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

Phase 3

Terminated

• Conditions: Staphylococcal Infections; Chronic Kidney Failure
• Interventions: Biological: Staph aureus types 5 and 8 conjugate vaccine; Biological: placebo

• Registration Number: NCT00130260
• Lead Sponsor: Nabi Biopharmaceuticals

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

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Primary Completion: 2005-12
• Study Completion: 2006-04
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaccine, schedule 2	Staph aureus types 5 and 8 conjugate vaccine	3rd and 4th dose of vaccine on modified schedule
placebo, schedule 1	placebo	3rd and 4th dose of placebo, on original schedule
placebo, schedule 2	placebo	3rd and 4th dose of placebo on modified schedule
vaccine, schedule 1	Staph aureus types 5 and 8 conjugate vaccine	3rd and 4th dose of vaccine, on original schedule

Primary Outcome Measures

Name	Time	Method
serotype-specific antibody concentrations	6 weeks after each dose

Secondary Outcome Measures

Name	Time	Method
serotype-specific antibody concentrations	at several other time points up to 12 months after dose
elicited vaccine reactogenicity	daily for 7 days after each dose

Trial Locations

Locations (1)

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