TuberculosisPhase 1C-021-402NCT02375256
A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402
A Phase 1 study testing AERAS-402 and BCG (1-8 x105 cfu ID) in people with Tuberculosis, run by Aeras.
Trial summary
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- AERAS-402 and BCG (1-8 x105 cfu ID)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is male or female
- Provided written informed consent prior to any study related procedures
- Is age ≥18 years and ≤45 years on Study Day -84.
- Has Body Mass Index (BMI) ≥19 and <33 by nomogram (see appendices)
- Has general good health, confirmed by medical history and physical examination
- Females physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to Study Day -84 through the end of the study.
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- Females physically capable of pregnancy must have a negative serum pregnancy test within 7 days prior to Study Day -84 AND a negative urine pregnancy test on Study Day -84, Study Day 0, and Study Day 28.
- Has committed to avoid elective surgery for the duration of the study
- Has ability to complete all study visits as required per the protocol and is able to be contacted by telephone
Who cannot join
- Acute illness, oral temperature ≥37.5°C, or axillary lymphadenopathy on Study Day -84, Study Day 0, or Study Day 28.
- Any of the following laboratory results from blood and urine collected within 7 days prior to Study Day -84 (evaluated per local laboratory parameters):
- Abnormal hemoglobin or hematocrit
- Abnormal white blood cell count, absolute neutrophil count, or absolute lymphocyte count
- Elevated creatinine, total bilirubin, AST, ALT, or alkaline phosphatase (ALP)
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
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- Laboratory test (e.g., QuantiFERON®-TB) evidence of Mycobacterium tuberculosis (Mtb) infection
- History of residence in a tuberculosis-endemic country, per WHO 2008 "high-burden" definition
- History of treatment for active or latent tuberculosis infection
- History or evidence (including chest X-ray) of active tuberculosis
- Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
- History of allergic disease or reactions likely to be exacerbated by any component of the BCG or study vaccines
- History of autoimmune disease or immunosuppression
- Current household contact or occupational exposure to an individual with known significant immunosuppression
- History or evidence on physical examination of any systemic disease, or acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy
- History or laboratory evidence of any past, present or future possible immunodeficiency state which will include (but is not limited to) any laboratory indication of HIV infection
- History of alcohol or drug abuse within the past 2 years
- History of cheloid formation
- Previous medical history that may compromise the safety of the subject in the study
- Any current medical, psychiatric, occupational, or substance abuse problems which, in the opinion of the investigator, will make it unlikely the subject will comply with the protocol
- Inability to discontinue daily medications during the study period except the following:
- Contraceptives
- Multivitamins
- Inhaled or topical corticosteroids
- Tobacco smoking of a pack or more of cigarettes a day, or cannabis smoking three or more days per week
- Received immunosuppressive medication within 45 days prior to Study Day -84 (inhaled and topical corticosteroids are permitted)
- Received investigational drugs or vaccine products within 182 days prior to Study Day -84 or planned participation in any other investigational study during the study period
- Received investigational Mtb vaccine at any time prior to Study Day -84
- Received vaccination or immunotherapy with a BCG product at any time prior to Study Day -84.
- Received immunoglobulin or blood products within 45 days prior to Study Day -84.
- Received any standard vaccine within 45 days prior to Study Day -84 except inactivated influenza vaccine which may have been received within 2 weeks prior to Study Day -84.
- History of high risk sexual behaviors since 1977.
About this study
Official title: A Phase I, Double-Blind, Randomized, Placebo-controlled Leukapheresis Study to Obtain Lymphocytes for the Study of Immune Responses in Healthy Adult Volunteers in the U.S. Who Receive BCG Vaccination Followed by Boosting With AERAS-402
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days.
Read the detailed description
This was a double-blind, randomized, placebo-controlled study. At least 13, but no more than 16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG (1-8 x 105 colony forming units [CFU] intradermally [ID]) at Study Day -84. Thirteen of the BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to receive study vaccine (either AERAS-402 3 x 1010 virus particles [vp] intramuscularly [IM] or placebo IM) at Study Days 0 and 28, based on time of completion of screening. Eleven subjects were randomized (N=9 AERAS-402; N=2 placebo) and analyzed. Enrollment was stopped when 11 of the planned 13 subjects had been randomized, as it was felt that this number of subjects was sufficient to address the objectives of the study.
- Conditions
- Tuberculosis
- Being tested
- AERAS-402, Placebo, BCG (1-8 x105 cfu ID)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERAS-402Biological
Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).
PlaceboBiological
Identical buffer solution in which AERAS-402 is formulated.
BCG (1-8 x105 cfu ID)Biological
BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.
| Study group | Role | What they receive |
|---|---|---|
| AERAS-402 | Experimental | 3 x10^10 viral particles per 0.5 mL suspended in 10 mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL. Receives: Biological: AERAS-402; Biological: BCG (1-8 x105 cfu ID) |
| Placebo | Active comparator | 1.0 mL sterile vaccine buffer containing 10mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL Receives: Biological: Placebo; Biological: BCG (1-8 x105 cfu ID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular immune responses to AERAS-402 in healthy adult volunteers who received two booster doses of AERAS-402 administered 84 and 112 days after BCG vaccination, through leukapheresis and cryopreservation of cells followed by in vitro assay.
percentage of CD4 and CD8 T cells from leukapheresis that produce any of three cytokines (IFN γ, TNF α, and/or IL 2).
Measured: Up to study day 98
Secondary outcomes (1)
Evaluation of adverse events (AEs) and serious adverse events (SAEs).
Measured: Up to study day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann M Ginsberg, MD PhD, Study director, Aeras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375256
- Sponsor's protocol ID
- C-021-402
- Acronym
- C-021-402
- Status last verified
- Feb 2015
- First submitted
- 24 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Randomized, Placebo-controlled Leukapheresis Study to Obtain Lymphocytes for the Study of Immune Responses in Healthy Adult Volunteers in the U.S. Who Receive BCG Vaccination Followed by Boosting With AERAS-402
- ClinicalTrials.gov ID
- NCT02375256
- Acronym / sponsor ID
- C-021-402 / C-021-402
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days.
Detailed description
This was a double-blind, randomized, placebo-controlled study. At least 13, but no more than 16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG (1-8 x 105 colony forming units [CFU] intradermally [ID]) at Study Day -84. Thirteen of the BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to receive study vaccine (either AERAS-402 3 x 1010 virus particles [vp] intramuscularly [IM] or placebo IM) at Study Days 0 and 28, based on time of completion of screening. Eleven subjects were randomized (N=9 AERAS-402; N=2 placebo) and analyzed. Enrollment was stopped when 11 of the planned 13 subjects had been randomized, as it was felt that this number of subjects was sufficient to address the objectives of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AERAS-402 | Experimental | Biological: AERAS-402, Biological: BCG (1-8 x105 cfu ID)3 x10^10 viral particles per 0.5 mL suspended in 10 mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL. |
| Placebo | Active comparator | Biological: Placebo, Biological: BCG (1-8 x105 cfu ID)1.0 mL sterile vaccine buffer containing 10mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Is male or female
- Provided written informed consent prior to any study related procedures
- Is age ≥18 years and ≤45 years on Study Day -84.
- Has Body Mass Index (BMI) ≥19 and <33 by nomogram (see appendices)
- Has general good health, confirmed by medical history and physical examination
Key exclusion criteria (32 listed)
- Acute illness, oral temperature ≥37.5°C, or axillary lymphadenopathy on Study Day -84, Study Day 0, or Study Day 28.
- Any of the following laboratory results from blood and urine collected within 7 days prior to Study Day -84 (evaluated per local laboratory parameters):
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
- Laboratory test (e.g., QuantiFERON®-TB) evidence of Mycobacterium tuberculosis (Mtb) infection
- History of residence in a tuberculosis-endemic country, per WHO 2008 "high-burden" definition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AERAS-402Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4). | Biological | AERAS-402 |
| PlaceboIdentical buffer solution in which AERAS-402 is formulated. | Biological | Placebo |
| BCG (1-8 x105 cfu ID)BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo. | Biological | AERAS-402, Placebo |
Primary outcome
Cellular immune responses to AERAS-402 in healthy adult volunteers who received two booster doses of AERAS-402 administered 84 and 112 days after BCG vaccination, through leukapheresis and cryopreservation of cells followed by in vitro assay.
Time frame: Up to study day 98
percentage of CD4 and CD8 T cells from leukapheresis that produce any of three cytokines (IFN γ, TNF α, and/or IL 2).
1 secondary outcome
Evaluation of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Up to study day 98
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Ginsberg, MD PhD study director
Aeras
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AERAS-402 and BCG (1-8 x105 cfu ID) in people with Tuberculosis, run by Aeras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular immune responses to AERAS-402 in healthy adult volunteers who received two booster doses of AERAS-402 administered 84 and 112 days after BCG vaccination, through leukapheresis and cryopreservation of cells followed by in vitro assay. (time frame: Up to study day 98). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.