Clinical trial NCT00950612: Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Aeras
First posted: 2009-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol.
* A male or female between, and including, 13 and 17 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject's parent(s) or legal guardian(s).
* Written informed assent obtained from the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Seronegative for HIV-1.
* No history of TB disease.
* No active pulmonary disease on chest X-ray.
* Availability for the duration of the immunisation and follow-up period, with the family not planning to move away from the study area within the next year.
* 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 is abstinent, has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* 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 investigational Mycobacterium tuberculosis vaccines.
* History of previous exposure to components of the investigational vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* 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 study vaccine.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of vaccine, or planned administration during the study.
* Planned participation or participation in another experimental clinical study during the study period.
* A family history of congenital or hereditary immunodeficiency.
* 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 and Specific Serotonin Reuptake Inhibitors (SSRIs).
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to any vaccine.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
* Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions.
* Drug and/or alcohol abuse

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 up to Day 210)
measure: Number of Subjects With Normal Biochemical and Haematological Levels
timeFrame: At Day 0, 7, 30, 37 and 60
measure: Number of Subjects With Normal Haematological Levels
timeFrame: At Day 0, 7, 30, 37 and 60
measure: Number of Subjects With Biochemical and Haematological Above Normal Levels
timeFrame: At Day 0, 7, 30, 37 and 60
measure: Number of Subjects With Haematological Levels Above Normal
timeFrame: At Day 0, 7, 30, 37 and 60
measure: Number of Subjects With Biochemical and Haematological Below Normal Levels
timeFrame: At Day 0, 7, 30, 37 and 60
measure: Number of Subjects With Haematological Levels Below Normal
timeFrame: At Day 0, 7, 30, 37 and 60
Secondary outcomes:
measure: Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
timeFrame: At Day 0, 7, 30, 37, 60 and 210
measure: Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines
timeFrame: At Day 0, 7, 30, 37, 60 and 210
measure: Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines
timeFrame: At Day 0, 7, 30, 37, 60 and 210
measure: Anti-M72 Specific Antibody Concentrations
timeFrame: At Day 0, 30, 60 and 210
Other outcomes:
Locations:
city: Worcester
country: South Africa
facility: GSK Investigational Site
state: Western Province
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Penn-Nicholson A, Geldenhuys H, Burny W, van der Most R, Day CL, Jongert E, Moris P, Hatherill M, Ofori-Anyinam O, Hanekom W; Vaccine Study Team; Bollaerts A, Demoitie MA, Kany Luabeya AK, De Ruymaeker E, Tameris M, Lapierre D, Scriba TJ. Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting. Vaccine. 2015 Jul 31;33(32):4025-34. doi: 10.1016/j.vaccine.2015.05.088. Epub 2015 Jun 10.