A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
C-010-402
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
1 other identifier
interventional
72
1 country
1
Brief Summary
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 study day 0 and study day 42 of AERAS-402 or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
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
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedResults Posted
Study results publicly available
May 4, 2016
CompletedMay 4, 2016
April 1, 2016
1.7 years
April 8, 2015
March 4, 2016
April 1, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants With Solicited and Unsolicited AEs
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
Forced Expiratory Volume in One Second (FEV1)
Maximum number of subjects with deterioration \>10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)
182 days
Forced Vital Capacity (FVC)
Maximum number of subjects with deterioration \>10% from baseline, at any time point, in forced vital capacity (FVC)
182 days
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Maximum number of subjects with deterioration \>15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)
182 Days
Secondary Outcomes (4)
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
42 days post dose
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo control: 1.0 mL sterile buffer containing 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water.
AERAS-402 3 x 10^8 vp
EXPERIMENTALAERAS-402: 1.0 mL containing 3 x 10\^8 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water.
AERAS-402 3 x 10^9 vp
EXPERIMENTALAERAS-402: 1.0 mL containing 3 x 10\^9 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water.
AERAS-402 3 x 10^10 vp
EXPERIMENTALAERAS-402: 1.0 mL containing 3 x 10\^10 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water.
Interventions
This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.
Eligibility Criteria
You may qualify if:
- Is male or female.
- Is age 18 through 45 years on Study Day 0.
- Has completed the written informed consent process.
- 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.
- 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.
- 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.
- Agrees to avoid elective surgery for the full duration of the study.
- For female subjects: agrees to avoid pregnancy for the full duration of the study.
- 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.
- Has completed simultaneous enrollment in Aeras Vaccine Development Registry Protocol.
You may not qualify if:
- Fever ≥37.5°C.
- Evidence of a new acute illness that may compromise the safety of the subject in the study.
- Evidence of any significant active infection other than tuberculosis.
- Evidence of central nervous system tuberculosis or pleural tuberculosis.
- 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.
- Evidence of any systemic disease or any acute or chronic illness that may interfere with the evaluation of the safety of the vaccine.
- 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Received any investigational drug therapy or vaccine within 182 days before the first dose of study vaccine in this protocol.
- Received any adenovirus-based vaccine previously.
- For female subjects: Currently pregnant, lactating/nursing, or a positive serum or urine βhCG
- Severe anemia, defined as a hemoglobin less than 10 g/dL or a hematocrit less than 30 percent.
- Urine toxicology screen positive for opiates, cocaine, or amphetamines.
- Anal intercourse with another man at least one time (with or without condoms).
- Exchange of goods, money, services or drugs for sex.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aeraslead
- Crucell Holland BVcollaborator
Study Sites (1)
University of Cape Town Lung Institute Pty (Ltd)
Cape Town, Mowbray, 7700, South Africa
Related Publications (1)
van Zyl-Smit RN, Esmail A, Bateman ME, Dawson R, Goldin J, van Rikxoort E, Douoguih M, Pau MG, Sadoff JC, McClain JB, Snowden MA, Benko J, Hokey DA, Rutkowski KT, Graves A, Shepherd B, Ishmukhamedov S, Kagina BMN, Abel B, Hanekom WA, Scriba TJ, Bateman ED. Safety and Immunogenicity of Adenovirus 35 Tuberculosis Vaccine Candidate in Adults with Active or Previous Tuberculosis. A Randomized Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1171-1180. doi: 10.1164/rccm.201603-0654OC.
PMID: 28060545DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ann Ginsberg, Chief Medical Officer
- Organization
- Aeras
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Bateman, MD
University of Cape Town Lung Institute Pty (Ltd)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 13, 2015
Study Start
October 1, 2008
Primary Completion
July 1, 2010
Study Completion
November 1, 2010
Last Updated
May 4, 2016
Results First Posted
May 4, 2016
Record last verified: 2016-04