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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02430506
• Date of registration: 27/04/2015
• Prospective Registration: No
• Primary sponsor: Aeras
• Public title: A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB C-012-402
• Scientific title: A Phase I Randomized Placebo-controlled Double-blind Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QuantiFERON®-TB Gold (+) and QuantiFERON®-TB Gold (-) Adults Without Evidence of Tuberculosis.
• Date of first enrolment: September 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02430506
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Kenya

Contacts

• Name: Doug Walsh, MD
• Affiliation: U. S. Army Medical Research Unit- Kenya

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is male or female

2. Is age 18 through 45 years on Study Day 0

3. Has completed the written informed consent process

4. Had BCG vaccination at least 5 years ago, documented through medical history or
presence of scar

5. Females: Ability to avoid pregnancy from 28 days prior to administration of the study
vaccine through the end of the study.

6. Has general good health, confirmed by medical history and physical examination.

7. Has Body Mass Index (BMI) between 18 and 30 (wt./ht.2) by nomogram

8. Has ability to complete follow-up period of 182 days as required by the protocol

9. Is able and willing to commit to avoiding elective surgery for the duration of the
study.

10. Is able and willing to stay in contact with the study site for the duration of the
study.

11. Has completed simultaneous enrollment in Aeras Vaccine Development Registry Protocol.

Exclusion Criteria:

1. Acute illness on the day of randomization.

2. Fever =37.5°C on the day of randomization.

3. Evidence of any significant active infection on the day of randomization.

4. Used immunosuppressive medication within 45 days before entry into the study (inhaled
and topical corticosteroids are permitted).

5. Received immunoglobulin or blood products within 45 days before entry into the study.

6. Received any investigational drug therapy or vaccine within 182 days before the first
dose of study vaccine in this protocol.

7. 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).

8. Received any adenovector based vaccine previously.

9. Current chronic drug therapy including hormones such as thyroxin, insulin, etc.
(Estrogen and progesterone replacement and contraceptives are permitted)

10. 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.

11. History of allergic disease or reactions likely to be exacerbated by any component of
the study vaccine.

12. Previous medical history that may compromise the safety of the subject in the study.

13. Evidence of a new acute illness that may compromise the safety of the subject in the
study.

14. Pregnant or lactating/nursing females.

15. Evidence of chronic hepatitis including a positive test for hepatitis B core
antibody, or hepatitis C antibody.

16. Inability to discontinue daily medications except contraceptives during the study.

17. History of alcohol or drug abuse within the past 2 years.

18. Tobacco or cannabis smoking three or more days per week

19. Positive urine test for illicit drugs (opiates, cocaine, amphetamines).

20. History or evidence of any systemic disease on physical examination or any acute or
chronic illness that may interfere with the evaluation of the safety or
immunogenicity of the vaccine, including axillary lymphadenopathy

21. History or evidence (including chest X-ray) of active or past tuberculosis

22. Abnormal hemoglobin, hematocrit, white blood cell count, absolute neutrophil count,
absolute lymphocyte count, PT, PTT, GGT, ALT, AST, total bilirubin, ALP, and
creatinine drawn within 36 hours of randomization. CPK must be drawn but the CPK
value is not an exclusion criteria.

23. History of high risk sexual behaviors.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: Placebo

Biological: AERAS-402

Primary Outcome(s)

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. [Time Frame: Day 0 thru Day 182]

Secondary Outcome(s)

Immunogenicity profile of AERAS-402 in healthy, HIV-negative, BCG-vaccinated, QFT-G(+) and QFT-G(-) adults without evidence of tuberculosis disease in Kenya. [Time Frame: Day 0 thru day 182]

Secondary ID(s)

C-012-402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors