TuberculosisPhase 1NCT00922363
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
A Phase 1 study testing 50 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 and 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 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 CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval. 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 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 and 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Oct 2011
- 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
- Female or male adult between 18 and 55 years of age
- Healthy according to medical history and medical examinations at screening
- Signed informed consent
- Prepared to grant authorized persons access to medical records
- Likely to comply with instructions
Who cannot join
- History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
- Positive Tuberculin Skin Test (TST) result at screening
- Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
- BCG vaccination any time before entering the trial
- History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
- Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
Show all 18Show fewer
- ANA-Titer, HBV, HCV, HIV sero-positive at screening
- C-reactive protein level > 50 mg/L at screening
- Clinically significant abnormal laboratory test results at screening as assessed by the investigator
- Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
- A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
- Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
- Known hypersensitivity to any of the vaccine components of the investigational vaccines
- Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen
- Pregnant according to a urine pregnancy test at inclusion
- Females not willing to use contraceptives or breast feeding
- Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of infectious diseases, C5-P, LUMC
Leiden, NL-2300 RC
About this study
Official title: An Open Phase I, Dose-escalating, Clinical Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
- Conditions
- Tuberculosis
- Being tested
- 50 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01, 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01, 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
- Keywords
- safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 µg Ag85B-ESAT-6 aloneBiological
0.5 mL solution for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01Biological
0,5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01Biological
0.5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01Biological
0.5 mL suspension for injection x 2 (2 months interval)
| Study group | Role | What they receive |
|---|---|---|
| 50 µg Ag85B-ESAT-6 alone | Experimental | Not described Receives: Biological: 50 µg Ag85B-ESAT-6 alone |
| 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 | Experimental | Not described Receives: Biological: 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 | Experimental | Not described Receives: Biological: 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01 | Experimental | Not described Receives: Biological: 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: one year after first vaccination
Secondary outcomes (1)
Immunogenicity
Measured: one year after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922363
- Sponsor's protocol ID
- ACAF01-01
- Status last verified
- Jan 2013
- First submitted
- 16 Jun 2009
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
- An Open Phase I, Dose-escalating, Clinical Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00922363
- Acronym / sponsor ID
- ACAF01-01
- Conditions
- Tuberculosis
- Keywords
- safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 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 CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 µg Ag85B-ESAT-6 alone | Experimental | Biological: 50 µg Ag85B-ESAT-6 alone |
| 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 | Experimental | Biological: 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 | Experimental | Biological: 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01 | Experimental | Biological: 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female or male adult between 18 and 55 years of age
- Healthy according to medical history and medical examinations at screening
- Signed informed consent
- Prepared to grant authorized persons access to medical records
- Likely to comply with instructions
Key exclusion criteria (18 listed)
- History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
- Positive Tuberculin Skin Test (TST) result at screening
- Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
- BCG vaccination any time before entering the trial
- History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
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 µg Ag85B-ESAT-6 alone0.5 mL solution for injection x 2 (2 months interval) | Biological | 50 µg Ag85B-ESAT-6 alone |
| 50 µg Ag85B-ESAT-6 + 125/25 µg CAF010,5 mL suspension for injection x 2 (2 months interval) | Biological | 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 313/63 µg CAF010.5 mL suspension for injection x 2 (2 months interval) | Biological | 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 |
| 50 µg Ag85B-ESAT-6 + 625/125 µg CAF010.5 mL suspension for injection x 2 (2 months interval) | Biological | 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01 |
Primary outcome
Adverse events
Time frame: one year after first vaccination
1 secondary outcome
Immunogenicity
Time frame: one year after the 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.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
The record lists no contact. Use the official record to reach the sponsor.
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 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01 and 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 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 5 inclusion and 18 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?
Adverse events (time frame: one year after first vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.