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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 12, 2005

Last Updated Date

December 26, 2007

Start Date ^†

August 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00130260 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

serotype-specific antibody concentrations at several other time points after dose
safety

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Staphylococcal Infections
Chronic Kidney Failure

Intervention ^†

Biological: Staph aureus types 5 and 8 conjugate vaccine
Biological: placebo

Study Arms / Comparison Groups

Experimental: 3rd and 4th dose of vaccine, on original schedule
Experimental: 3rd and 4th dose of vaccine on modified schedule
Placebo Comparator: 3rd and 4th dose of placebo, on original schedule
Placebo Comparator: 3rd and 4th dose of placebo on modified schedule

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

April 2006

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00130260

Responsible Party

Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Nabi Biopharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Matt Hohenboken, MD, PhD

Nabi Biopharmaceuticals

Information Provided By

Nabi Biopharmaceuticals

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.