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

Phase 3TerminatedNCT00130260

Nabi Biopharmaceuticals99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Staphylococcal Infections Chronic Kidney Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

serotype-specific antibody concentrations

Time frame: 6 weeks after each dose

Secondary Outcomes

serotype-specific antibody concentrations

Time frame: at several other time points up to 12 months after dose

elicited vaccine reactogenicity

Time frame: daily for 7 days after each dose