Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402 (C-021-402)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375256
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Aeras

Brief Summary:
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: AERAS-402 Biological: Placebo Biological: BCG (1-8 x105 cfu ID) Phase 1

Detailed Description:
This was a double-blind, randomized, placebo-controlled study. At least 13, but no more than 16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG (1-8 x 105 colony forming units [CFU] intradermally [ID]) at Study Day -84. Thirteen of the BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to receive study vaccine (either AERAS-402 3 x 1010 virus particles [vp] intramuscularly [IM] or placebo IM) at Study Days 0 and 28, based on time of completion of screening. Eleven subjects were randomized (N=9 AERAS-402; N=2 placebo) and analyzed. Enrollment was stopped when 11 of the planned 13 subjects had been randomized, as it was felt that this number of subjects was sufficient to address the objectives of the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Double-Blind, Randomized, Placebo-controlled Leukapheresis Study to Obtain Lymphocytes for the Study of Immune Responses in Healthy Adult Volunteers in the U.S. Who Receive BCG Vaccination Followed by Boosting With AERAS-402
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: AERAS-402
3 x10^10 viral particles per 0.5 mL suspended in 10 mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL.
Biological: AERAS-402
Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).

Biological: BCG (1-8 x105 cfu ID)
BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.

Active Comparator: Placebo
1.0 mL sterile vaccine buffer containing 10mM Tris buffer, 1 mM MgCl2, 75 mM NaCl, 5% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80), 0.1 mM EDTA, 10 mM l-histidine, 0.5% v/v ethanol and water. The dose volume administered was 0.5 mL
Biological: Placebo
Identical buffer solution in which AERAS-402 is formulated.

Biological: BCG (1-8 x105 cfu ID)
BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.




Primary Outcome Measures :
  1. Cellular immune responses to AERAS-402 in healthy adult volunteers who received two booster doses of AERAS-402 administered 84 and 112 days after BCG vaccination, through leukapheresis and cryopreservation of cells followed by in vitro assay. [ Time Frame: Up to study day 98 ]
    percentage of CD4 and CD8 T cells from leukapheresis that produce any of three cytokines (IFN γ, TNF α, and/or IL 2).


Secondary Outcome Measures :
  1. Evaluation of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Up to study day 98 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is male or female
  2. Provided written informed consent prior to any study related procedures
  3. Is age ≥18 years and ≤45 years on Study Day -84.
  4. Has Body Mass Index (BMI) ≥19 and <33 by nomogram (see appendices)
  5. Has general good health, confirmed by medical history and physical examination
  6. 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 avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to Study Day -84 through the end of the study.
  7. Females physically capable of pregnancy must have a negative serum pregnancy test within 7 days prior to Study Day -84 AND a negative urine pregnancy test on Study Day -84, Study Day 0, and Study Day 28.
  8. Has committed to avoid elective surgery for the duration of the study
  9. Has ability to complete all study visits as required per the protocol and is able to be contacted by telephone

Exclusion Criteria:

  1. Acute illness, oral temperature ≥37.5°C, or axillary lymphadenopathy on Study Day -84, Study Day 0, or Study Day 28.
  2. Any of the following laboratory results from blood and urine collected within 7 days prior to Study Day -84 (evaluated per local laboratory parameters):

    • Abnormal hemoglobin or hematocrit
    • Abnormal white blood cell count, absolute neutrophil count, or absolute lymphocyte count
    • Elevated creatinine, total bilirubin, AST, ALT, or alkaline phosphatase (ALP)
  3. Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
  4. Laboratory test (e.g., QuantiFERON®-TB) evidence of Mycobacterium tuberculosis (Mtb) infection
  5. History of residence in a tuberculosis-endemic country, per WHO 2008 "high-burden" definition
  6. History of treatment for active or latent tuberculosis infection
  7. History or evidence (including chest X-ray) of active tuberculosis
  8. Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
  9. History of allergic disease or reactions likely to be exacerbated by any component of the BCG or study vaccines
  10. History of autoimmune disease or immunosuppression
  11. Current household contact or occupational exposure to an individual with known significant immunosuppression
  12. History or evidence on physical examination of any systemic disease, or acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy
  13. 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
  14. History of alcohol or drug abuse within the past 2 years
  15. History of cheloid formation
  16. Previous medical history that may compromise the safety of the subject in the study
  17. Any current medical, psychiatric, occupational, or substance abuse problems which, in the opinion of the investigator, will make it unlikely the subject will comply with the protocol
  18. Inability to discontinue daily medications during the study period except the following:

    • Contraceptives
    • Multivitamins
    • Inhaled or topical corticosteroids
  19. Tobacco smoking of a pack or more of cigarettes a day, or cannabis smoking three or more days per week
  20. Received immunosuppressive medication within 45 days prior to Study Day -84 (inhaled and topical corticosteroids are permitted)
  21. Received investigational drugs or vaccine products within 182 days prior to Study Day -84 or planned participation in any other investigational study during the study period
  22. Received investigational Mtb vaccine at any time prior to Study Day -84
  23. Received vaccination or immunotherapy with a BCG product at any time prior to Study Day -84.
  24. Received immunoglobulin or blood products within 45 days prior to Study Day -84.
  25. Received any standard vaccine within 45 days prior to Study Day -84 except inactivated influenza vaccine which may have been received within 2 weeks prior to Study Day -84.
  26. History of high risk sexual behaviors since 1977.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375256


Sponsors and Collaborators
Aeras
Investigators
Layout table for investigator information
Study Director: Ann M Ginsberg, MD PhD Aeras
Layout table for additonal information
Responsible Party: Aeras
ClinicalTrials.gov Identifier: NCT02375256    
Other Study ID Numbers: C-021-402
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections