Phase I study of a lipooligosaccharide-based conjugate vaccine against nontypeable Haemophilus influenzae

Nontypeable Haemophilus influenzae (NTHi) accounts for about one-third of purulent otitis media (OM) in children and is a common cause of pulmonary infection in adults with decreased resistance. Based upon sero-epidemiological data in humans and immunochemical data in laboratory animals, a lipooligo...

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Bibliographic Details
Published in:Vaccine 2003-05, Vol.21 (17), p.2107-2114
Main Authors: Gu, Xin-Xing, Rudy, Susan F, Chu, Chiayung, McCullagh, Linda, Kim, Hung N, Chen, Jing, Li, Jianping, Robbins, John B, Van Waes, Carter, Battey, James F
Format: Article
Language:English
Subjects:
Adult
Animals
Antibodies, Bacterial - blood
Antibody Formation
Bacteriology
Biological and medical sciences
Child
Conjugate vaccine
Drug resistance
Ear diseases
Enzyme-Linked Immunosorbent Assay
Fundamental and applied biological sciences. Psychology
Haemophilus Infections - immunology
Haemophilus influenzae
Haemophilus influenzae - classification
Haemophilus influenzae - immunology
Haemophilus Vaccines - toxicity
Humans
Immunization
Immunoglobulin A - blood
Immunoglobulin G - blood
Immunoglobulin M - blood
Lipooligosaccharide
Lipopolysaccharides - immunology
Mice
Microbiology
Nontypeable Haemophilus influenzae (NTHi)
Otitis media
Otitis Media - immunology
Otitis Media - microbiology
Phase I
Reference Values
Streptococcus infections
Tetanus Toxoid - immunology
Time Factors
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies
Vaccines, Conjugate - toxicity
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Summary:Nontypeable Haemophilus influenzae (NTHi) accounts for about one-third of purulent otitis media (OM) in children and is a common cause of pulmonary infection in adults with decreased resistance. Based upon sero-epidemiological data in humans and immunochemical data in laboratory animals, a lipooligosaccharide (LOS)–tetanus toxoid (TT) conjugate was prepared and evaluated for its safety and immunogenicity in a Phase I study of 40 healthy adults. The conjugate was injected intramuscularly into all volunteers: 28 of them received a second injection 14 weeks later. Local and systemic reactions were monitored and sera, taken before and 2, 6, 14, 16, and 38 weeks after injection, were assayed for IgG, IgA, and IgM antibodies to the LOS by ELISA and for bactericidal activity. The results indicate that there were no significant local or systemic reactions after either injection. All volunteers had pre-existing IgG anti-LOS. The geometric mean (GM) level rose from 14 to 40 at 2 weeks, remained at 35 at 6 weeks (40 or 35 versus 14, P
ISSN:0264-410X
1873-2518
DOI:10.1016/S0264-410X(02)00768-5