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TuberculosisPhase 1NCT00749034

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

A Phase 1 study testing VPM1002 and BCG in people with Tuberculosis and Healthy, run by Serum Life Science Europe GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 endemic areas and persons at risk in non-endemic areas. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Tuberculosis, Healthy
What is being tested?
VPM1002 and BCG
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteGermany
Study dates
Sep 2008to Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Focus Clinical Drug Development GmbH

    Neuss, 41460

Other trials in Germany

About this study

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

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.

Being tested
VPM1002, BCG
Keywords
Safety, Immunogenicity, Tuberculosis, Vaccination, Vaccination against tuberculosis, Safety and immunogenicity of VPM1002 in comparison with BCG
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VPM1002Biological

    live vaccine

  • BCGBiological

    commercially available live vaccine BCG

Study groups in NCT00749034
Study groupRoleWhat they receive
1ExperimentalVPM1002 in three dosages
Receives: Biological: VPM1002
2Active comparatorBCG
Receives: Biological: BCG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: days -1, 1, 2, 3, 5, 11, 29, 57 and month 6

Secondary outcomes (7)

  1. Immunogenicity: LST for PPD with subsequent IFN-gamma specific ELISA on supernatants of PBMC

    Measured: baseline, days 29, 57, month 6

  2. Immunogenicity: ELISPOT for the number of IFN-gamma secreting PBMC after stimulation with PPD

    Measured: baseline, days 29, 57, month 6

  3. Immunogenicity: whole blood stimulated with PPD and measuring IFN-gamma in the plasma by ELISA

    Measured: baseline, days 29, 57, month 6

  4. ICS for IFN-gamma, TNF-alpha and IL-2 in CD4+ and CD8+ lymphocytes upon stimulation with PPD

    Measured: baseline, days 29, 57 and month 6

  5. Immunogenicity: ICS with other triple combinations of markers in CD4+ and CD8+ lymphocytes upon stimulation with PPD

    Measured: baseline, days 29, 57 and month 6

  6. Immunogenicity: TB85B as recall antigen for ELISA, ELISPOT, WBA and ICS

    Measured: baseline, days 29, 57 and month 6

  7. Immunogenicity: serum antibodies against PPD or AG85B

    Measured: baseline, days 29, 57 and month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749034
Sponsor's protocol ID
VPM1002-GE-1.01TB
Status last verified
Apr 2010
First submitted
5 Sep 2008
Last updated
20 May 2010
Results posted
No
Data monitoring committee
No

Publications

  • Choi SW, Han S, Shim WJ, Choi DJ, Kim YJ, Yoo BS, Hwang KK, Jeon HK, Shin MS, Ryu KH. Impact of Heart Rate Reduction with Maximal Tolerable Dose of Bisoprolol on Left Ventricular Reverse Remodeling. J Korean Med Sci. 2018 May 11;33(25):e171. doi: 10.3346/jkms.2018.33.e171. eCollection 2018 Jun 18.

    PubMed 29915522

  • Grode L, Ganoza CA, Brohm C, Weiner J 3rd, Eisele B, Kaufmann SH. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine. 2013 Feb 18;31(9):1340-8. doi: 10.1016/j.vaccine.2012.12.053. Epub 2013 Jan 3.

    PubMed 23290835

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VPM1002 and BCG in people with Tuberculosis and Healthy, run by Serum Life Science Europe GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2010.

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