Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease - Full Text View

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00130260

Purpose

This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.

Condition	Intervention	Phase
Staphylococcal Infections Chronic Kidney Failure	Biological: Staph aureus types 5 and 8 conjugate vaccine Biological: placebo	Phase III

MedlinePlus related topics: Kidney Failure Staphylococcal Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

serotype-specific antibody concentrations [ Time Frame: at several other time points up to 12 months after dose ] [ Designated as safety issue: No ]
elicited vaccine reactogenicity [ Time Frame: daily for 7 days after each dose ] [ Designated as safety issue: Yes ]

Enrollment:	99
Study Start Date:	August 2005
Study Completion Date:	April 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vaccine, schedule 1: Experimental 3rd and 4th dose of vaccine, on original schedule	Biological: Staph aureus types 5 and 8 conjugate vaccine each IM dose contains 200 mc total conjugate
vaccine, schedule 2: Experimental 3rd and 4th dose of vaccine on modified schedule	Biological: Staph aureus types 5 and 8 conjugate vaccine each IM dose contains 200 mc total conjugate
placebo, schedule 1: Placebo Comparator 3rd and 4th dose of placebo, on original schedule	Biological: placebo placebo to match StaphVAX
placebo, schedule 2: Placebo Comparator 3rd and 4th dose of placebo on modified schedule	Biological: placebo placebo to match StaphVAX

Eligibility

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

Criteria

Inclusion Criteria:

Participation in prior study Nabi-1371
Written informed consent
Negative serum pregnancy test, where 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 2 months prior to injection
Hypersensitivity to components of StaphVAX

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130260

Locations

United States, Alabama
multiple sites: contact Central Study coordination
Birmingham, Alabama, United States

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-1372
Study First Received:	August 12, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00130260
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:

Staphylococcus aureus
Vaccine
Randomized Controlled Trial

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 January 16, 2009