Testing Pfs25-EPA/Alhydrogel as a Potential Malaria Transmission Blocking Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

March 27, 2013

Primary Completion Date

December 22, 2015

Study Completion Date

December 19, 2016

Conditions
Malaria
Interventions
BIOLOGICAL

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 .

BIOLOGICAL

Euvax B

Euvax B consists of highly purified, noninfectious particles of HBsAg absorbed onto aluminum salts as an adjuvant and preserved with thimerosal.

BIOLOGICAL

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.

Trial Locations (1)

Unknown

Malaria Research and Training Center, Bamako

All Listed Sponsors
collaborator

Malaria Research and Training Center, Bamako, Mali

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01867463 - Testing Pfs25-EPA/Alhydrogel as a Potential Malaria Transmission Blocking Vaccine | Biotech Hunter | Biotech Hunter