Evaluation of Manufacturing Lot of StaphVAX

Chronic Kidney Failure Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211900
• Other study ID #: Nabi-1367
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 26, 2007
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: December 2007
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Staphylococcal Infections

Intervention

Biological:
• S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
single IM dose totalling 200 mcg of conjugate

Locations

Country	Name	City	State
United States	Trialogic Research	Madison	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type-specific antibody concentrations		6 weeks after vaccine dose	No
Secondary	Type-specific antibody concentrations		3 weeks after vaccine dose	No
Secondary	Elicited vaccine reactogenicity.		daily for 7 days after dose	Yes