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

NCT02375256 | Completed Phase 1

• 1 other identifier: C-021-402
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (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.

  percentage of CD4 and CD8 T cells from leukapheresis that produce any of three cytokines (IFN γ, TNF α, and/or IL 2).

  Up to study day 98

Secondary Outcomes (1)

• Evaluation of adverse events (AEs) and serious adverse events (SAEs).

  Up to study day 98

Study Arms (2)

AERAS-402

EXPERIMENTAL

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; Biological: BCG (1-8 x105 cfu ID)

Placebo

ACTIVE COMPARATOR

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; Biological: BCG (1-8 x105 cfu ID)

Interventions

AERAS-402 BIOLOGICAL

Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).

AERAS-402

Placebo BIOLOGICAL

Identical buffer solution in which AERAS-402 is formulated.

Placebo

BCG (1-8 x105 cfu ID) BIOLOGICAL

BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.

AERAS-402; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is male or female
• Provided written informed consent prior to any study related procedures
• Is age ≥18 years and ≤45 years on Study Day -84.
• Has Body Mass Index (BMI) ≥19 and \<33 by nomogram (see appendices)
• Has general good health, confirmed by medical history and physical examination
• 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.
• 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.
• Has committed to avoid elective surgery for the duration of the study
• Has ability to complete all study visits as required per the protocol and is able to be contacted by telephone

You may not qualify if:

• Acute illness, oral temperature ≥37.5°C, or axillary lymphadenopathy on Study Day -84, Study Day 0, or Study Day 28.
• 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)
• Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other)
• Laboratory test (e.g., QuantiFERON®-TB) evidence of Mycobacterium tuberculosis (Mtb) infection
• History of residence in a tuberculosis-endemic country, per WHO 2008 "high-burden" definition
• History of treatment for active or latent tuberculosis infection
• 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
• History of allergic disease or reactions likely to be exacerbated by any component of the BCG or study vaccines
• History of autoimmune disease or immunosuppression
• Current household contact or occupational exposure to an individual with known significant immunosuppression
• 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

Sponsors & Collaborators

• Aeras: lead

MeSH Terms

Conditions

Tuberculosis

Interventions

AERAS-402

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Ann M Ginsberg, MD PhD

  Aeras

  STUDY DIRECTOR

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 24, 2015
• First Posted: March 2, 2015
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2013
• Last Updated: March 3, 2015

Record last verified: 2015-02