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TuberculosisPhase 1NCT02066428

A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection

A Phase 1 study testing AERAS-404 in people with Tuberculosis, run by Aeras at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteSweden
Study dates
Nov 2007to May 2009
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

  • Male or female
  • Age 18 through 50 years on Study Day 0
  • Completed wriiten Informed Consent
  • BCG vaccination at least 5 years ago,
  • General good health, confirmed by medical history
  • (BMI) between 19 and 33 (kg/m2)
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  • Has ability to complete follow-up period of 182 days as required
  • Females must be physically incapable of conception
  • Avoiding elective surgery for the duration of the study
  • Stay in contact with the investigative site for the duration of the study
  • Complete simultaneous enrollment in Aeras Vaccine Development Registry protocol

Who cannot join

  • Acute illness on the day of randomization
  • Oral temperature >=37.5 degree Celcius 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 before entry into the study
  • Received any investigational drug therapy or investigational vaccine within 182 days
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  • Received inactivated influenza vaccine or inactivated tick-borne encephalitis vaccine within 14 days before entry into the study.
  • Current chronic drug therapy including hormone replacement such as thyroxin, insulin, etc.
  • History or laboratory evidence of any past, present or future possible immunodeficiency state which will include any laboratory indication of virus type 1 (HIV-1) infection
  • History of allergic disease or reactions, including eczema.
  • Previous medical history that may compromise safety of subject
  • Evidence of new acute illness that may compromise safety of subject
  • Evidence of chronic hepatitis
  • Inability to discontinue daily medication except contraception
  • History of alcohol or drug abuse within 2yrs
  • Tobacco or cannabis smoking three
  • Positive urine test for illicit drugs
  • History or evidence of any systemic disease on physical examination
  • History of active TB
  • Shared residence within 1 year with an individual on anti-TB treatment
  • All females: nursing
  • Abnormal hemoglobin,hematocrit etc drawn within 36 hours prior to randomization
  • Laboratory test evidence of Mtb infection
  • History of positive tuberculin skin test within past 10 years
  • Received a tuberculin skin test within 3 years
  • History of autoimmune disease

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet, Karolinska University Hospital

    Huddinge, Stockholm County, 14186

Other trials in Sweden

About this study

Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.

Read the detailed description

This ia a Phase I, randomized, placebo-controlled, double-blind study in three groups of healthy adult males or sterile females who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection.

Sixty-four subjects assigned to one of eight treatment groups to receive one of four different antigen/adjuvant combinations of study vaccine, or placebo control. Within each study group, subjects will be randomized to receive either a single-dose antigen/adjuvant regimen of study vaccine (vaccination with study vaccine on Study Day 0 followed by vaccination with placebo control on Study Day 56) or a two-dose antigen/adjuvant regimen of study vaccine (vaccination with study vaccine on Study Days 0 and 56).

All subjects will be followed for safety and immunogenicity evaluations for 182 days.

The sample sizes specified for each study group were selected because they are judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I study rather than for statistical reasons. If no SAE are observed among 56 subjects receiving active study vaccine, an approximation to the upper 95% confidence bound on the rate of SAE occurrence would be 5.4%.

Conditions
Tuberculosis
Being tested
AERAS-404, Placebo
Keywords
BCG Vaccinated, HIV Negative
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AERAS-404Biological

    Also called H4

    AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.

  • PlaceboBiological

    Also called Tris Buffered saline

    Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)

Study groups in NCT02066428
Study groupRoleWhat they receive
AERAS-404(50mcg H4/0nmol IC31) or PlaceboExperimental1 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404 (50mcgH4/100nmol IC31) or PlaceboExperimental1 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404 (50mcgH4/0nmol IC31) or PlaceboExperimental2 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404 (150mcgH4/0nmol IC31) or PlaceboExperimental1 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404 (50mcgH4/5000nmol IC31) or PlaceboExperimental1 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404 (50mcgH4/500nmol IC31) or PlaceboExperimental2 dose
Receives: Biological: AERAS-404; Biological: Placebo
AERAS404Experimental2 dose placebo
Receives: Biological: Placebo
AERAS404 (50mcg H4/100nmol IC31) or PlaceboExperimental2 dose
Receives: Biological: AERAS-404; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant

    Serious adverse events (SAE) will be collected on subjects throughout their participation in the study. Solicited and unsolicited AEs will be collected through 28 days after each vaccination.The safety profile of the different antigen/adjuvant treatment regimens will be described. Listings will be provided for all subjects with serious adverse events (SAE). All adverse events and clinically relevant laboratory results will be summarized across time points to examine the relationship between treatment regimens (i.e., number of doses and level of antigen/adjuvant) and key safety endpoints including number (percentage) of solicited and spontaneous adverse events and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria. Adverse events will also be summarized by severity and relationship to study vaccine by treatment regimen.

    Measured: 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

Secondary outcomes (1)

  1. Evaluate the immunogenicity of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant.

    Assessment of immune response will be based on the percentage of CD4 and CD8 T cells producing any of three cytokines (interferon gamma, IFN-γ; tumor necrosis factor alpha, TNF-α; and/or interleukin-2, IL-2) or any combination of these three cytokines simultaneously in response to stimulation with two the antigenic peptide pools contains 85B and TB10.4 representing the entire amino acid sequences of mycobacterial antigens Ag85B and TB10.4, respectively. Responses will be measured by flow cytometry using a qualified intracellular cytokine staining (ICS) assay

    Measured: all subjects will have immunology samples taken at 9 time points over 182 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2014 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02066428
Sponsor's protocol ID
C-005-404
Status last verified
Feb 2014
First submitted
17 Feb 2014
Last updated
19 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Norrby M, Vesikari T, Lindqvist L, Maeurer M, Ahmed R, Mahdavifar S, Bennett S, McClain JB, Shepherd BM, Li D, Hokey DA, Kromann I, Hoff ST, Andersen P, de Visser AW, Joosten SA, Ottenhoff THM, Andersson J, Brighenti S. Safety and immunogenicity of the novel H4:IC31 tuberculosis vaccine candidate in BCG-vaccinated adults: Two phase I dose escalation trials. Vaccine. 2017 Mar 14;35(12):1652-1661. doi: 10.1016/j.vaccine.2017.01.055. Epub 2017 Feb 17.

    PubMed 28216183

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AERAS-404 in people with Tuberculosis, run by Aeras at 1 site in Sweden.

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 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 19 Feb 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 Sweden. 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?

Evaluate the safety of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant (time frame: 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). 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 NCT02066428, 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 19 Feb 2014.

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Clinical Trial NCT02066428 | AzTrials