

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

HIV(-)/GSK692342

Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of GSK692342 vaccine (TB) at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: EXPERIMENTAL

GSK's investigational vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

HIV(-)/Placebo

Subjects between and including 18 to 59 years of age, who were HIV-negative at the time of study enrolment, received two doses of saline solution at Day 0 and Day 30, intramuscularly into the arm's deltoid region.

Group Type: PLACEBO_COMPARATOR

Physiological saline

Intervention Type: BIOLOGICAL

Intramuscular, 2 doses

Interventions

GSK's investigational vaccine 692342

Intramuscular, 2 doses

Intervention Type: BIOLOGICAL

Physiological saline

Intramuscular, 2 doses

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 59 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination,
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
• Clinically acceptable laboratory values at screening as determined by the investigator.
• No evidence of tuberculosis disease with no evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extra pulmonary tuberculosis.
• Based on their medical history, all subjects must have no history of chemotherapy for tuberculosis.

• Subjects must be HIV-positive and under care of a physician for at least 6 months.
• Subjects must have a CD4+T cell count >= 250 cells/mm3 at screening.
• Subjects must be stable on highly active antiretroviral therapy for at least 6 months, with an undetectable HIV viral load level at screening.

• Subjects must be HIV-positive and under care of a physician for at least 6 months
• Subjects must be highly active antiretroviral therapy-naïve (never received anti-retroviral therapy after HIV diagnosis)
• Subjects must have a CD4 + T cell count above 350 cells/mm3 at screening.
• Subjects for whom commencement of highly active antiretroviral therapy is not expected based on current assessment within next year.
• Subjects must have a viral load between 5000 - 80000 copies/mL at screening.

• Subjects must be negative for HIV-1.

Exclusion Criteria

• Use of any investigational or non-registered product 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 Mtb vaccines.
• History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine
• Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone >= 20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any condition or illness 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 with an experimental product during the study period.
• Administration of any immunoglobulin, 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.
• Subjects taking any of the following medication: chronic administration of systemic steroids, interleukins, systemic interferon or systemic chemotherapy.
• History of allergic reactions or anaphylaxis to any drug or 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.
• Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests.

• Any change in anti-retroviral drug regimen within 12 weeks prior to screening.
• Any chronic drug therapy, other than highly active antiretroviral therapy or prophylaxis for opportunistic HIV related infections, birth control pills, anti-histamines for seasonal allergies and SSRIs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tharamani Chennai, , India

Countries

India

References

Kumarasamy N, Poongulali S, Beulah FE, Akite EJ, Ayuk LN, Bollaerts A, Demoitie MA, Jongert E, Ofori-Anyinam O, Van Der Meeren O. Long-term safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in HIV-positive and -negative Indian adults: Results from a phase II randomized controlled trial. Medicine (Baltimore). 2018 Nov;97(45):e13120. doi: 10.1097/MD.0000000000013120.

Reference Type: DERIVED

PMID: 30407329 (View on PubMed)

Other Identifiers

113935

Identifier Type: -

Identifier Source: org_study_id