Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults.
Healthy adults, 18-55 years old, were immunized once with a tetravalent (serogroups A, C, Y, and W-135) meningococcal vaccine conjugated to diphtheria toxoid at 1 of 3 doses and were monitored for safety, reactogenicity, and immunogenicity. No immediate reactions were observed. Only 1 of 89 subjects reported fever; only 1 reported any severe reactogenicity (local pain/soreness, chills, arthralgia, anorexia, and malaise). For each serogroup and in each dose group, the geometric mean serum bactericidal antibody (SBA) titer and immunoglobulin G concentration increased after immunization. In the 4- and 10-microg-dose groups, all subjects had SBA titers >/=8 against serogroups A and C, and 89% and 93% of subjects had SBA titers >/=8 against serogroups Y and W-135, respectively. The A, C, Y, and W-135 Neisseria meningitidis-diphtheria toxoid conjugate vaccine, when given to healthy adults as a single intramuscular injection of 1, 4, or 10 microg/serogroup, is acceptably tolerated and immunogenic and deserves further development.
Campbell
James D
JD
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. jcampbel@medicine.umaryland.edu
Edelman
Robert
R
King
James C
JC
Papa
Thomas
T
Ryall
Robert
R
Rennels
Margaret B
MB
D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control*; D004168:Diphtheria Toxoid / Q000008:administration & dosage*; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007273:Injections, Intramuscular; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D008875:Middle Aged; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000008:administration & dosage
D000907:Antibodies, Bacterial; D004168:Diphtheria Toxoid; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate