Phase I clinical trial with a hexavalent PorA containing meningococcal outer membrane vesicle vaccine.
A meningococcal outer membrane vesicle (OMV) vaccine was prepared from two production strains designed to express three serosubtype-specific class 1 outer membrane proteins or PorA. The resulting hexavalent PorA OMV vaccine contained the serosubtypes P1.7,16; P1.5,2; P1.19,15; P1.7h,4; P1.5c,10; P1.12,13 and were used to immunize adult volunteers. A single immunization with two dosages, 7.5 and 15 micrograms of the individual PorAs, was studied. The vaccine was considered safe for further use. Approximately half of the volunteers demonstrated a fourfold increase in bactericidal antibody activity against six test strains expressing the specific PorAs when given the higher dosage. This bactericidal activity was found to be directed against PorA.
Peeters
C C
CC
Laboratory of Vaccine Development and Immune Mechanisms, RIVM, Bilthoven, The Netherlands.
Rümke
H C
HC
Sundermann
L C
LC
Rouppe van der Voort
E M
EM
Meulenbelt
J
J
Schuller
M
M
Kuipers
A J
AJ
van der Ley
P
P
Poolman
J T
JT
D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D001770:Blood Bactericidal Activity; D015153:Blotting, Western; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008589:Meningococcal Infections / Q000517:prevention & control*; D018272:Porins / Q000276:immunology*
D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D018272:Porins; C057699:porin protein, Neisseria