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
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
1 other identifier
interventional
38
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 21, 2013
January 1, 2013
2 years
June 16, 2009
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
one year after first vaccination
Secondary Outcomes (1)
Immunogenicity
one year after the first vaccination
Study Arms (4)
50 µg Ag85B-ESAT-6 alone
EXPERIMENTAL50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
EXPERIMENTAL50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
EXPERIMENTAL50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
EXPERIMENTALInterventions
0.5 mL solution for injection x 2 (2 months interval)
0,5 mL suspension for injection x 2 (2 months interval)
0.5 mL suspension for injection x 2 (2 months interval)
0.5 mL suspension for injection x 2 (2 months interval)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of infectious diseases, C5-P, LUMC
Leiden, NL-2300 RC, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 21, 2013
Record last verified: 2013-01