A Study to Evaluate Safety and Immunogenicity of AERAS-402

NCT01378312 | Completed Phase 1 DMC

• 1 other identifier: C-004-402
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

vaccine; TB; tuberculosis

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Adverse Events by treatment group

  The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).

  Day 56

Secondary Outcomes (1)

• Immune Response

  Day 182

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Biological: Placebo

AERAS 402 Arm

ACTIVE COMPARATOR

Biological: AERAS 402

Interventions

AERAS 402 BIOLOGICAL

0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28

AERAS 402 Arm

Placebo BIOLOGICAL

0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28

Placebo Arm

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aeras: lead

Study Sites (1)

Lotus Labs

Bangalore, Bangalore, India

Location

Related Publications (1)

• 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.

  PMID: 22296955 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Vanya Dhagat, MD

  Lotus Labs

  PRINCIPAL INVESTIGATOR

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, 2011
• First Posted: June 22, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 17, 2014

Record last verified: 2012-11

Locations

IN (1)