Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers

May 19, 2010 updated by: Vakzine Projekt Management GmbH

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

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 endemic areas and persons at risk in non-endemic areas. The new live vaccine VPM1002 should be at least as potent as the currently used BCG vaccine and should cause fewer side effects (Kaufmann, 2007; Grode et al., 2005). It is formulated as lyophilised bacteria to be resuspended before intradermal injection. First application of VPM1002 in human male volunteers will evaluate its safety, local and systemic tolerability as well as its immunogenicity. The study has a dose-escalating sequential design with comparison to commercially available BCG. 80 volunteers in Germany will randomly be allocated to 4 groups each with 20 volunteers stratified for their history of BCG-vaccination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • FOCUS Clinical Drug Development GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male volunteers 18 to 55 years of age.
  2. Healthy (medical history, physical examination, vital signs, ECG and laboratory tests at screening).
  3. No signs of active or latent tuberculosis infection.
  4. BMI of 19 - 30 kg/m2.
  5. 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.
  6. 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).
  7. Negative test for HIV1 and HIV2, hepatitis B surface antigen and antibody to hepatitis C virus .
  8. No anamnestic evidence for a primary or secondary immunodeficiency.
  9. No skin eczema lesion at the intended injection site.
  10. No anamnestic predisposition for scarring badly or for keloid formation.
  11. 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.
  12. No participation in another clinical trial within 3 months before study vaccination and the 6 months of the current study.
  13. Able and willing to abstain from physical exercise 24 hours before screening examination, and from 24 hours before admission until discharge from the clinic.
  14. No blood donation for non study-related purposes during the entire duration of the study.
  15. normal sonographic liver imaging

Exclusion Criteria:

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

  1. systemic disorders which could interfere with the interpretation of the study results or compromise the health of the volunteers.
  2. BCG-vaccination during 10 years before study vaccination.
  3. Acute fever or fever in the last 7 days before dosing.
  4. Any malignant condition.
  5. Concomitant treatment with medication that may affect immune function during 3 months before study vaccination and the 6 months of current study.
  6. Treatment with blood products or Immunoglobulins in the past 6 months up to end of study.
  7. Any clinically significant laboratory abnormalities on screened blood samples.
  8. A history of drug or alcohol abuse.
  9. History of anaphylaxis or severe allergic reactions.
  10. Positive test for drugs of abuse on urine testing at screening or admission.
  11. Known allergies to any component of the investigational or reference product or known history of severe skin reaction against the Tuberculin test.
  12. Professional or regular contact with life animals for food production.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 1
VPM1002 in three dosages
Biological: VPM1002
live vaccine
ACTIVE_COMPARATOR: 2
BCG
Biological: BCG
commercially available live vaccine BCG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
days -1, 1, 2, 3, 5, 11, 29, 57 and month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Immunogenicity: LST for PPD with subsequent IFN-gamma specific ELISA on supernatants of PBMC
Time Frame: baseline, days 29, 57, month 6
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
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
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
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
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
baseline, days 29, 57 and month 6
Immunogenicity: serum antibodies against PPD or AG85B
Time Frame: baseline, days 29, 57 and month 6
baseline, days 29, 57 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vakzine Projekt Management GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Schrödter, MD, FOCUS CDD GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VPM1002-GE-1.01TB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings