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

Chronic Kidney Failure Clinical Trial

— SHIELD-2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00130260
• Other study ID #: Nabi-1372
• Status: Terminated
• Phase: Phase 3
• First received: August 12, 2005
• Last updated: December 26, 2007
• Start date: August 2005
• Est. completion date: April 2006

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: April 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• Staph aureus types 5 and 8 conjugate vaccine
each IM dose contains 200 mc total conjugate
• placebo
placebo to match StaphVAX

Locations

Country	Name	City	State
United States	multiple sites: contact Central Study coordination	Birmingham	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	serotype-specific antibody concentrations		6 weeks after each dose	No
Secondary	serotype-specific antibody concentrations		at several other time points up to 12 months after dose	No
Secondary	elicited vaccine reactogenicity		daily for 7 days after each dose	Yes