Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Completed · Phase 2

Conditions studied: Smallpox

In brief

The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

Key facts

Study ID

NCT00053482

Run by

Emergent BioSolutions

People needed

357

Starts

2003-01-01

Expected to finish

2003-10-01

Last updated by the study team

2024-03-18

Who can join

Age: 28 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.
• females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
• agree to be available for the entire study and agree to comply with all requirements.

You may not qualify if…

• children 1 year of age or younger in the household or be in close contact
• smallpox vaccination within ten years
• known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
• renal disease
• current or past history of eczema or a household member or direct contact who has eczema.
• known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
• known allergy or past allergic reaction to blood products.
• known allergy to cidofovir or sulfa-containing drugs.
• history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
• transfusion of blood or treatment with any blood product.
• current or history of drug or alcohol abuse
• innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Where it is running

• PRA International — Lenexa, Kansas, United States
• Bio-Kinetic Clinical Applications — Springfield, Missouri, United States
• Memorial Hospital of Rhode Island Division of Infectious Diseases — Pawtucket, Rhode Island, United States

Full record on ClinicalTrials.gov

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