TuberculosisPhase 1THYB-02NCT00929396
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
A Phase 1 study testing 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) in people with Tuberculosis, run by Statens Serum Institut at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female between 18 and 55 years old
- BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
- Infection group: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
- Healthy based on medical examination/history at the inclusion
- Signed informed consent
- Prepared to grant authorized persons access to the medical records
- The volunteer is likely to comply with instructions
Who cannot join
- Granulomatous disease (by chest X-ray)
- Vaccinated with live vaccine 3 months before first vaccination
- Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
- HBV, HCV or HIV sero-positive
- Participation in other clinical trials
- Known hypersensitivity to any of the vaccine components
- Laboratory parameters outside of normal range judged by PI to be clinically relevant
- Pregnant women/planned pregnancy and/or breastfeeding within the trial period
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Centre
Leiden, RC Leiden, 2300
About this study
Official title: A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)Administered in PPD Positive Volunteers at 0 and 2 Months
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
- Conditions
- Tuberculosis
- Being tested
- 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
- Keywords
- Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)Biological
Also called Antigen H1 + adjuvant IC31
o,5 mL suspension for injection x 2 with 2 months interval
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)Biological
Also called Antigen H1 + adjuvant IC31
o,5 mL suspension for injection x 2 with 2 months interval
| Study group | Role | What they receive |
|---|---|---|
| Latent TB infection group | Experimental | The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart. Receives: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) |
| BCG vaccinated group | Experimental | The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart Receives: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests.
Measured: From first vaccination until 8 months after the first vaccination
Secondary outcomes (1)
Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum
Measured: From first vaccination until 8 months after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaap van Dissel, MD, Prof., Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929396
- Sponsor's protocol ID
- THYB-02
- Acronym
- THYB-02
- Status last verified
- Jan 2013
- First submitted
- 26 Jun 2009
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.
PubMed 21256189
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)Administered in PPD Positive Volunteers at 0 and 2 Months
- ClinicalTrials.gov ID
- NCT00929396
- Acronym / sponsor ID
- THYB-02 / THYB-02
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latent TB infection group | Experimental | Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart. |
| BCG vaccinated group | Experimental | Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female between 18 and 55 years old
- BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
- Infection group: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
- Healthy based on medical examination/history at the inclusion
- Signed informed consent
Key exclusion criteria (8 listed)
- Granulomatous disease (by chest X-ray)
- Vaccinated with live vaccine 3 months before first vaccination
- Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
- HBV, HCV or HIV sero-positive
- Participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)Also: Antigen H1 + adjuvant IC31o,5 mL suspension for injection x 2 with 2 months interval | Biological | BCG vaccinated group |
| 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)Also: Antigen H1 + adjuvant IC31o,5 mL suspension for injection x 2 with 2 months interval | Biological | Latent TB infection group |
Primary outcome
Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests.
Time frame: From first vaccination until 8 months after the first vaccination
1 secondary outcome
Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum
Time frame: From first vaccination until 8 months after first vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 21256189van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap van Dissel, MD, Prof. principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) in people with Tuberculosis, run by Statens Serum Institut at 1 site in Netherlands.
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 7 inclusion and 8 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 21 Jan 2013. 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 Netherlands. 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?
Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests. (time frame: From first vaccination until 8 months after the first vaccination). 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 NCT00929396, which also lists 1 linked publication.
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 21 Jan 2013.