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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Staphylococcal Infections, Chronic Kidney Failure

Intervention / Treatment
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* Biological: Staph aureus types 5 and 8 conjugate vaccine
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine, schedule 1<br>3rd and 4th dose of vaccine, on original schedule | Biological: Staph aureus types 5 and 8 conjugate vaccine<br>* each IM dose contains 200 mc total conjugate<br>* Other names: StaphVAX®;|
| Experimental: vaccine, schedule 2<br>3rd and 4th dose of vaccine on modified schedule | Biological: Staph aureus types 5 and 8 conjugate vaccine<br>* each IM dose contains 200 mc total conjugate<br>* Other names: StaphVAX®;|
| Placebo Comparator: placebo, schedule 1<br>3rd and 4th dose of placebo, on original schedule | Biological: placebo<br>* placebo to match StaphVAX<br>|
| Placebo Comparator: placebo, schedule 2<br>3rd and 4th dose of placebo on modified schedule | Biological: placebo<br>* placebo to match StaphVAX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotype-specific antibody concentrations |  | 6 weeks after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staphylococcus aureus, Vaccine, Randomized Controlled Trial