Tuberculosis Clinical Trial
— C-010-402Official title:
A Phase II Double-Blind, Randomized, Placebo-controlled, Dose Escalation Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary Tuberculosis
Verified date | April 2015 |
Source | Aeras |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on days 0 and 56 of AERAS-402 or placebo.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Is male or female. 2. Is age 18 through 45 years on Study Day 0. 3. Has completed the written informed consent process. 4. Has a history of pulmonary tuberculosis diagnosed by either a sputum smear positive for acid-fast bacilli (AFB) or a sputum culture positive for Mtb. 5. Has initiated effective chemotherapy for tuberculosis between one month (30 days) and four months (120 days) before Study Day 0, with improvement in clinical signs and/or symptoms of disease, OR: has initiated effective chemotherapy for tuberculosis at least 12 months (360 days) before Study Day 0, and is considered cured. 6. For subjects currently receiving chemotherapy for tuberculosis they must have been fully compliant with previously prescribed tuberculosis therapy and agree to complete currently prescribed tuberculosis therapy. 7. Agrees to avoid elective surgery for the full duration of the study. 8. For female subjects: agrees to avoid pregnancy for the full duration of the study. 9. Agrees to stay in contact with the study site for the full duration of the study, providing updated contact information as necessary, and has no current plans to move from the study area during the duration of the study. 10. Has completed simultaneous enrollment in Aeras Vaccine Development Registry Protocol. Exclusion Criteria: 1. Fever =37.5°C. 2. Evidence of a new acute illness that may compromise the safety of the subject in the study. 3. Evidence of any significant active infection other than tuberculosis. 4. Evidence of central nervous system tuberculosis or pleural tuberculosis. 5. Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms. 6. Evidence of any systemic disease or any acute or chronic illness that may interfere with the evaluation of the safety of the vaccine. 7. History or laboratory evidence of any past, present or future possible immunodeficiency state, including but not limited to any laboratory indication of HIV-1 infection. 8. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. 9. Received any investigational drug therapy or vaccine within 182 days before the first dose of study vaccine in this protocol. 10. Received any adenovirus-based vaccine previously. 11. For female subjects: Currently pregnant, lactating/nursing, or a positive serum or urine ßhCG 12. Severe anemia, defined as a hemoglobin less than 10 g/dL or a hematocrit less than 30 percent. 13. Urine toxicology screen positive for opiates, cocaine, or amphetamines. 14. Anal intercourse with another man at least one time (with or without condoms). 15. Exchange of goods, money, services or drugs for sex. 16. Use of intravenous drugs. 17. Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual. 18. Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs. 19. Oral to genital contact within the last 12 months with a known user of intravenous drugs. 20. Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner. 21. Oral to genital contact within the last 12 months with an individual known to have more than one sex partner. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town Lung Institute Pty (Ltd) | Cape Town | Mowbray |
Lead Sponsor | Collaborator |
---|---|
Aeras | Crucell Holland BV |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of solicited and unsolicited AEs in subjects. | All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria. | 182 days | Yes |
Secondary | Immunogenicity of AERAS-402 based on the percentage of CD4 and CD8 cells. | Assessment of immune response to AERAS-402 will be based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-?, TNF-a, and/or IL-2) following stimulation with mycobacterial peptide pools containing the entire amino acid sequence of TB10.4 and a peptide pool containing the entire amino acid sequence of Ag85A and non-identical sequence stretches from Ag85B (Ag85A/b peptide pool). Responses will be measured by the intracellular cytokine staining (ICS) assay using flow cytometry. | 182 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |