Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Serum 89SF is a pooled sera from individuals vaccinated with a 23 valent pneumococcal polysaccharide vaccine collected in the late 1980s. The 89SF standard for ELISA is running low (2-3 year supply) and is insufficient to serve for opsinophagocytosis assay (OPA), which requires large volumes. The objective of this study is to immunize healthy volunteers with licensed polyvalent pneumococcal polysaccharide vaccine (Pneumovax 23) with subsequent blood donation in a quantity sufficient to make reference sera. Two hundred fifty volunteer subjects will be recruited from a total population of up to 600. Study participants will include healthy men and nonpregnant females, ages 18-45. Subjects will undergo physical examination by a licensed clinician, subject interview, and clinical laboratory and serologic testing. Potential subjects must provide written informed consent and meet all eligibility criteria. On Day 0, subjects will receive 0.5 mL pneumococcal vaccine (Pneumovax 23) in the deltoid muscle. Volunteers will remain in the clinic for 30 minutes following immunization for observation of any adverse reactions. Volunteers will return to clinic in 10-35 days following immunization to donate 1 unit (approximately 500 mL) of blood. Volunteers will return for a second donation of 1 unit of blood not less than 8 weeks and not more than 14 weeks following the first donation. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00479323
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date June 2007
Completion date August 2008

See also
  Status Clinical Trial Phase
Completed NCT02201030 - Immunogenicity and Safety Study of NBP606 in Healthy Infants Phase 3
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Completed NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) Phase 3
Recruiting NCT05920499 - The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage N/A
Completed NCT01215175 - Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) Phase 1
Completed NCT02892812 - A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults Phase 1
Completed NCT02116998 - Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae Phase 2
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01193582 - A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria Phase 4
Completed NCT00744263 - Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults Phase 4
Completed NCT00492557 - Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults Phase 3
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Completed NCT00205803 - Study Evaluating Pneumococcal Vaccine in Healthy Infants Phase 1/Phase 2
Completed NCT00137605 - Early Versus Delayed Pneumococcal Vaccination in HIV Phase 1/Phase 2
Completed NCT02531373 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) Phase 1/Phase 2
Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) Phase 2
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2