Study of AERAS 422 in Healthy Adults

NCT01340820 | Completed Phase 1 DMC

• 1 other identifier: C-007-422
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Safety

  Assessment of collected unsolicited and solicited adverse events (including site of injection reaction (pain, erythema, induration, ulceration, drainage, and scarring), regional lymphadenopathy (axillary and cervical), fever, headache, myalgia, arthralgia and fatigue. The adverse event collection timeframe includes all events that occur up to 56 days after study vaccination. Assessment of serious adverse events will be based on events collected throughout the duration of the study. All safety data will be evaluated before moving into the next successive dose level.

  Days 0, 3, 7, 14, 28, 56, 84, 112, 140 & 182

Secondary Outcomes (1)

• Immunogenicity

  Days 0, 14, 28, 56, 84, 112, 140 and 182

Study Arms (3)

AERAS-422 Low dose

EXPERIMENTAL

\>=10\^5 to \< 10\^6 CFU

Drug: AERAS-422

AERAS-422 High Dose

EXPERIMENTAL

\>=10\^6 CFU

Drug: AERAS-422

BCG Tice

ACTIVE COMPARATOR

BCG Tice 1-8 x 10\^5 CFU

Drug: BCG Tice

Interventions

AERAS-422 DRUG

rBCG

Also known as: BCG Tice

AERAS-422 High Dose; AERAS-422 Low dose

BCG Tice DRUG

1-8 x 10\^5 CFU

BCG Tice

Eligibility Criteria

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

You may qualify if:

• ≥18 years and ≤45 years of age on randomization day
• Has general good health, confirmed by medical history and physical examination
• Has a screening body mass index (BMI) ≥19 and \<33
• 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 use acceptable method of avoiding pregnancy from 28 days prior to randomization through the end of the study.
• Acceptable methods of avoiding pregnancy -Females physically capable of pregnancy must have:
• Negative urine pregnancy test within 21 days prior to randomization AND within 24 hours prior to Study Day 0 vaccination
• Ability to complete all protocol study visits and be reachable by telephone
• Provided written informed consent prior to screening evaluations
• Completed simultaneous enrollment in the Aeras Vaccine Registry protocol

You may not qualify if:

• Acute illness on randomization day
• Oral temperature \>=37.5 degrees C on randomization day
• Abnormal laboratory values from blood collected within 21 days prior to randomization as follows:
• Positive test for hepatitis B core antibody or hepatitis C antibody
• Positive test for HIV
• Positive urine test for opiates, cocaine, or amphetamines
• Positive QuantiFERON®-TB Gold test
• History of treatment for active or latent tuberculosis infection
• Other evidence of active or latent tuberculosis, in the opinion of the investigator
• Tuberculin skin test (TST) within 90 days prior to randomization
• History or evidence of allergic disease or reaction that in the opinion of the investigator is likely to be exacerbated by any component of AERAS-422 or BCG Tice
• History or evidence of autoimmune disease, immunosuppression, or immunodeficiency, in the opinion of the investigator
• History or evidence of cheloid formation, axillary or cervical lymphadenopathy, or other dermatologic or anatomic findings that, in the opinion of the investigator, may interfere with the assessment of injection site reactions
• History or evidence of any other acute or chronic disease or condition that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the evaluation of the vaccine safety or immunogenicity
• Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely the subject will comply with the protocol

Sponsors & Collaborators

• Aeras: lead

Study Sites (1)

St. Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Related Publications (1)

• Hoft DF, Blazevic A, Selimovic A, Turan A, Tennant J, Abate G, Fulkerson J, Zak DE, Walker R, McClain B, Sadoff J, Scott J, Shepherd B, Ishmukhamedov J, Hokey DA, Dheenadhayalan V, Shankar S, Amon L, Navarro G, Podyminogin R, Aderem A, Barker L, Brennan M, Wallis RS, Gershon AA, Gershon MD, Steinberg S. Safety and Immunogenicity of the Recombinant BCG Vaccine AERAS-422 in Healthy BCG-naive Adults: A Randomized, Active-controlled, First-in-human Phase 1 Trial. EBioMedicine. 2016 May;7:278-86. doi: 10.1016/j.ebiom.2016.04.010. Epub 2016 Apr 19.

  PMID: 27322481 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Daniel Hoft, MD

  St. Louis University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: April 25, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

US (1)