TuberculosisPhase 1NCT01378312
A Study to Evaluate Safety and Immunogenicity of AERAS-402
A Phase 1 study testing AERAS 402 in people with Tuberculosis, run by Aeras at 1 site in India.
Trial summary
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Mar 2012
- 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
- Is age 18 through 45 years on Study Day 0
- Has completed written informed consent
- Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
- Has general good health, confirmed by medical history and physical examination
- Has Body Mass Index (BMI) between 19 and 30 (kg/m2)
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- Has ability to complete follow-up period of 182 days as required by the protocol
- Females: Ability to avoid pregnancy from 28-days prior to initial study vaccination through the duration of their participation in the study.
- Will commit to avoiding elective surgery for the duration of the study
- Has ability to stay in contact with the investigative site for the duration of the study
- Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol
Who cannot join
- Acute illness on the day of randomization
- Oral temperature ≥37.5°C on the day of randomization
- Evidence of significant active infection
- Used immunosuppressive medication within 42 days before entry into the study
- Received immunoglobulin or blood products within 42 days
- Received any investigational drug therapy or vaccine within 182 days
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- Received any standard vaccine within 42 days
- Participated in any clinical trial of an investigational adenovirus-based vaccine previously.
- Current chronic drug therapy
- 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 allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous medical history that may compromise the safety of the subject in the study
- Evidence of a new acute illness that may compromise the safety of the subject in the study
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
- Inability to discontinue daily medications except contraceptives during the study period
- History of alcohol or drug abuse within the past 2 years
- Tobacco or cannabis smoking three or more days per week
- Positive urine test for illicit drugs (opiates, cocaine, amphetamines)
- History or evidence of any systemic disease on physical examination
- 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
- All females: Positive urine pregnancy test during screening; positive serum pregnancy test on the day of study vaccination; are nursing
- Abnormal (per local laboratory parameters) hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, absolute lymphocyte count, prothrombin time (PT), partial thromboplastin time (PTT), serum creatinine, GGT, ALT, AST, total bilirubin, alkaline phosphatase (ALP), or creatinine drawn within 36 hours prior to randomization.
- Laboratory test evidence of Mtb infection
- Tuberculin skin test evidence of Mtb infection, defined as 15 mm of induration or greater.
- Anal intercourse with another man at least one time (with or without condoms)
- Exchange of goods, money, services or drugs for sex.
- Use of intravenous drugs.
- Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual
- Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs
- Oral to genital contact within the last 12 months with a known user of intravenous drug
- Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner
- Oral to genital contact within the last 12 months with an individual known to have more than one sex partner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India.
The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.
- Conditions
- Tuberculosis
- Being tested
- AERAS 402, Placebo
- Keywords
- vaccine, TB, tuberculosis
- 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
0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28
PlaceboBiological
0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Not described Receives: Biological: Placebo |
| AERAS 402 Arm | Active comparator | Not described Receives: Biological: AERAS 402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Adverse Events by treatment group
The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
Measured: Day 56
Secondary outcomes (1)
Immune Response
Percentage of CD4 and CD8 cells producing specific cytokines will be measured and tabulated in subjects who have received the vaccine.
Measured: Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanya Dhagat, MD, Principal investigator, Lotus Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378312
- Sponsor's protocol ID
- C-004-402
- Status last verified
- Nov 2012
- First submitted
- 24 Feb 2011
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoft DF, Blazevic A, Stanley J, Landry B, Sizemore D, Kpamegan E, Gearhart J, Scott A, Kik S, Pau MG, Goudsmit J, McClain JB, Sadoff J. A recombinant adenovirus expressing immunodominant TB antigens can significantly enhance BCG-induced human immunity. Vaccine. 2012 Mar 9;30(12):2098-108. doi: 10.1016/j.vaccine.2012.01.048. Epub 2012 Jan 30.
PubMed 22296955
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT01378312
- Acronym / sponsor ID
- C-004-402
- Conditions
- Tuberculosis
- Keywords
- vaccine, TB, tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Jun 2011 (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.
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India.
The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.
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 |
|---|---|---|
| Placebo Arm | Placebo comparator | Biological: Placebo |
| AERAS 402 Arm | Active comparator | Biological: AERAS 402 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is male or female
- Is age 18 through 45 years on Study Day 0
- Has completed written informed consent
- Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
- Has general good health, confirmed by medical history and physical examination
Key exclusion criteria (33 listed)
- Acute illness on the day of randomization
- Oral temperature ≥37.5°C on the day of randomization
- Evidence of significant active infection
- Used immunosuppressive medication within 42 days before entry into the study
- Received immunoglobulin or blood products within 42 days
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 4020.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28 | Biological | AERAS 402 Arm |
| Placebo0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28 | Biological | Placebo Arm |
Primary outcome
Number and Percentage of Adverse Events by treatment group
Time frame: Day 56
The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
1 secondary outcome
Immune Response
Time frame: Day 182
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 17 Mar 2014.
- Derived from this study: PubMed 22296955Hoft DF, Blazevic A, Stanley J, Landry B, Sizemore D, Kpamegan E, Gearhart J, Scott A, Kik S, Pau MG, Goudsmit J, McClain JB, Sadoff J. A recombinant adenovirus expressing immunodominant TB antigens can significantly enhance BCG-induced human immunity. Vaccine. 2012 Mar 9;30(12):2098-108. doi: 10.1016/j.vaccine.2012.01.048. Epub 2012 Jan 30.
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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.
Vanya Dhagat, MD principal investigator
Lotus Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AERAS 402 in people with Tuberculosis, run by Aeras at 1 site in India.
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 11 inclusion and 33 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 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Number and Percentage of Adverse Events by treatment group (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378312, which also lists 1 linked publication.
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 17 Mar 2014.