Last updated: 11/07/2018 05:19:27
Safety and immunogenicity of a candidate Tuberculosis (TB) vaccine in healthy HIV negative adolescents
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 up to Day 210)
Number of subjects with normal biochemical and haematological levels
Timeframe: At Day 0, 7, 30, 37 and 60
Number of subjects with normal haematological levels
Timeframe: At Day 0, 7, 30, 37 and 60
Number of subjects with biochemical and haematological above normal levels
Timeframe: At Day 0, 7, 30, 37 and 60
Number of subjects with haematological levels above normal
Timeframe: At Day 0, 7, 30, 37 and 60
Number of subjects with biochemical and haematological below normal levels
Timeframe: At Day 0, 7, 30, 37 and 60
Number of subjects with haematological levels below normal
Timeframe: At Day 0, 7, 30, 37 and 60
Secondary outcomes:
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
Frequency of M72 specific CD4+ T cells expressing any combination of cytokines
Timeframe: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 specific CD4+ T cells expressing any combination of cytokines
Timeframe: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 specific CD8+ T cells expressing any combination of cytokines
Timeframe: At Day 0, 7, 30, 37, 60 and 210
Frequency of M72 specific CD8+ T cells expressing any combination of cytokines
Timeframe: At Day 0, 7, 30, 37, 60 and 210
Anti-M72 specific antibody concentrations
Timeframe: At Day 0, 30, 60 and 210
Interventions:
Enrollment:
60
Primary completion date:
2010-30-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Penn-Nicholson A et al. (2015) Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting. Vaccine. 33(32):4025-4034.
Medical condition
Tuberculosis
Product
SB692342
Collaborators
Aeras Global Tuberculosis Vaccine Foundation
Study date(s)
December 2009 to September 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
13 - 17 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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
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.
Trial location(s)
Location
GSK Investigational Site
Worcester, Western Province, South Africa, 6850
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-30-09
Actual study completion date
2010-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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