A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB

NCT02430506 | Completed Phase 1 DMC

• 1 other identifier: C-012-402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 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 in Kenya who have already been vaccinated with BCG.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Safety of AERAS-402 in healthy, HIV-negative, BCG-vaccinated, QuantiFERON®-TB Gold In-Tube test (QFT-G)(+) and QFT-G(-) adults without evidence of tuberculosis disease in Kenya.

  Collection of solicited and unsolicited adverse events.

  Day 0 thru Day 182

Secondary Outcomes (1)

• Immunogenicity profile of AERAS-402 in healthy, HIV-negative, BCG-vaccinated, QFT-G(+) and QFT-G(-) adults without evidence of tuberculosis disease in Kenya.

  Day 0 thru day 182

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1.0 mL sterile buffer administered by intramuscular (IM) injection to deltoid area on days 0 and 56.

Biological: Placebo

AERAS-402

EXPERIMENTAL

1.0 mL containing 3 x 10\^10 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non-animal source) and water. Administered intramuscular (IM) injection to deltoid area on days 0 and 56.

Biological: AERAS-402

Interventions

Placebo BIOLOGICAL

This is the identical buffer solution in which AERAS-402 is formulated.

Placebo

AERAS-402 BIOLOGICAL

Given to 8 participants that were QFT-G(-) at screening and 8 participants that were GFT-G(+) at screening.

AERAS-402

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 the written informed consent process
• Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
• Females: Ability to avoid pregnancy from 28 days prior to administration of the study vaccine through the end of the study.
• Has general good health, confirmed by medical history and physical examination.
• Has Body Mass Index (BMI) between 18 and 30 (wt./ht.2) by nomogram
• Has ability to complete follow-up period of 182 days as required by the protocol
• Is able and willing to commit to avoiding elective surgery for the duration of the study.
• Is able and willing to stay in contact with the study 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.
• Fever ≥37.5°C on the day of randomization.
• Evidence of any significant active infection on the day of randomization.
• Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted).
• Received immunoglobulin or blood products within 45 days before entry into the study.
• Received any investigational drug therapy or vaccine within 182 days before the first dose of study vaccine in this protocol.
• Received any standard vaccine within 45 days before the first dose of study vaccine in this protocol, through the last study visit (the use of licensed drugs or vaccines medically indicated during the study is permitted).
• Received any adenovector based vaccine previously.
• Current chronic drug therapy including hormones such as thyroxin, insulin, etc. (Estrogen and progesterone replacement and contraceptives are permitted)
• 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-1 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.
• Pregnant or lactating/nursing females.
• Evidence of chronic hepatitis including a positive test for hepatitis B core antibody, or hepatitis C antibody.

Sponsors & Collaborators

• Aeras: lead

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (1)

• Walsh DS, Owira V, Polhemus M, Otieno L, Andagalu B, Ogutu B, Waitumbi J, Hawkridge A, Shepherd B, Pau MG, Sadoff J, Douoguih M, McClain JB; Aeras C-012-402 Study Team. Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON((R))-TB Gold (+) Kenyan adults without evidence of tuberculosis. Vaccine. 2016 May 5;34(21):2430-2436. doi: 10.1016/j.vaccine.2016.03.069. Epub 2016 Mar 26.

  PMID: 27026148 BACKGROUND

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

• Doug Walsh, MD

  U. S. Army Medical Research Unit- Kenya

  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: April 27, 2015
• First Posted: April 30, 2015
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

KE (1)