Tuberculosis Clinical Trial
Official title:
A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
Status | Completed |
Enrollment | 487 |
Est. completion date | April 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 112 Days to 182 Days |
Eligibility |
Inclusion Criteria: 1. Parent/legal guardian has completed the written informed consent process 2. Is age greater than or equal to 112 days (16 weeks) and less than or equal 182 days (26 weeks) on Study Day 0 3. Has general good health, confirmed by medical history and physical examination 4. Is up to date on all Expanded Program of Immunization (EPI) immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0 5. Has ability to complete follow-up period of 728 days as required by the protocol 6. Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study 7. Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol 8. Had BCG vaccination = 3 months prior to randomization documented by medical card Exclusion Criteria: 1. Acute illness, evidence of any significant active infection or temperature >=37.5°C on the day of randomization 2. Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted) 3. Received immunoglobulin or blood products within 45 days before entry into the study 4. Ever received any investigational drug therapy or investigational vaccine 5. History or laboratory evidence of individual immunodeficiency virus (HIV-1) infection 6. History of allergic disease or reactions to any component of the study vaccine 7. Previous medical history that may compromise the safety of the participant in the study 8. Evidence of a new acute illness that may compromise the safety of the participant in the study 9. Inability to discontinue daily medications during the study 10. History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy) 11. History or evidence of active tuberculosis 12. A positive QuantiFERON®-TB Gold In-Tube test 13. A household contact with active TB disease |
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 |
---|---|---|---|
Kenya | Boro Heath Center | Boro | |
Kenya | KEMRI/CDC Research and Public Heath Collaboration | Kisumu | |
Kenya | Siaya District Hospital | Siaya | |
Mozambique | CISM: Centro de Investigacao em Saude de Manhica | Manhica | |
South Africa | Univeristy of Cape Town | Cape Town | |
South Africa | Perinatal HIV Research Unit (PHRU) Chris Hani Baragwanath Hospital | Soweto | |
South Africa | SATVI: Worcester | Worcester |
Lead Sponsor | Collaborator |
---|---|
Aeras | European and Developing Countries Clinical Trials Partnership (EDCTP) |
Kenya, Mozambique, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events Collected Per Subject | Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile | Up to 24 months post vaccination | Yes |
Secondary | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-?, TNF-a, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented. | 28 days post last vaccination | No |
Secondary | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings. | 28 days post last vaccination | No |
Secondary | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4). | 28 day post last vaccination | No |
Secondary | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on >= 0.35IU/mL was considered positive for this study. | up to 24 months post vaccination | No |
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