TuberculosisPhase 1C-011-404NCT02109874
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404)
A Phase 1 study testing AERAS-404 (mcg H4/nmol IC31) and Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl in people with Tuberculosis, run by Aeras at 1 site in South Africa.
Trial summary
This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- AERAS-404 (mcg H4/nmol IC31) and Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Africa
- Study dates
- Dec 2008to Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have met all of the following criteria:
- Had completed written informed consent
- Was male or female
- Was age 18 through 50 years on Study Day 0
- Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
- Had general good health, confirmed by medical history and physical examination
Show all 12Show fewer
- Had a Body Mass Index (BMI) between 19 and 33 (weight in kg/[height in m]2)
- Agreed to complete a follow-up period of 182 days as required by the protocol
- Females: Agreed to avoid pregnancy from 28 days prior to Study Day 0 through the follow-up period of 182 days.
- Agreed to avoid elective surgery for the duration of the study
- Agreed to stay in contact with the investigative site for the duration of the study
- Had completed simultaneous enrollment in Aeras Vaccine Development Registry protocol
Who cannot join
- Subjects must not have:
- Acute illness on Study Day 0
- Oral temperature equal to or greater than 37.5 degrees C on Study Day 0
- Evidence of significant active infection
- Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted)
- Received immunoglobulin or blood products within 42 days before Study Day 0
Show all 26Show fewer
- Received any investigational drug therapy or investigational vaccine within 182 days before Study Day 0
- Received inactivated influenza vaccine or inactivated tick-borne encephalitis vaccine within 14 days before entry into the study, or any other standard vaccine within 42 days before Study Day 0 (the use of licensed drugs or vaccines medically indicated during the study interval was permitted)
- Current chronic drug therapy including hormone replacement such as thyroxin, insulin, etc. Estrogen and progesterone replacement and contraceptives were acceptable.
- History or laboratory evidence of any past, present or future possible immunodeficiency state which included (but was not limited to) any laboratory indication of HIV infection
- History of allergic disease or reactions, including eczema, likely to be exacerbated by any component of the study vaccine
- Previous medical history that may have compromised the safety of the subject in the study
- Evidence of a new acute illness that may have compromised the safety of the subject in the study
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody or hepatitis C antibody)
- 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 3 or more days per week
- Positive urine test for illicit drugs (opiates, cocaine, amphetamines)
- History or evidence of any systemic disease on physical examination or any acute or chronic illness that, in the opinion of the investigator, may have interfered with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy
- 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; were nursing
- Abnormal (per local laboratory parameters) chemistry, hematology or urinalysis obtained within 36 hours prior to randomization.
- Laboratory evidence of Mtb infection, defined as a positive QuantiFERON-TB Gold (QFT-G) test.
- History of a positive tuberculin skin test within the past ten years (defined according to local guidelines).
- Received a tuberculin skin test within 3 months (90 days) prior to Study Day 0.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Tuberculosis Vaccine Institute; Brewelskloof Hospital
Worcester
About this study
Official title: A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS 404 When Administered as a Single Adjuvant Amount With Different Antigen Amounts in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will be conducted at one or two sites located in South Africa. The purpose is to evaluate the safety and immunogenicity of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection.
Read the detailed description
This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will be conducted at one or two sites located in South Africa.
Forty subjects will be sequentially enrolled into one of four study groups (i.e., Group 1, Group 2, Group 3, or Group 4) based on time of completion of screening, with 10 subjects enrolled into each group. Within each study group, subjects will be randomized to a treatment regimen of either AERAS-404 or placebo control administered by intramuscular injection on Study Day 0 and Study Day 56. All subjects will receive the same treatment on Study Day 0 as they receive on Study Day 56. The dose of antigen will increase between study groups. All subjects will be followed for safety and immunogenicity evaluations for 182 days. A total of eleven clinic visits are planned (excluding screening) for all subjects.
- Conditions
- Tuberculosis
- Being tested
- AERAS-404 (mcg H4/nmol IC31), Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERAS-404 (mcg H4/nmol IC31)Biological
Also called H4, AERAS-404
Dose escalation
Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaClBiological
| Study group | Role | What they receive |
|---|---|---|
| AERAS-404 (mcg H4/nmol IC31) 5/500 | Experimental | H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol
IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl Receives: Biological: AERAS-404 (mcg H4/nmol IC31) |
| AERAS-404 (mcg H4/nmol IC31) 15/500 | Experimental | H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol
IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl Receives: Biological: AERAS-404 (mcg H4/nmol IC31) |
| AERAS-404 (mcg H4/nmol IC31) 50/500 | Experimental | H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol
IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl Receives: Biological: AERAS-404 (mcg H4/nmol IC31) |
| AERAS-404 (mcg H4/nmol IC31) 150/500 | Experimental | H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol
IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl Receives: Biological: AERAS-404 (mcg H4/nmol IC31) |
| Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl | Placebo comparator | Placebo: Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl. This is the identical buffer solution in which IC31 is formulated. Receives: Biological: Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult subjects. Safety will be measured by number (percentage) and severity of SAEs.
The safety profile will be described by treatment regimen. Serious adverse events (SAE) will be collected on subjects throughout their participation in the study. Solicited and unsolicited adverse events will be captured for 28 days after each vaccination. The number (percentage) of subjects with any adverse events (including solicited, unsolicited and serious adverse events) will be summarized by MedRA system organ class (SOC) and preferred term (PT). Additional summaries will present the number (percentage) of subjects with any adverse events by severity and by relationship to study vaccine. The number (percentage) of subjects with post-vaccination clinical laboratory values or vital sign values recorded as newly abnormal following study vaccination and meeting toxicity criteria will be tabulated at each post-vaccination point and overall.
Measured: Solicited and unsolicited AEs until study day 182
Secondary outcomes (1)
Evaluate the immunogenicity of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult subjects. Immune response will be based on percentage of CD4+ and CD8+ cells.
The primary response will be measured by flow cytometry in the Intracellular cytokine staining (ICS) assay. Immune responses will be based on percentage of CD4+ and CD8+ T cells that produced one, two, or three cytokines (IFN-gamma, TNF, and/or IL-2) in response to stimulation with one of the 2 antigenic peptide pool (Ag85B and TB10.4) derived from and representing the entire amino acid sequences of teh mycobacterial antigens Ag85B and TB10.4.
Measured: 182 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionSep 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor
- Investigators
- Zhongkai Shi, MD, Study director, Aeras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109874
- Sponsor's protocol ID
- C-011-404
- Acronym
- C-011-404
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Geldenhuys H, Mearns H, Miles DJ, Tameris M, Hokey D, Shi Z, Bennett S, Andersen P, Kromann I, Hoff ST, Hanekom WA, Mahomed H, Hatherill M, Scriba TJ; H4:IC31 Trial Study Group; van Rooyen M, Bruce McClain J, Ryall R, de Bruyn G; H4:IC31 Trial Study Groupa. The tuberculosis vaccine H4:IC31 is safe and induces a persistent polyfunctional CD4 T cell response in South African adults: A randomized controlled trial. Vaccine. 2015 Jul 9;33(30):3592-9. doi: 10.1016/j.vaccine.2015.05.036. Epub 2015 Jun 3.
PubMed 26048780
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. 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 404 When Administered as a Single Adjuvant Amount With Different Antigen Amounts in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT02109874
- Acronym / sponsor ID
- C-011-404 / C-011-404
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Apr 2014 (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, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will be conducted at one or two sites located in South Africa. The purpose is to evaluate the safety and immunogenicity of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection.
Detailed description
This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will be conducted at one or two sites located in South Africa.
Forty subjects will be sequentially enrolled into one of four study groups (i.e., Group 1, Group 2, Group 3, or Group 4) based on time of completion of screening, with 10 subjects enrolled into each group. Within each study group, subjects will be randomized to a treatment regimen of either AERAS-404 or placebo control administered by intramuscular injection on Study Day 0 and Study Day 56. All subjects will receive the same treatment on Study Day 0 as they receive on Study Day 56. The dose of antigen will increase between study groups. All subjects will be followed for safety and immunogenicity evaluations for 182 days. A total of eleven clinic visits are planned (excluding screening) for all subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AERAS-404 (mcg H4/nmol IC31) 5/500 | Experimental | Biological: AERAS-404 (mcg H4/nmol IC31)H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl |
| AERAS-404 (mcg H4/nmol IC31) 15/500 | Experimental | Biological: AERAS-404 (mcg H4/nmol IC31)H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl |
| AERAS-404 (mcg H4/nmol IC31) 50/500 | Experimental | Biological: AERAS-404 (mcg H4/nmol IC31)H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl |
| AERAS-404 (mcg H4/nmol IC31) 150/500 | Experimental | Biological: AERAS-404 (mcg H4/nmol IC31)H4 antigen (supplied in 4 different concentrations): 1.0 mL containing H4 antigen at 50, 150, 500, or 1500 mcg/mL in 10 mmol/L tris and 5% glycerol IC31 Adjuvant (supplied in 1 concentration): 0.8 mL containing IC31 adjuvant at 1250 nmol/mL, in 10 mmol/L tris and 169 mmol/L NaCl |
| Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl | Placebo comparator | Biological: Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaClPlacebo: Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl. This is the identical buffer solution in which IC31 is formulated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Had completed written informed consent
- Was male or female
- Was age 18 through 50 years on Study Day 0
- Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
- Had general good health, confirmed by medical history and physical examination
Key exclusion criteria (26 listed)
- Acute illness on Study Day 0
- Oral temperature equal to or greater than 37.5 degrees C on Study Day 0
- Evidence of significant active infection
- Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted)
- Received immunoglobulin or blood products within 42 days before Study Day 0
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-404 (mcg H4/nmol IC31)Also: H4, AERAS-404Dose escalation | Biological | AERAS-404 (mcg H4/nmol IC31) 15/500, AERAS-404 (mcg H4/nmol IC31) 150/500, AERAS-404 (mcg H4/nmol IC31) 5/500, AERAS-404 (mcg H4/nmol IC31) 50/500 |
| Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl | Biological | Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl |
Primary outcome
Evaluate the safety of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult subjects. Safety will be measured by number (percentage) and severity of SAEs.
Time frame: Solicited and unsolicited AEs until study day 182
The safety profile will be described by treatment regimen. Serious adverse events (SAE) will be collected on subjects throughout their participation in the study. Solicited and unsolicited adverse events will be captured for 28 days after each vaccination. The number (percentage) of subjects with any adverse events (including solicited, unsolicited and serious adverse events) will be summarized by MedRA system organ class (SOC) and preferred term (PT). Additional summaries will present the number (percentage) of subjects with any adverse events by severity and by relationship to study vaccine. The number (percentage) of subjects with post-vaccination clinical laboratory values or vital sign values recorded as newly abnormal following study vaccination and meeting toxicity criteria will be tabulated at each post-vaccination point and overall.
1 secondary outcome
Evaluate the immunogenicity of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult subjects. Immune response will be based on percentage of CD4+ and CD8+ cells.
Time frame: 182 days
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 27 Apr 2016.
- Background: PubMed 26048780Geldenhuys H, Mearns H, Miles DJ, Tameris M, Hokey D, Shi Z, Bennett S, Andersen P, Kromann I, Hoff ST, Hanekom WA, Mahomed H, Hatherill M, Scriba TJ; H4:IC31 Trial Study Group; van Rooyen M, Bruce McClain J, Ryall R, de Bruyn G; H4:IC31 Trial Study Groupa. The tuberculosis vaccine H4:IC31 is safe and induces a persistent polyfunctional CD4 T cell response in South African adults: A randomized controlled trial. Vaccine. 2015 Jul 9;33(30):3592-9. doi: 10.1016/j.vaccine.2015.05.036. Epub 2015 Jun 3.
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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.
Zhongkai Shi, MD study director
Aeras
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-404 (mcg H4/nmol IC31) and Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl in people with Tuberculosis, run by Aeras at 1 site in South Africa.
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 12 inclusion and 26 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 27 Apr 2016. 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 South Africa. 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?
Evaluate the safety of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult subjects. Safety will be measured by number (percentage) and severity of SAEs. (time frame: Solicited and unsolicited AEs until study day 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 NCT02109874, 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 27 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.