Safety and immunogenicity of a serogroups A/C Neisseria meningitidis oligosaccharide-protein conjugate vaccine in young children: A randomized controlled trial

JAMA

Volumn 275, Issue 19, 1996, Pages 1499-1503

  Lieberman, Jay M ^a,e   Chiu, Susan S ^a,d   Wong, Victor K ^b   Partridge, Susan ^a   Chang, Swei Ju ^a   Chiu, Chung Yin ^a,d   Gheesling, Linda L ^c   Carlone, George M ^c   Ward, Joel I ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b KAISER PERMANENTE   (United States)

^c NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES   (United States)

^d UNIVERSITY OF HONG KONG   (Hong Kong)

^e HARBOR UCLA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL PROTEIN; BACTERIAL VACCINE; OLIGOSACCHARIDE; POLYSACCHARIDE VACCINE;

ANTIBODY RESPONSE; APPETITE DISORDER; ARTICLE; BACTERIAL MENINGITIS; CHILD; CLINICAL ARTICLE; DROWSINESS; DRUG CONJUGATION; DRUG EFFECT; DRUG SAFETY; DRUG SCREENING; HUMAN; IMMUNOGENICITY; NEISSERIA MENINGITIDIS; PRIORITY JOURNAL; SERUM BACTERICIDAL ACTIVITY; VOMITING;

EID: 0029875330     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.275.19.1499     Document Type: Article

References (33)

1. Schwartz B, Moore PS, Broome CV. Global epidemiology of meningococcal disease. Clin Microbiol Rev. 1989;2:S118-S124.
2. Jackson LA, Schuchat A, Reeves MW, Wenger JD. Serogroup C meningococcal outbreaks in the United States: an emerging threat. JAMA. 1995; 273:383-389.
3. Whalen CM, Hockin JC, Ryan A, Ashton F. The changing epidemiology of invasive meningococcal disease in Canada, 1985 through 1992: emergence of a virulent clone of Neisseria meningitidis. JAMA. 1995;273:390-394.
4. Pinner RW, Gellin BG, Bibb WF, et al. Meningococcal disease in the United States - 1986. J Infect Dis. 1991;164:368-374.
5. Constantino P, Viti S, Podda MA, Velmonte MA, Nencioni L, Rappuoli R. Development and phase I clinical testing of a conjugate vaccine against meningococcus A and C. Vaccine. 1992;10:691-698.
6. Anderson EL, Bowers T, Mink CM, et al. Safety and immunogenicity of meningococcal polysaccharide conjugate vaccine in adults. Infect Immun. 1994;62:3391-3395.
7. Carlone GM, Frasch CE, Siber GR, et al. Multicenter comparison of levels of antibody to the Neisseria meningitidis group A capsular polysaccharide measured by using an enzyme-linked immunosorbent assay. J Clin Microbiol. 1992;30:154-159.
8. Gheesling LL, Carlone GM, Pais LB, et al. Multicenter comparison of Neisseria meningitidis serogroup C anti-capsular polysaccharide antibody levels by a standardized enzyme-linked immunosorbent assay. J Clin Microbiol. 1994;32:1475-1482.
9. Holder PK, Maslanka SE, Pais LB, Dykes J, Plikaytis BD, Carlone GM. Assignment of Neisseria meningitidis serogroup A and C class-specific anticapsular antibody concentrations to the new reference serum CDC1992. Clin Diag Lab Immunol. 1995;2:132-137.
10. Jackson LA, Wenger JD. Laboratory-based surveillance for meningococcal disease in selected areas: United States, 1989-1991. MMWR Morb Mortal Wkly Rep. 1993;42:21-30.
11. Graham DR, Letourneau BE, Chaudhary S, et al. Organization of a program for community-wide meningococcal immunization following an outbreak. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 1995; San Francisco, Calif. Abstract K164.
12. MacDonald K, Hennessy T, Osterholm M, et al. A communitywide outbreak of serogroup C meningococcal disease with a unique epidemiologic pattern. In: Programs and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 1995; San Francisco, Calif. Abstract K160.
13. Goldschneider I, Lepow ML, Gotschlich EC, et al. Immunogenicity of group A and group C meningococcal polysaccharides in human infants. J Infect Dis. 1973;128:769-776.
14. Kayhty H, Karanko V, Peltola H, et al. Serum antibodies to capsular polysaccharide vaccine of group A Neisseria meningitidis followed for three years in infants and children. J Infect Dis. 1980; 142:861-868.
15. Goldschneider I, Lepow ML, Gotschlich EC. Immunogenicity of the group A and group C meningococcal polysaccharides in children. J Infect Dis. 1972;125:509-519.
16. Ceesay SJ, Allen SJ, Menon A, et al. Decline in meningococcal antibody levels in African children 5 years after vaccination and the lack of an effect of booster immunization. J Infect Dis. 1993;167:1212-1216.
17. Peltola H, Makela PH, Kayhty H, et al. Clinical efficacy of meningococcus group A capsular polysaccharide vaccine in children three months to five years of age. N Engl J Med. 1977;97:686-691.
18. Wahdan MH, Rizk F, El-Akkad AM, et al. A controlled field trial of a serogroup A meningococcal polysaccharide vaccine. Bull World Health Organ. 1973;48:667-673.
19. Reingold AL, Broome CV, Hightower AW, et al. Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine. Lancet. 1985;2:114-118.
20. Gold R, Lepow ML, Goldschneider I, et al. Kinetics of antibody production to group A and group C meningococcal polysaccharide vaccines administered during the first six years of life: prospects of routine immunization of infants and children. J Infect Dis. 1979;140:690-697.
21. Artenstein MS, Gold R, Zimmerly JG, et al. Prevention of meningococcal disease by group C polysaccharide vaccine. N Engl J Med. 1970;282: 417-420.
22. Taunay A de E, Galvao PA, de Morais JS, et al. Disease prevention by meningococcal C polysaccharide vaccine in preschool children: results after eleven months in Sao Paulo, Brazil. Pediatr Res. 1974;8:429. Abstract.
23. Stein KE. Thymus-independent and thymus-dependent responses to polysaccharide antigens. J Infect Dis. 1992;165(suppl 1):S49-S52.
24. Schlesinger Y, Granoff DM, and the Vaccine Study Group. Avidity and bactericidal activity of antibody elicited by different Haemaphilus influenzae type b conjugate vaccines. JAMA. 1992;267: 1489-1494.
25. Hetherington SV, Lepow ML. Correlation between antibody affinity and serum bactericidal activity in infants. J Infect Dis. 1992;165:753-756.
26. Amir J, Scott MG, Nahm MH, Granoff DM. Bactericidal and opsonic activity of IgG1 and IgG2 anticapsular antibodies to Haemophilus influenzae type b. J Infect Dis. 1990;162:163-171.
27. Goldshneider I, Gotschlich E, Artenstein MS. Humoral immunity to the meningococcus, I: the role of humoral antibodies. J Exp Med. 1969;129: 1307-1326.
28. Milagres LG, Ramos SR, Sacchi CT, et al. Immune response of Brazilian children to a Neisseria meningitidis serogroup B outer membrane protein vaccine: comparison with efficacy. Infect Immun. 1994;62:4419-4424.
29. Takala AK, Eskola J, Leinonen M, et al. Reduction of oropharyngeal carriage of Haemophilus influenzae type b (Hib) in children immunized with an Hib conjugate vaccine. J Infect Dis. 1991;164: 982-986.
30. Murphy TV, Pastor P, Medley F, Osterholm MT, Granoff DM. Decreased Haemophilus colonization in children vaccinated with Haemophilus influenzae type b conjugate vaccine. J Pediatr. 1993;122:517-623.
31. Twumasi PA Jr, Kumah S, Leach A, et al. A trial of a group A plus group C meningococcal polysaccharide-protein conjugate vaccine in African infants. J Infect Dis. 1995;171:632-638.
32. Finne J, Leinonen M, Makela PH. Antigenic similarities between brain components and bacteria causing meningitis. Lancet. 1983;2:355-357.
33. Romero JD, Outschoorn IM. Current status of meningococcal group B vaccine candidates: capsular or noncapsular? Clin Microbiol Rev. 1994;7:559-575.