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| Sponsor: | Aeras Global Tuberculosis Vaccine Foundation |
|---|---|
| Collaborator: |
Crucell Holland BV |
| Information provided by: | Aeras Global Tuberculosis Vaccine Foundation |
| ClinicalTrials.gov Identifier: | NCT01017536 |
Purpose
This is a Phase II double-blinded, randomized, placebo-controlled study to evaluate the safety and immunogenicity of AERAS-402 in HIV-infected, BCG-vaccinated adults with CD4+ lymphocyte counts greater than 350 cells/mm^3.
This study consists of 900 adult subjects (ages 21-45 years of age inclusive) who will receive study vaccine or control at study days 0 and 28.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis HIV Infections |
Biological: AERAS-402 Biological: Placebo Control |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of AERAS-402 in HIV-infected, BCG-vaccinated Adults With CD4+ Lymphocyte Counts Greater Than 350 Cells/mm3 |
| Estimated Enrollment: | 900 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Buffer: Placebo Comparator
A maximum of 450 subjects will receive placebo vaccine that does not contain any AERAS-402.
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Biological: Placebo Control
Placebo will be supplied in vials containing extractable 1.0 mL sterile buffer containing 10 mmol/mL Tris Buffer, 1 mmol/mL MgCl2, 75 mmol/mL NaCl, 5% w/v sucrose, 0.02% w/v polysorbate-80, Water, 0.1 mmol/mL EDTA, 10 mmol/mL l-histidine, 0.5% v/v ethanol. This is the identical buffer solution in which AERAS-402 is formulated.
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Investigational Vaccine: Experimental
A maximum of 450 subjects will receive active vaccine that contains 3 x 10^10 vp / 0.5mL AERAS-402.
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Biological: AERAS-402
AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein created from the sequences of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4. Dosage will contain 3.0 x 10^10 vp per 0.5mL.
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Further study details as provided by Aeras Global Tuberculosis Vaccine Foundation.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gavin Churchyard, MD, PhD | +27-11-638-2253 | gchurchyard@auruminstitute.org |
| Contact: Kathy Mngadi, MD | +27-18-406-4200 | kmngadi@auruminstitute.org |
| South Africa, North-West | |
| Aurum Institute | |
| Klerksdorp, North-West, South Africa, 2570 | |
| Principal Investigator: | Gavin Churchyard, MD, PhD | Aurum Institute |
| Study Director: | Bernard Landry, MPH | Aeras Global TB Vaccine Foundation |
More Information
| Responsible Party: | Aeras Global Tuberculosis Vaccine Foundation ( Dale Wierenga, Ph.D., Senior Director, Regulatory Affairs ) |
| Study ID Numbers: | C-017-402 |
| Study First Received: | November 18, 2009 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT01017536 History of Changes |
| Health Authority: | South Africa: Medicines Control Council |
|
HIV Tuberculosis Vaccine |
|
Bacterial Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Actinomycetales Infections Immunologic Deficiency Syndromes |
Virus Diseases Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Tuberculosis Retroviridae Infections |