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

Primary Purpose

Staphylococcal Infections, Chronic Kidney Failure

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Staph aureus types 5 and 8 conjugate vaccine

placebo

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring Staphylococcus aureus, Vaccine, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

multiple sites: contact Central Study coordination

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

vaccine, schedule 1

vaccine, schedule 2

placebo, schedule 1

placebo, schedule 2

Arm Description

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

3rd and 4th dose of vaccine on modified schedule

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

3rd and 4th dose of placebo on modified schedule

Outcomes

Primary Outcome Measures

serotype-specific antibody concentrations

Secondary Outcome Measures

serotype-specific antibody concentrations

elicited vaccine reactogenicity

Full Information

NCT ID

NCT00130260

First Posted

August 12, 2005

Last Updated

December 26, 2007

Sponsor

Nabi Biopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00130260

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Why Stopped

unsatisfactory efficacy data from preceding trial

Study Start Date

August 2005 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nabi Biopharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Infections, Chronic Kidney Failure

Keywords

Staphylococcus aureus, Vaccine, Randomized Controlled Trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vaccine, schedule 1

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine, schedule 2

Arm Type

Experimental

Arm Description

3rd and 4th dose of vaccine on modified schedule

Arm Title

placebo, schedule 1

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

placebo, schedule 2

Arm Type

Placebo Comparator

Arm Description

3rd and 4th dose of placebo on modified schedule

Intervention Type

Biological

Intervention Name(s)

Staph aureus types 5 and 8 conjugate vaccine

Other Intervention Name(s)

StaphVAX®

Intervention Description

each IM dose contains 200 mc total conjugate

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

placebo to match StaphVAX

Primary Outcome Measure Information:

Title

serotype-specific antibody concentrations

Time Frame

6 weeks after each dose

Secondary Outcome Measure Information:

Title

serotype-specific antibody concentrations

Time Frame

at several other time points up to 12 months after dose

Title

elicited vaccine reactogenicity

Time Frame

daily for 7 days after each dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matt Hohenboken, MD, PhD

Organizational Affiliation

Nabi Biopharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

multiple sites: contact Central Study coordination

City

Birmingham

State/Province

Alabama

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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