Pneumococcal Reference Standard

NCT00479323 | Completed Phase 1

• 1 other identifier: 06-0093
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the reference serum supply. Study participants will include 250 healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews, blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the deltoid muscle of the arm. Participants will be involved in the study for approximately 17 weeks.

Conditions

Pneumococcal Infections

Keywords

pneumococcal vaccine, Pneumovax, reference sera, serum 89SF

Outcome Measures

Primary Outcomes (1)

• To immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera.

  Duration of study.

Study Arms (1)

1

OTHER

Immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera.

Biological: Pneumovax 23

Interventions

Pneumovax 23 BIOLOGICAL

Licensed pneumococcal vaccine (Pneumovax 23).

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or nonpregnant female between the ages of 18 to 45 and weighing a minimum of 110 pounds.
• Women of childbearing potential (not surgically sterile or postmenopausal for \>/= 1 year) must agree to practice adequate contraception (ie, barrier method, abstinence, intrauterine device, or licensed hormonal method) for the entire period while on protocol.
• Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination and prior to each blood collection.
• Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
• Subject laboratory tests, including hemoglobin, hematocrit, total white blood count and platelets, aspartate aminotransferase, alanine aminotransferase, and serum protein. All values must be within normal limits (WNL) except AST and ALT that must less than or equal to 1.5 X ULN and total serum protein \>=6.0 gms; Males: hemoglobin \>=13.5 gm/dL, hematocrit \>=41% Females: hemoglobin \>=12.5 gm/dL, hematocrit \>=38%
• Serology for hepatitis B (core antibody), C, HIV, rapid plasma reagin, immunoglobulin and HIV must be negative.
• Subjects must have adequate venous access.
• Participants must communicate an understanding of the protocol and provide written informed consent for the protocol.

You may not qualify if:

• Has received any investigational drug or vaccine within the past 6 months or is currently in any phase of another clinical trial or intends to participate in another clinical trial in the next 6 months.
• Has received any licensed inactivated vaccine within 2 weeks or licensed live vaccine within 4 weeks of screening.
• Has a known allergy to any component of the Pneumovax 23 vaccine.
• Has a history of receiving human blood or any derivative of human blood within the preceding 12 months.
• Has no evidence of skin infection at the potential phlebotomy sites or evidence of systemic or generalized disease that could create a risk of contamination of the serum.
• Has no history of viral hepatitis after the 11th birthday and no history of close contact with an individual diagnosed with viral hepatitis within the past year.
• Is immunosuppressed as a result of underlying illness or treatment or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Long-term use of oral or parenteral steroids or high-dose inhaled steroids within the past 6 months.
• Has a diagnosis of schizophrenia, bipolar disease, major psychiatric diagnosis, or has ever been hospitalized for a psychiatric illness.
• Has a history of alcohol or drug abuse in the past 5 years.
• Has any acute or chronic condition that, in the opinion of the investigator, would render vaccination or blood donation unsafe or the participant unable to meet the requirements of the protocol.

Sponsors & Collaborators

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

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 26, 2016

Record last verified: 2011-04

Locations

US (1)