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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130260

Acronym

SHIELD-2

Enrollment

Registered

2005-08-15

Start date

2005-08-31

Completion date

2006-04-30

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Staphylococcal Infections

Keywords

Staphylococcus aureus, Vaccine, Randomized Controlled Trial

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.

Interventions

BIOLOGICALStaph aureus types 5 and 8 conjugate vaccine

each IM dose contains 200 mc total conjugate

BIOLOGICALplacebo

placebo to match StaphVAX

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
serotype-specific antibody concentrations	6 weeks after each dose

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026