A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine (Ag85B - ESAT-6 + IC31) administered in PPD positive volunteers at 0 and 2 months

Completed

Conditions: Prevention
Tuberculosis
10028440

Registration Number: NL-OMON30684

Lead Sponsor: Statens Serum Institut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

BCG-group: BCG-vaccinated > two years before, PPD+ (range 6-15mm) or any documented value between 6-15mm 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 diagnosed with latent TB, PPD+, 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
Age between 18 and 55 ears
Signed informed consent

Exclusion Criteria

Granulomatous disease other then TB
Vaccinated with live vaccine 3 months before the first vaccination
Administration of immune modilating drugs 3 months before first vaccination
HBV, HCV, or HIV sero-positive
Participation in another clinical trial
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 trail period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary variables:<br /><br>A. Physical examination, including ENT, cardiovasculair, pulmonary,<br /><br>neurological, gastrointestinal, urogenital and dermatological systems, as well<br /><br>as injection sites<br /><br>B. Local adverse events, including pain, erythema, urticaria, asthma,<br /><br>angiooedema, fatigue, fever, arthralgia, myalgia, hoarseness, dizziness,<br /><br>malaise, paleness, sweating, nausea, arrhytmia, headache and anaphylaxis<br /><br><br /><br>Laboratory safett tests:<br /><br>D. Blood samples will be tested for RBC, differential WBC, platelets,<br /><br>hemoglobin, hematocrit, ASAT, ALAT, alkaline phosphatase, lactate<br /><br>dehydrogenase, gamma GT, albumin, bilirubin, creatine, glucose, potassium,<br /><br>sodium<br /><br>E. Urine samples will be tested for glucose, protein and sediment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary variables:<br /><br>A. Detection by elispot of IFN-gamma spot-forming cells in PBMC's after<br /><br>stimulation with Ag85B, Esat-6 and H1<br /><br>B. Detection by ELISA of IFN-gamma production in supernatants of PBM stimulated<br /><br>with Ag85B, ESAT and H1.<br /><br>C. Detection by ELISA of IgG antibodies to recombinant proteins Ag85B, ESAT-6<br /><br>and H! in serum/plasma.<br /><br>D. Detection by ELISA of TNF-gamma in serum before and one day after<br /><br>vaccination.<br /><br><br /><br>Quantiferon TB-Gold In Tube Test</p><br>