Status:
COMPLETED
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
Lead Sponsor:
Serum Life Science Europe GmbH
Conditions:
Tuberculosis
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in e...
Eligibility Criteria
Inclusion
- Male volunteers 18 to 55 years of age.
- Healthy (medical history, physical examination, vital signs, ECG and laboratory tests at screening).
- No signs of active or latent tuberculosis infection.
- BMI of 19 - 30 kg/m2.
- Subjects must be able and willing to comply with the study protocol, available and willing to complete all study measurements and have signed an Informed Consent form approved by the Ethics Committee.
- Intention not to travel to endemic regions for tuberculosis (such as Africa, Asia, former USSR) and reachable by phone during the whole study period (6 months).
- Negative test for HIV1 and HIV2, hepatitis B surface antigen and antibody to hepatitis C virus .
- No anamnestic evidence for a primary or secondary immunodeficiency.
- No skin eczema lesion at the intended injection site.
- No anamnestic predisposition for scarring badly or for keloid formation.
- No other vaccination during eight weeks before and during the follow-up period of the current study. If a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
- No participation in another clinical trial within 3 months before study vaccination and the 6 months of the current study.
- Able and willing to abstain from physical exercise 24 hours before screening examination, and from 24 hours before admission until discharge from the clinic.
- No blood donation for non study-related purposes during the entire duration of the study.
- normal sonographic liver imaging
Exclusion
- For the group of volunteers who were vaccinated with a BCG vaccine:
- • Tuberculin-PPD-in-vivo-test equal or more than 10 mm at baseline
- For the group of naive volunteers:
- • Tuberculin-PPD-in-vivo-Test equal or more than 1 mm at baseline
- For all volunteers
- systemic disorders which could interfere with the interpretation of the study results or compromise the health of the volunteers.
- BCG-vaccination during 10 years before study vaccination.
- Acute fever or fever in the last 7 days before dosing.
- Any malignant condition.
- Concomitant treatment with medication that may affect immune function during 3 months before study vaccination and the 6 months of current study.
- Treatment with blood products or Immunoglobulins in the past 6 months up to end of study.
- Any clinically significant laboratory abnormalities on screened blood samples.
- A history of drug or alcohol abuse.
- History of anaphylaxis or severe allergic reactions.
- Positive test for drugs of abuse on urine testing at screening or admission.
- Known allergies to any component of the investigational or reference product or known history of severe skin reaction against the Tuberculin test.
- Professional or regular contact with life animals for food production.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00749034
Start Date
September 1 2008
End Date
December 1 2009
Last Update
May 20 2010
Active Locations (1)
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1
Focus Clinical Drug Development GmbH
Neuss, Germany, 41460