Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
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|ClinicalTrials.gov Identifier: NCT00749034|
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : May 20, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis Healthy||Biological: VPM1002 Biological: BCG||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open Label, Randomized, Controlled, Dose-Escalation Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers Stratified for History of BCG-Vaccination|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
VPM1002 in three dosages
Active Comparator: 2
commercially available live vaccine BCG
- Safety: physical examination, vital signs, ECG, liver sonography, chest X-ray, laboratory safety parameters (including haematology, coagulation, clinical chemistry and urinalysis), tolerability, recording of concomitant medication and adverse events [ Time Frame: days -1, 1, 2, 3, 5, 11, 29, 57 and month 6 ]
- Immunogenicity: LST for PPD with subsequent IFN-gamma specific ELISA on supernatants of PBMC [ Time Frame: baseline, days 29, 57, month 6 ]
- Immunogenicity: ELISPOT for the number of IFN-gamma secreting PBMC after stimulation with PPD [ Time Frame: baseline, days 29, 57, month 6 ]
- Immunogenicity: whole blood stimulated with PPD and measuring IFN-gamma in the plasma by ELISA [ Time Frame: baseline, days 29, 57, month 6 ]
- ICS for IFN-gamma, TNF-alpha and IL-2 in CD4+ and CD8+ lymphocytes upon stimulation with PPD [ Time Frame: baseline, days 29, 57 and month 6 ]
- Immunogenicity: ICS with other triple combinations of markers in CD4+ and CD8+ lymphocytes upon stimulation with PPD [ Time Frame: baseline, days 29, 57 and month 6 ]
- Immunogenicity: TB85B as recall antigen for ELISA, ELISPOT, WBA and ICS [ Time Frame: baseline, days 29, 57 and month 6 ]
- Immunogenicity: serum antibodies against PPD or AG85B [ Time Frame: baseline, days 29, 57 and month 6 ]
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- 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
For the group of volunteers who were vaccinated with a BCG vaccine:
â€¢ Tuberculin-PPD-in-vivo-test equal or more than 10 mm at baseline
For the group of naive volunteers:
â€¢ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749034
|Focus Clinical Drug Development GmbH|
|Neuss, Germany, 41460|
|Principal Investigator:||Andreas Schrödter, MD||FOCUS CDD GmbH|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Dr. Hans-Heinrich Henneicke - v. Zepelin / CPM, Vakzine Projekt Management GmbH|
|Other Study ID Numbers:||
|First Posted:||September 9, 2008 Key Record Dates|
|Last Update Posted:||May 20, 2010|
|Last Verified:||April 2010|
Vaccination against tuberculosis
Safety and immunogenicity of VPM1002 in comparison with BCG
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses