A Study to Evaluate Safety and Immunogenicity of AERAS-402

Tracking Information
First Submitted Date ICMJE	February 24, 2011
First Posted Date ICMJE	June 22, 2011
Last Update Posted Date	March 17, 2014
Study Start Date ICMJE	February 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 21, 2011)	Number and Percentage of Adverse Events by treatment group [ Time Frame: Day 56 ]; The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01378312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 21, 2011)	Immune Response [ Time Frame: Day 182 ]; Percentage of CD4 and CD8 cells producing specific cytokines will be measured and tabulated in subjects who have received the vaccine.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate Safety and Immunogenicity of AERAS-402
Official Title ICMJE	A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Brief Summary	This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India. The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Tuberculosis
Intervention ICMJE	Biological: AERAS 402 0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28; Biological: Placebo 0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
Study Arms	Placebo Comparator: Placebo Arm Intervention: Biological: Placebo; Active Comparator: AERAS 402 Arm Intervention: Biological: AERAS 402
Publications *	Hoft DF, Blazevic A, Stanley J, Landry B, Sizemore D, Kpamegan E, Gearhart J, Scott A, Kik S, Pau MG, Goudsmit J, McClain JB, Sadoff J. A recombinant adenovirus expressing immunodominant TB antigens can significantly enhance BCG-induced human immunity. Vaccine. 2012 Mar 9;30(12):2098-108. doi: 10.1016/j.vaccine.2012.01.048. Epub 2012 Jan 30.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 21, 2011)	12
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2012
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Is male or female; Is age 18 through 45 years on Study Day 0; Has completed written informed consent; Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar; Has general good health, confirmed by medical history and physical examination; Has Body Mass Index (BMI) between 19 and 30 (kg/m2); Has ability to complete follow-up period of 182 days as required by the protocol; Females: Ability to avoid pregnancy from 28-days prior to initial study vaccination through the duration of their participation in the study.; Will commit to avoiding elective surgery for the duration of the study; Has ability to stay in contact with the investigative site for the duration of the study; Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol Exclusion Criteria: Acute illness on the day of randomization; Oral temperature ≥37.5°C 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; Received any investigational drug therapy or vaccine within 182 days; Received any standard vaccine within 42 days; Participated in any clinical trial of an investigational adenovirus-based vaccine previously.; Current chronic drug therapy; 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; History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine; Previous medical history that may compromise the safety of the subject in the study; Evidence of a new acute illness that may compromise the safety of the subject in the study; Evidence of chronic hepatitis (e.g., hepatitis B core antibody, or hepatitis C antibody, or other); 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 three or more days per week; Positive urine test for illicit drugs (opiates, cocaine, amphetamines); History or evidence of any systemic disease on physical examination; 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; are nursing; Abnormal (per local laboratory parameters) hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, absolute lymphocyte count, prothrombin time (PT), partial thromboplastin time (PTT), serum creatinine, GGT, ALT, AST, total bilirubin, alkaline phosphatase (ALP), or creatinine drawn within 36 hours prior to randomization.; Laboratory test evidence of Mtb infection; Tuberculin skin test evidence of Mtb infection, defined as 15 mm of induration or greater.; Anal intercourse with another man at least one time (with or without condoms); Exchange of goods, money, services or drugs for sex.; Use of intravenous drugs.; Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual; Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs; Oral to genital contact within the last 12 months with a known user of intravenous drug; Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner; Oral to genital contact within the last 12 months with an individual known to have more than one sex partner
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	India
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01378312
Other Study ID Numbers ICMJE	C-004-402
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Aeras
Study Sponsor ICMJE	Aeras
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Vanya Dhagat, MD Lotus Labs
PRS Account	Aeras
Verification Date	November 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP