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Completed

NCT Number: NCT00922363

Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers

The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.

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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

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of infectious diseases, C5-P, LUMC

Leiden, NL-2300 RC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female or male adult between 18 and 55 years of age
  • Healthy according to medical history and medical examinations at screening
  • Signed informed consent
  • Prepared to grant authorized persons access to medical records
  • Likely to comply with instructions

Exclusion criteria

  • History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
  • Positive Tuberculin Skin Test (TST) result at screening
  • Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
  • BCG vaccination any time before entering the trial
  • History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
  • Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  • ANA-Titer, HBV, HCV, HIV sero-positive at screening
  • C-reactive protein level > 50 mg/L at screening
  • Clinically significant abnormal laboratory test results at screening as assessed by the investigator
  • Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
  • A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  • Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
  • Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
  • Known hypersensitivity to any of the vaccine components of the investigational vaccines
  • Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen
  • Pregnant according to a urine pregnancy test at inclusion
  • Females not willing to use contraceptives or breast feeding
  • Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial

Treatment and study plan

50 µg Ag85B-ESAT-6 alone

Biological

0.5 mL solution for injection x 2 (2 months interval)

50 µg Ag85B-ESAT-6 + 125/25 µg CAF01

Biological

0,5 mL suspension for injection x 2 (2 months interval)

50 µg Ag85B-ESAT-6 + 313/63 µg CAF01

Biological

0.5 mL suspension for injection x 2 (2 months interval)

50 µg Ag85B-ESAT-6 + 625/125 µg CAF01

Biological

0.5 mL suspension for injection x 2 (2 months interval)

Primary outcomes

  1. Adverse events

    Time frame: one year after first vaccination

Secondary outcomes

  1. Immunogenicity

    Time frame: one year after the first vaccination

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study title

An Open Phase I, Dose-escalating, Clinical Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 17, 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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