Phase 2
N=353
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT00053495 ↗Enrolled (actual)
353
Serious AEs
0.9%
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 2; 4; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vaccinia virus: ACAM2000 smallpox vaccine (Biological); vaccinia virus (calf lymph): Dryvax (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emergent BioSolutions
- Primary completion
- Jun 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
2; 4; 3; 4; 2; 0 | — |
| PRIMARY Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
212; 278; 425; 582; 1515 | — |
| PRIMARY Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
28; 73; 84; 48; 47 | — |
Summary
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Eligibility Criteria
Inclusion criteria
- 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
- military service prior to 1989.
- history of previous smallpox vaccination.
- children 1 year of age or younger in the household or be in close contact
- smallpox vaccination within ten years
- known or suspected human immunodeficiency 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
- inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Data sourced from ClinicalTrials.gov (NCT00053495). 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.