TuberculosisPhase 1NCT01340820
Study of AERAS 422 in Healthy Adults
A Phase 1 study testing AERAS-422 and BCG Tice in people with Tuberculosis, run by Aeras at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults. 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-422 and BCG Tice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 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
- -≥18 years and ≤45 years of age on randomization day
- Has general good health, confirmed by medical history and physical examination
- Has a screening body mass index (BMI) ≥19 and <33
- 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 use acceptable method of avoiding pregnancy from 28 days prior to randomization through the end of the study.
- Acceptable methods of avoiding pregnancy -Females physically capable of pregnancy must have:
- Negative urine pregnancy test within 21 days prior to randomization AND within 24 hours prior to Study Day 0 vaccination
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- Ability to complete all protocol study visits and be reachable by telephone
- Provided written informed consent prior to screening evaluations
- Completed simultaneous enrollment in the Aeras Vaccine Registry protocol
Who cannot join
- Acute illness on randomization day
- Oral temperature >=37.5 degrees C on randomization day
- Abnormal laboratory values from blood collected within 21 days prior to randomization as follows:
- Positive test for hepatitis B core antibody or hepatitis C antibody
- Positive test for HIV
- Positive urine test for opiates, cocaine, or amphetamines
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- Positive QuantiFERON®-TB Gold test
- History of treatment for active or latent tuberculosis infection
- Other evidence of active or latent tuberculosis, in the opinion of the investigator
- Tuberculin skin test (TST) within 90 days prior to randomization
- History or evidence of allergic disease or reaction that in the opinion of the investigator is likely to be exacerbated by any component of AERAS-422 or BCG Tice
- History or evidence of autoimmune disease, immunosuppression, or immunodeficiency, in the opinion of the investigator
- History or evidence of cheloid formation, axillary or cervical lymphadenopathy, or other dermatologic or anatomic findings that, in the opinion of the investigator, may interfere with the assessment of injection site reactions
- History or evidence of any other acute or chronic disease or condition that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the evaluation of the vaccine safety or immunogenicity
- Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely the subject will comply with the protocol
- Inability to discontinue daily prescription medications (except contraceptives) during the study.
- Received immunosuppressive medication within 45 days prior to randomization (inhaled and topical corticosteroids are permitted)
- Received investigational drugs or vaccine products within 182 days prior to randomization, or planned participation in any other investigational study during the study
- Received investigational Mtb vaccine at any time prior to randomization
- Received vaccination or immunotherapy with a BCG product at any time prior to randomization
- Received immunoglobulin or blood products within 45 days prior to randomization
- Received inactivated influenza vaccine within 14 days prior to randomization or any other standard vaccine within 45 days prior to randomization.
- Received systemic antibiotics within 14 days prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis University Hospital
St Louis, Missouri, 63104
About this study
Official title: A Phase 1, Randomized, Controlled, Double-blind, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of AERAS-422 in Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.
Read the detailed description
This is a Phase I, randomized, controlled, double-blind, dose-escalation study of AERAS-422. This study will be conducted in 24 HIV-negative, healthy adults who are BCG-naïve and negative for prior exposure to Mtb at enrollment. The study will be conducted at one or more clinical research sites in the United States.
AERAS-422 will be administered on Study Day 0 as a single 0.1 mL intradermal (ID) injection containing either >= 10^5 to <10^6 CFU (low-dose) or >=10^6 CFU (high-dose). BCG Tice® will be used as an active control for AERAS-422 and will be administered as a single 0.1 mL ID injection containing 1-8 x 10^5 CFU on Study Day 0.
- Conditions
- Tuberculosis
- Being tested
- AERAS-422, BCG Tice
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERAS-422Drug
Also called BCG Tice
rBCG
BCG TiceDrug
1-8 x 10^5 CFU
| Study group | Role | What they receive |
|---|---|---|
| AERAS-422 Low dose | Experimental | >=10^5 to < 10^6 CFU Receives: Drug: AERAS-422 |
| AERAS-422 High Dose | Experimental | >=10^6 CFU Receives: Drug: AERAS-422 |
| BCG Tice | Active comparator | BCG Tice 1-8 x 10^5 CFU Receives: Drug: BCG Tice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assessment of collected unsolicited and solicited adverse events (including site of injection reaction (pain, erythema, induration, ulceration, drainage, and scarring), regional lymphadenopathy (axillary and cervical), fever, headache, myalgia, arthralgia and fatigue. The adverse event collection timeframe includes all events that occur up to 56 days after study vaccination. Assessment of serious adverse events will be based on events collected throughout the duration of the study. All safety data will be evaluated before moving into the next successive dose level.
Measured: Days 0, 3, 7, 14, 28, 56, 84, 112, 140 & 182
Secondary outcomes (1)
Immunogenicity
Measurement of immunogenicity based on the percentage of cytokine producing T cells.
Measured: Days 0, 14, 28, 56, 84, 112, 140 and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionMay 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Hoft, MD, Principal investigator, St. Louis University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340820
- Sponsor's protocol ID
- C-007-422
- Status last verified
- Aug 2012
- First submitted
- 24 Feb 2011
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoft DF, Blazevic A, Selimovic A, Turan A, Tennant J, Abate G, Fulkerson J, Zak DE, Walker R, McClain B, Sadoff J, Scott J, Shepherd B, Ishmukhamedov J, Hokey DA, Dheenadhayalan V, Shankar S, Amon L, Navarro G, Podyminogin R, Aderem A, Barker L, Brennan M, Wallis RS, Gershon AA, Gershon MD, Steinberg S. Safety and Immunogenicity of the Recombinant BCG Vaccine AERAS-422 in Healthy BCG-naive Adults: A Randomized, Active-controlled, First-in-human Phase 1 Trial. EBioMedicine. 2016 May;7:278-86. doi: 10.1016/j.ebiom.2016.04.010. Epub 2016 Apr 19.
PubMed 27322481
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Controlled, Double-blind, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of AERAS-422 in Healthy Adults
- ClinicalTrials.gov ID
- NCT01340820
- Acronym / sponsor ID
- C-007-422
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Apr 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.
The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.
Detailed description
This is a Phase I, randomized, controlled, double-blind, dose-escalation study of AERAS-422. This study will be conducted in 24 HIV-negative, healthy adults who are BCG-naïve and negative for prior exposure to Mtb at enrollment. The study will be conducted at one or more clinical research sites in the United States.
AERAS-422 will be administered on Study Day 0 as a single 0.1 mL intradermal (ID) injection containing either >= 10^5 to <10^6 CFU (low-dose) or >=10^6 CFU (high-dose). BCG Tice® will be used as an active control for AERAS-422 and will be administered as a single 0.1 mL ID injection containing 1-8 x 10^5 CFU on Study Day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AERAS-422 Low dose | Experimental | Drug: AERAS-422>=10^5 to < 10^6 CFU |
| AERAS-422 High Dose | Experimental | Drug: AERAS-422>=10^6 CFU |
| BCG Tice | Active comparator | Drug: BCG TiceBCG Tice 1-8 x 10^5 CFU |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- -≥18 years and ≤45 years of age on randomization day
- Has general good health, confirmed by medical history and physical examination
- Has a screening body mass index (BMI) ≥19 and <33
- 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 use acceptable method of avoiding pregnancy from 28 days prior to randomization through the end of the study.
- Acceptable methods of avoiding pregnancy -Females physically capable of pregnancy must have:
Key exclusion criteria (23 listed)
- Acute illness on randomization day
- Oral temperature >=37.5 degrees C on randomization day
- Abnormal laboratory values from blood collected within 21 days prior to randomization as follows:
- Positive test for hepatitis B core antibody or hepatitis C antibody
- Positive test for HIV
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-422Also: BCG TicerBCG | Drug | AERAS-422 High Dose, AERAS-422 Low dose |
| BCG Tice1-8 x 10^5 CFU | Drug | BCG Tice |
Primary outcome
Safety
Time frame: Days 0, 3, 7, 14, 28, 56, 84, 112, 140 & 182
Assessment of collected unsolicited and solicited adverse events (including site of injection reaction (pain, erythema, induration, ulceration, drainage, and scarring), regional lymphadenopathy (axillary and cervical), fever, headache, myalgia, arthralgia and fatigue. The adverse event collection timeframe includes all events that occur up to 56 days after study vaccination. Assessment of serious adverse events will be based on events collected throughout the duration of the study. All safety data will be evaluated before moving into the next successive dose level.
1 secondary outcome
Immunogenicity
Time frame: Days 0, 14, 28, 56, 84, 112, 140 and 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 16 Aug 2012.
- Derived from this study: PubMed 27322481Hoft DF, Blazevic A, Selimovic A, Turan A, Tennant J, Abate G, Fulkerson J, Zak DE, Walker R, McClain B, Sadoff J, Scott J, Shepherd B, Ishmukhamedov J, Hokey DA, Dheenadhayalan V, Shankar S, Amon L, Navarro G, Podyminogin R, Aderem A, Barker L, Brennan M, Wallis RS, Gershon AA, Gershon MD, Steinberg S. Safety and Immunogenicity of the Recombinant BCG Vaccine AERAS-422 in Healthy BCG-naive Adults: A Randomized, Active-controlled, First-in-human Phase 1 Trial. EBioMedicine. 2016 May;7:278-86. doi: 10.1016/j.ebiom.2016.04.010. Epub 2016 Apr 19.
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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.
Daniel Hoft, MD principal investigator
St. Louis University Hospital
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-422 and BCG Tice in people with Tuberculosis, run by Aeras at 1 site in United States.
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 23 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 16 Aug 2012. 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 United States. 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. 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?
Safety (time frame: Days 0, 3, 7, 14, 28, 56, 84, 112, 140 & 182). 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 NCT01340820, 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 16 Aug 2012.