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OpenTrials
Completed

NCT Number: NCT01003093

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Leiden University Medical Centre

Leiden, RC Leiden, 2300, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Healthy based on medical examination/history at the inclusion
  • Age between 18 and 55 years
  • Signed informed consent
  • Prepared to grant authorized persons access to the medical records
  • The volunteer is likely to comply with instructions

Exclusion criteria

  • Known exposure to TB before (or expected during) the trial
  • Prior BCG vaccination
  • Granulomatous disease (by chest X-ray, autoimmune screen)
  • Vaccinated with live vaccine 3 months before first vaccination
  • Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
  • HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
  • Participation in other clinical trials
  • Positive Mantoux or QuantiFERON-TB Gold
  • Known hypersensitivity to any of the vaccine components
  • Laboratory parameters outside of normal ranges considered clinically relevant

Treatment and study plan

50 microgram antigen (Ag85B + ESAT-6)

Biological

0.5 mL suspension for injection x 2 with 2 months interval

Other names: Antigen H1

50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a

Biological

0.5 mL suspension for injection x 2 with 2 months interval

Other names: Antigen H1 + IC31

50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a

Biological

0.5 mL suspension for injection x 2 with 2 months interval

Other names: Antigen H1 + IC31

Primary outcomes

  1. Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.

    Time frame: From the first vaccination until 8 months after the first vaccination

Secondary outcomes

  1. Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.

    Time frame: From first vaccination until 36 months after first vaccination

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study title

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months

Acronym: THYB-01

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 28, 2009
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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