Dose escalation, safety and immunogenicity study of a tetravalent meninogococcal polysaccharide diphtheria conjugate vaccine in toddlers

Rennels, Margaret B.; King, James C.; Ryall, Robert; Manoff, Susan B.; Papa, Thomas; Weddle, Andrea; Froeschle, James E.

doi:10.1097/00006454-200210000-00019

Cited by 50 publications

(25 citation statements)

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“…Such studies might then demonstrate whether revaccination with MCC was required once antibody levels declined. With tetravalent conjugate vaccines for serogroups A, C, Y, and W135 nearing licensure (24), the immunogenicity of these vaccines will also need to be investigated for this patient group.…”

Section: Discussionmentioning

confidence: 99%

Immune Response to Meningococcal Serogroup C Conjugate Vaccine in Asplenic Individuals

Balmer¹,

Falconer

McDonald

et al. 2004

Infect Immun

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Asplenic individuals are known to be at increased risk of infection with encapsulated bacteria. Recent United Kingdom recommendations stated that this at-risk group should receive one dose of the meningococcal serogroup C conjugate (MCC) vaccine. However, the immune response of asplenic individuals to MCC vaccine is unknown. The immune response of asplenics (n ‫؍‬ 130) to immunization with the MCC vaccine was investigated. Asplenic individuals had a significantly lower geometric mean titer (GMT) (157.8; 95% confidence interval [CI], 94.5 to 263.3) of bactericidal antibody in serum (SBA) than an age-matched control group (n ‫؍‬ 48) (1448.2; 95% CI, 751.1 to 2792.0). However, 80% of asplenic individuals achieved the proposed protective SBA titer of >8. No differences were observed between the two groups in the serogroup C-specific immunoglobulin G geometric mean concentration. A significant reduction in SBA GMT or the number of responders achieving an SBA titer of >8 was observed if the reason for splenectomy was a medical cause or if MCC vaccination occurred <10 years after splenectomy. Individuals (n ‫؍‬ 29) who did not achieve an SBA titer of >16 were offered a second dose of MCC vaccine. Analysis of the SBA response revealed that 61% (14 of 23) of the individuals who received a second dose achieved a protective titer. In total, 93% of asplenic individuals achieved a titer of >8 following MCC vaccination (one or two doses combined). We recommend that, following vaccination of asplenics, either the level of functional antibody should be determined, with a second dose of MCC vaccine offered to nonresponders, or two doses of MCC vaccine should be routinely offered.Asplenic individuals are at an increased risk of infection from encapsulated bacteria, including Neisseria meningitidis (9, 15). Overwhelming postsplenectomy infection has a high mortality rate, between 40% and 70% (7). Immunization with the 23-valent pneumococcal plain polysaccharide and Haemophilus influenzae type b (Hib) conjugate (29) vaccines is recommended for individuals with functional or anatomic asplenia. In 2001, the United Kingdom Department of Health extended this recommendation to include vaccination with meningococcal serogroup C conjugate (MCC) vaccine, although no data on immune responses are available to date for MCC vaccines in this group (6).Various studies have provided conflicting evidence on the immune response to polysaccharide antigens in asplenic individuals (12, 21), and the limitations of plain polysaccharide vaccines are well documented (13,17,18,29). Meningococcal serogroup C plain polysaccharide vaccines are not immunogenic in those under the age of 2 years (13, 17), and repeated doses can lead to hyporesponsiveness (2,13,18,29). MCC vaccines that have been shown to be highly immunogenic and to generate immune memory in all age groups from infants to adults are now available (10, 25-29). MCC vaccines have been shown to be efficacious in all the age groups targeted during the vaccination campaign initiated in 1999 in the Uni...

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Section: Discussionmentioning

confidence: 99%

Immune Response to Meningococcal Serogroup C Conjugate Vaccine in Asplenic Individuals

Balmer¹,

Falconer

McDonald

et al. 2004

Infect Immun

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“…There are studies of other meningococcal conjugate vaccines that demonstrate solid immunogenicity in infants, immunologic memory, and the booster phenomenon (37,66,97,204,219,220,234,235,(285)(286)(287)(288)(289)356). An exception to this was that one of the earliest serogroup A conjugate vaccines, a bilvalent A/C product, failed to induce immunologic memory, while the C component did, suggesting a failure to elicit a T-cell-dependent response to the group A component of the conjugate vaccine (204,356).…”

Section: Meningococcal Conjugate Vaccines In the United Statesmentioning

confidence: 99%

Prospects for Vaccine Prevention of Meningococcal Infection

2006

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SUMMARY Neisseria meningitidis is the leading cause of bacterial meningitis in the United States and worldwide. A serogroup A/C/W-135/Y polysaccharide meningococcal vaccine has been licensed in the United States since 1981 but has not been used universally outside of the military. On 14 January 2005, a polysaccharide conjugate vaccine that covers meningococcal serogroups A, C, W-135, and Y was licensed in the United States for 11- to 55-year-olds and is now recommended for the routine immunization of adolescents and other high-risk groups. This review covers the changing epidemiology of meningococcal disease in the United States, issues related to vaccine prevention, and recommendations on the use of the new vaccine.

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“…However, other serogroups (A, Y, and W135) will continue to cause problems, and trials with the quadrivalent meningococcal conjugate vaccine have commenced (11,35). Once it is licensed, use of the quadrivalent meningococcal conjugate vaccine in Saudi Arabia will provide long-term protection and will be more cost-effective.…”

Section: Vol 11 2004mentioning

confidence: 99%

Immunologic Hyporesponsiveness to Serogroup C but Not Serogroup A following Repeated Meningococcal A/C Polysaccharide Vaccination in Saudi Arabia

Jokhdar

Borrow

Sultan

et al. 2004

Clin Vaccine Immunol

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Dose escalation, safety and immunogenicity study of a tetravalent meninogococcal polysaccharide diphtheria conjugate vaccine in toddlers

Cited by 50 publications

References 1 publication

Immune Response to Meningococcal Serogroup C Conjugate Vaccine in Asplenic Individuals

Immune Response to Meningococcal Serogroup C Conjugate Vaccine in Asplenic Individuals

Prospects for Vaccine Prevention of Meningococcal Infection

Immunologic Hyporesponsiveness to Serogroup C but Not Serogroup A following Repeated Meningococcal A/C Polysaccharide Vaccination in Saudi Arabia

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