9-valent CRM 197 Pneumococcal

NCT00133549 | Completed Phase 2

• 1 other identifier: 99-023
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pneumococcal Infection

Keywords

pneumococcal vaccine, 23-valent polysaccharide vaccine, elderly

Outcome Measures

Primary Outcomes (3)

• Adverse effects.

  Duration of study.

• 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.

• Standard ELISA measurements of serotype specific antibody.

  Before and 1 month following each vaccine or placebo.

Study Arms (3)

2

EXPERIMENTAL

Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): CRM-PS; Vaccine dose 3 (month 8): PS.

Biological: PNU-IMUNE®23; Biological: Nine-valent pneumococcal conjugate (PNCRM9)

1

EXPERIMENTAL

Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): PS.

Drug: Placebo; Biological: PNU-IMUNE®23; Biological: Nine-valent pneumococcal conjugate (PNCRM9)

3

ACTIVE COMPARATOR

Vaccine dose 1: PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): saline placebo.

Drug: Placebo; Biological: PNU-IMUNE®23

Interventions

Placebo DRUG

Saline placebo administered in a volume of 0.5 ml intramuscularly.

1; 3

PNU-IMUNE®23 BIOLOGICAL

The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly.

1; 2; 3

Nine-valent pneumococcal conjugate (PNCRM9) BIOLOGICAL

Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly.

1; 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of Rochester

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: November 1, 2000
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: October 17, 2014

Record last verified: 2011-05

Locations

US (2)