Evaluation of Manufacturing Lot of StaphVAX

NCT00211900 | Completed Phase 3

• 1 other identifier: Nabi-1367
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Conditions

Staphylococcal Infections; Chronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

• Type-specific antibody concentrations

  6 weeks after vaccine dose

Secondary Outcomes (2)

• Type-specific antibody concentrations

  3 weeks after vaccine dose

• Elicited vaccine reactogenicity.

  daily for 7 days after dose

Study Arms (1)

vaccine

EXPERIMENTAL

single dose of StaphVAX in hemodialysis patients

Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine BIOLOGICAL

single IM dose totalling 200 mcg of conjugate

Also known as: StaphVAX®

vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• wk of hemodialysis for ESRD,
• have written informed consent,
• a negative serum pregnancy test if appropriate,
• and expect to comply with protocol procedures and schedule

You may not qualify if:

• 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 3 months prior to injection,
• use of investigational drugs, vaccines or devices within the prior 30 days,
• hypersensitivity to components of StaphVAX

Sponsors & Collaborators

• Nabi Biopharmaceuticals: lead

Study Sites (1)

Trialogic Research

Madison, Alabama, 35758, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Kidney Failure, Chronic

Interventions

StaphVax

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matt Hohenboken, MD, PhD

  Nabi Biopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 4, 2008

Record last verified: 2007-12

Locations

US (1)