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Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Sponsored by Emergent BioSolutions

About this trial

Last updated 7 years ago

Study ID

H-400-003

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
28+ Years
All
All

Trial Timing

Ended 22 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

Exclusion Criteria

- 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.

Locations

Location

Status