Phase 2
N=357
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT00053482 ↗Enrolled (actual)
357
Serious AEs
0.6%
Results posted
Feb 2011
Primary outcome: Primary: The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 77; 112; 76; 91 PRNT50 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACAM2000 Smallpox Vaccine (Biological); Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® (Biological)
- Age
- Adult, Older Adult · 28+ yrs
- Sex
- All
- Sponsor
- Emergent BioSolutions
- Primary completion
- Apr 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
77; 112; 76; 91; 186; 244 | — |
| PRIMARY Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
13; 31; 41; 38; 39 | — |
| PRIMARY Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
1; 1; 1; 1; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT00053482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.