Pneumococcal Infection Clinical Trial
Official title:
Evaluation of a 9-valent CRM 197- Conjugated Pneumococcal Polysaccharide Vaccine in Elderly Adults
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.
Status | Completed |
Enrollment | 180 |
Est. completion date | December 2002 |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Persons age 65 years and older. - Able to give informed consent. Informed consent will be assessed with a brief questionnaire. - Subjects must be physically able to monitor and record side effects, including reading a digital thermometer and measuring erythema and induration, with assistance from others as needed. - Subjects must be available for follow-up over the next 9 months Exclusion Criteria: - Known previous receipt of licensed pneumococcal PS vaccination within the previous 5 years. Prior vaccination history will be obtained from current and previous health care providers, if available. - Previous vaccination with any pneumococcal glycoconjugate vaccine. - High risk medical condition for pneumococcus such as splenectomy, nephrotic syndrome, or lymphoma. - Immunosuppressive diseases or immunosuppressive therapy. This includes doses of steroids greater than 10 mg daily (or its equivalent), cancer chemotherapy, or known HIV disease. - History of idiopathic thrombocytopenic purpura. - Acute respiratory illness or fever (temperature >38 degrees C or 100.4 degrees F) within one week of vaccination. Subjects can be reconsidered for enrollment when they recover from their illness. - History of allergy to any of the vaccine components or previous severe allergic reaction to any vaccination. - Any medical condition that would in the opinion of the investigator, interfere with the evaluation of the study objectives. - Documented S. pneumoniae infection in the past 5 years. - Screening laboratory values outside the following limits: 1) hematocrit below 28%, 2) WBC <3,000 or over 13,500 per ul, 3) platelets below 125,000 or above 500,000 per ul, 4) creatinine above 2.8 mg/dl or BUN above 75 mg/dl, and 5) AST/SGOT or ALT/SGPT over 110 U/L, Alkaline phosphatase over 200 IU/I or a bilirubin over 2.8 mg/dl. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse effects. | Duration of study. | Yes | |
Primary | Antibody response to carrier protein, effects on functional antibody status and on nasal carriage of S. pneumoniae. | Before and 1 month following each vaccine or placebo. | No | |
Primary | Standard ELISA measurements of serotype specific antibody. | Before and 1 month following each vaccine or placebo. | No |
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