Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.

NCT00291889 | Completed Phase 1

• 1 other identifier: 102039
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.

Conditions

Tuberculosis (TB)

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study

Secondary Outcomes (1)

• Immunogenicity as assessed by humoral and CMI response.

Interventions

Mtb72F/AS02. BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Healthy PPD-negative volunteers aged 18 to 45 years
• No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
• Seronegative for HIV 1 and 2, HBsAg, and HCV
• Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
• Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

You may not qualify if:

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• History of prior Bacillus Calmette-Guérin (BCG) vaccination.
• History of documented exposure to Mycobacterium tuberculosis
• History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
• Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
• History of hypersensitivity to vaccines or vaccine components
• History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: July 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

BE (1)