Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00079820
• Date of registration: 15/03/2004
• Primary sponsor: Sanofi-Aventis
• Public title: Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults
• Scientific title: The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination
• Date of first enrolment: April 2004
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00079820
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects must meet the following to be eligible for the study:

- adult males or females who provided informed consent for the study.

- adults 18 and 31 years (inclusive).

- good general health,

- female subjects must not be pregnant or lactating and be on appropriate contraception
or be a female unable to bear children.

- subjects be available for participation during the entire study.

Exclusion Criteria:

Any of the following exclusion criteria are met, the subject is NOT eligible.

- military service prior to 1989 or after December 13th, 2002.

- history of previous smallpox vaccination

- known/suspected history of immunodeficiency, or with current radiation treatment or
use of immunosuppressive or anti-neoplastic drugs.

- subjects with a household member or intimate contact with the same conditions listed
above.

- known or suspected impairment of other immunologic function.

- malignancy, including squamous cell or basal cell skin cancer at vaccination site

- active autoimmune disease.

- subjects with known eye diseases or other conditions that require the use of
corticosteroid eye drops.

- known/history of cardiac disease.

- subjects who have been diagnosed with 3 or more of the following risk factors for
ischemic coronary disease: a) high blood pressure b) elevated blood cholesterol
levels c) diabetes or high blood sugar d) first degree relative (for example, mother,
father, brother, or sister) who had a heart condition before the age of 50 e) smoke
cigarettes

- subjects with a history of palpitations or abnormalities of cardiac rhythm.

- subjects with odd ECG patterns

- subjects with a ten percent or greater risk of developing a myocardial infarction or
coronary death within the next 10 years.

- positive or elevated creatinine kinase, CK-MB, or Troponin I laboratory test levels.

- abnormalities of clinical laboratory assessments.

- past history or current diagnosis of chronic renal disease, adverse reactions to
drugs characterized by renal impairment, a serum creatinine > 1.5 mg/dL, or presence
of 1+ protein in urinalysis at screening and a calculated creatinine clearance of not
less than 80 mL/min.

- current diagnosis or past history of eczema.

- subjects with a household member or intimate contact with the same conditions listed
above.

- presence of acute, chronic, or exfoliative skin conditions, open wounds, or burns.

- history of keloid formation.

- known allergies to MVA or to any known components (Neomycin, Gentamycin) of the
vaccine.

- known allergy to eggs or egg products.

- known allergies to any component of the Dryvax® vaccine. Antibiotics in Dryvax®
include neomycin, streptomycin, chlortetracycline, and polymixin B.

- known allergies to any known component of the Dryvax® diluent (i.e., glycerin and
phenol).

- known allergies to any known component of VIG, (i.e., thimerosal or previous allergic
reaction to immunoglobulins).

- known allergies to cidofovir or sulphur containing drugs, including probenecid,
trimethoprim, and sulfonamide antibiotics.

- transfusion of blood or treatment with any blood product, including intramuscular or
intravenous serum globulin within 6 months of the screening visit.

- positive serology result for HIV, hepatitis B surface antigen, or hepatitis C.

- current diagnosis or history within six months of the screening visit of drug or
alcohol abuse disorders.

- significant acute or chronic psychiatric illness.

- female subjects with a positive serum pregnancy test result

- subjects with a household member or direct contact with someone who is pregnant or
lactating.

- temperature or acute illness within 3 days prior to vaccination

- inoculation with an inactivated vaccine with 14 days of Day 0 or with a live
attenuated vaccine within 30 days of Day 0.

- subjects who have participated in another investigational drug or vaccine trial
within 30 days of Day 0.

- subjects who are planning on donating blood or organs within 30 days of vaccination.



Age minimum: 18 Years
Age maximum: 31 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Smallpox

Intervention(s)

Biological: ACAM3000 MVA Vaccine

Primary Outcome(s)

Safety [Time Frame: Study Completion]

Secondary Outcome(s)

Immunogenicity [Time Frame: Study Completion]

Secondary ID(s)

H-249-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors