230
Participants
Start Date
March 27, 2013
Primary Completion Date
December 22, 2015
Study Completion Date
December 19, 2016
Pfs25-EPA/Alhydrogel
The Pfs25-EPA conjugate was produced by reaction between thiolated PpPfs25 and maleimideactivated EcEPA, followed by purification using size-exclusion chromatography. The cGMP Pfs25-EPA conjugate Lot# WRAIR1634 was manufactured at Walter Reed Bioproduction facility in cGMP compliance in May 2010. Alhydrogel (Brenntag, Denmark) is an aluminum hydroxide gel and has been extensively used as an adjuvant in licensed human vaccines. Alhydrogel is supplied as a sterile product in water without preservatives. Pfs25- EPA/Alhydrogel WRAIR Lot #1668 was manufactured and filled as single-use vials at Walter Reed Bioproduction facility in cGMP compliance in October 2010. Each vial contains 78 g/mL conjugated Pfs25, 93 g/mL conjugated EPA and 1600 g/mL Alhydrogel in a volume of 0.8 mL. The vial label reads: 78 g/mL Conjugated Pfs25 on Alhydrogel .
Euvax B
Euvax B consists of highly purified, noninfectious particles of HBsAg absorbed onto aluminum salts as an adjuvant and preserved with thimerosal.
Menactra
Menactra , Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar (3) and grown in Watson Scherp (4) media. The polysaccharides are extracted from the N meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration.
Malaria Research and Training Center, Bamako
Malaria Research and Training Center, Bamako, Mali
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH