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OpenTrials
Completed

NCT Number: NCT00211900

Evaluation of Manufacturing Lot of StaphVAX

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trialogic Research

Madison, Alabama, 35758, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 8 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

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

Treatment and study plan

S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

Biological

single IM dose totalling 200 mcg of conjugate

Other names: StaphVAX®

Primary outcomes

  1. Type-specific antibody concentrations

    Time frame: 6 weeks after vaccine dose

Secondary outcomes

  1. Type-specific antibody concentrations

    Time frame: 3 weeks after vaccine dose

  2. Elicited vaccine reactogenicity.

    Time frame: daily for 7 days after dose

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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