Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease (SHIELD-2)

Nabi Biopharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Failure; Staphylococcal Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130260

Nabi-1372

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 4 patient groups, including a placebo group

vaccine, schedule 1

Experimental group

Description:

3rd and 4th dose of vaccine, on original schedule

Treatment:

Biological: Staph aureus types 5 and 8 conjugate vaccine

vaccine, schedule 2

Experimental group

Description:

3rd and 4th dose of vaccine on modified schedule

Treatment:

Biological: Staph aureus types 5 and 8 conjugate vaccine

placebo, schedule 1

Placebo Comparator group

Description:

3rd and 4th dose of placebo, on original schedule

Treatment:

Biological: placebo

placebo, schedule 2

Placebo Comparator group

Description:

3rd and 4th dose of placebo on modified schedule

Treatment:

Biological: placebo