Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults

NCT00146744 | Completed Phase 2

• 1 other identifier: 102374
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.

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/AS02A BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Healthy PPD-positive volunteers aged 18 to 50 years
• No active pulmonary disease as confirmed by chest X-ray
• No history of extrapulmonary TB
• 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 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

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• Spertini F, Audran R, Lurati F, Ofori-Anyinam O, Zysset F, Vandepapeliere P, Moris P, Demoitie MA, Mettens P, Vinals C, Vastiau I, Jongert E, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02 in PPD positive adults: a randomized controlled phase I/II study. Tuberculosis (Edinb). 2013 Mar;93(2):179-88. doi: 10.1016/j.tube.2012.10.011. Epub 2012 Dec 5.

  PMID: 23219236 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Mtb72F-AS02A vaccine

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: July 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CH (1)