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
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedFebruary 19, 2014
February 1, 2014
1.5 years
February 17, 2014
February 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Evaluate the immunogenicity of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant.
all subjects will have immunology samples taken at 9 time points over 182 days
Study Arms (8)
AERAS-404(50mcg H4/0nmol IC31) or Placebo
EXPERIMENTAL1 dose
AERAS404 (50mcgH4/100nmol IC31) or Placebo
EXPERIMENTAL1 dose
AERAS404 (50mcgH4/0nmol IC31) or Placebo
EXPERIMENTAL2 dose
AERAS404 (150mcgH4/0nmol IC31) or Placebo
EXPERIMENTAL1 dose
AERAS404 (50mcgH4/5000nmol IC31) or Placebo
EXPERIMENTAL1 dose
AERAS404 (50mcgH4/500nmol IC31) or Placebo
EXPERIMENTAL2 dose
AERAS404
EXPERIMENTAL2 dose placebo
AERAS404 (50mcg H4/100nmol IC31) or Placebo
EXPERIMENTAL2 dose
Interventions
AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.
Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aeraslead
- Statens Serum Institutcollaborator
Study Sites (1)
Karolinska Institutet, Karolinska University Hospital
Huddinge, Stockholm County, 14186, Sweden
Related Publications (1)
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.
PMID: 28216183DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhongkai SHI, MD
Aeras
- PRINCIPAL INVESTIGATOR
Jan Andersson, MD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
November 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 19, 2014
Record last verified: 2014-02