Staphylococcal Infections
Conditions
Brief summary
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.
Interventions
Sponsors
Vanderbilt University
Nabi Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy, * written informed consent, * negative serum pregnancy test if appropriate, * expect to comply with protocol procedures and schedule
Exclusion criteria
* known HIV, * immunomodulatory drugs, * malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer), * active infection in the 2 weeks prior to study injection, * serious S. aureus infection within the last 3 months prior to injection, * use of investigational drugs, vaccines or devices within the prior 30 days, * hypersensitivity to components of StaphVAX
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type-specific antibody concentrations 6 weeks after vaccine dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody concentrations at other time points. | — |
| Elicited health events. | — |
Countries
United States
Outcome results
None listed