Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents

NCT ID: NCT00950612

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-08
• Study Completion Date: 2010-09-30

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.

Conditions

Tuberculosis

Study Design

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

Study Groups

Group A

Group Type: EXPERIMENTAL

GSK's investigational vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Interventions

GSK's investigational vaccine 692342

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

Placebo

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aeras

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Worcester, Western Province, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 26072017 (View on PubMed)

Other Identifiers

112898

Identifier Type: -

Identifier Source: org_study_id