Evaluation of Manufacturing Lot of StaphVAX

Nabi Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Failure; Staphylococcal Infections

Treatments: Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00211900

Nabi-1367

Details and patient eligibility

About

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 8 wk of hemodialysis for ESRD,
• have written informed consent,
• a negative serum pregnancy test if appropriate,
• and 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

vaccine

Experimental group

Description:

single dose of StaphVAX in hemodialysis patients

Treatment:

Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine