Evaluation of Manufacturing Lot of StaphVAX - Full Text View

Purpose

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.

Condition	Intervention	Phase
Staphylococcal Infections Chronic Kidney Failure	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine	Phase III

MedlinePlus related topics:

Kidney Failure Staphylococcal Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

Type-specific antibody concentrations [ Time Frame: 6 weeks after vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Type-specific antibody concentrations [ Time Frame: 3 weeks after vaccine dose ] [ Designated as safety issue: No ]
Elicited vaccine reactogenicity. [ Time Frame: daily for 7 days after dose ] [ Designated as safety issue: Yes ]

Enrollment:	65
Study Start Date:	March 2005
Study Completion Date:	November 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vaccine: Experimental single dose of StaphVAX in hemodialysis patients	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine single IM dose totalling 200 mcg of conjugate

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211900

Locations


United States, Alabama
	Trialogic Research
	Madison, Alabama, United States, 35758

Sponsors and Collaborators

Nabi Biopharmaceuticals

Investigators


Study Director:	Matt Hohenboken, MD, PhD	Nabi Biopharmaceuticals

More Information

Responsible Party:	Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Director, Clinical & Medical Affairs )
Study ID Numbers:	Nabi-1367
First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00211900
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections

Staphylococcal Infections

Gram-Positive Bacterial Infections

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211900