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PubMed2002

Meningococcal disease: treatment and prevention.

Many countries have been experiencing a significant increase in meningococcal disease. With the strains currently circulating, septicaemia is now a more frequent manifestation than meningitis and early recognition of disease manifestations by patient, parent or physician as well as early recognition of disease severity are the most important factors in attempting to reduce mortality and morbidity. Ceftriaxone is the treatment of choice but must be accompanied by aggressive supportive therapy in those with severe disease. The role of steroids is unknown. The evidence to support their use in both meningitis and severe systemic sepsis is discussed. The purified polysaccharide vaccines that have been available for some years may play a limited role in disease prevention. The recently introduced conjugate vaccine for preventing serogroup C disease represents a major advance but no vaccine is currently available to prevent serogroup B disease, cases of which will continue to challenge clinical practice.

Anti-Bacterial Agents↗
PubMed2026

Safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in USA and Puerto Rico: Results from a Phase III, randomized, active-controlled study.

MenACYW-TT, a quadrivalent meningococcal tetanus toxoid-conjugate vaccine, is approved for prevention of invasive meningococcal disease in infants ≥ 6 weeks of age in the USA. This Phase III study (NCT03673462; September 17, 2018 - March 16, 2023) evaluated the safety of MenACYW-TT compared with a licensed quadrivalent meningococcal oligosaccharide diphtheria CRM197-conjugate vaccine (MenACWY-CRM) when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in a four-dose series (3+1 schedule). Participants were randomized 3:1 to receive MenACYW-TT (Group 1; n = 2080) or MenACWY-CRM (Group 2; n = 697) at 2, 4, 6, and 12 months of age, with concomitant administration of routine pediatric vaccines (DTaP5-IPV/Hib, PCV13, rotavirus, hepatitis B, MMR, and varicella vaccines). Safety assessments included immediate unsolicited adverse events within 30 minutes post-vaccination, solicited injection site and systemic reactions within 7d, unsolicited AEs within 30d, serious adverse events (SAEs) including adverse events of special interest (AESIs), and medically attended adverse events (MAAEs) throughout the study. MenACYW-TT and MenACWY-CRM were overall well tolerated, and safety profiles were comparable. Solicited injection site reactions occurred in 84.9% and 84.6% of participants in Groups 1 and 2, respectively; solicited systemic reactions in 87.1% and 88.2%, respectively. During the entire study, 5.2% in Group 1 and 3.0% in Group 2 experienced at least one SAE; 0.9% and 0.1%, respectively, reported at least one AESI. Three deaths occurred in Group 1. All SAEs, AESIs, and deaths were unrelated to study vaccines. This study supports the safety profile of MenACYW-TT in infants and toddlers aged ≥ 6 weeks.Study registration: Clinicaltrials.gov: NCT03673462; EudraCT: 2019-004459-35.

Child, Preschool↗
PubMed1999

Meningococcal serogroup C conjugate vaccine is immunogenic in infancy and primes for memory.

The safety, immunogenicity, and immunologic priming of 2 dosages (2 microgram or 10 microgram) of a meningococcal C oligosaccharide-CRM197 conjugate vaccine was evaluated in 114 infants vaccinated at ages 2, 3, and 4 months. Antibody persistence and response to boosting with 10 microgram of meningococcal C polysaccharide were assessed. The meningococcal conjugate vaccine produced fewer local reactions than concurrent routine immunizations. Total serogroup C-specific immunoglobulin geometric mean concentration (GMC) increased from 0.3 microgram/mL before vaccination to 13.1 microgram/mL at age 5 months. Serum bactericidal antibody (SBA) geometric mean titers (GMTs) rose from <1:4 to 1:1057 at 5 months and fell by 14 months to 1:19. Following boosting, anti-C-specific immunoglobulin GMC rose to 15.9 microgram/mL and SBA GMT to 1:495. Antibody responses in the 10-microgram dose cohort were significantly higher at 5 months (P<.01) than in the 2-microgram dose cohort but were lower after polysaccharide boosting (P=.02). This meningococcal conjugate vaccine was well tolerated and immunogenic and induced immunologic memory in infants.

Bacterial Capsules↗
PubMed2001

Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System.

Recent recommendations by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may lead to the increased use of the meningococcal polysaccharide vaccine. The Vaccine Adverse Event Reporting System (VAERS) is useful for the detection of previously unrecognized reactions and for the monitoring of known reactions. Limitations of VAERS include underreporting and the inability to establish a causal relationship between vaccination and adverse events in most cases. From July 1990 through 31 October 1999, 110 adverse events were reported after receipt of meningococcal vaccine alone. Thirteen (12%) were serious, including 6 injection site reactions, 3 allergic reactions, 1 case of Guillain-Barré syndrome, and 3 miscellaneous events. Fever (30%), headache (17%), dizziness (15%), injection site hypersensitivity (13%), urticaria (12%), and paresthesia (10%) were among the most common events reported. Fever and injection site and allergic reactions are most likely causally linked to the vaccine. That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine.

Consumer Product Safety↗
PubMed2001

Meningococcal disease and travel.

Invasive meningococcal disease, in both endemic and epidemic forms, is the cause of significant morbidity and mortality worldwide. Despite all advances in therapy, the fatality rate of meningococcal meningitis remains unacceptably high, between 5% and 10%, and a similar proportion suffers long-term neurological sequalae. Prevention of this rapidly fatal disease is of paramount importance. The use of the available internationally licensed meningococcal vaccines would be indicated for individuals with medical conditions that increase the risk of the disease and for travelers to high-risk countries. In the last 2 years, there has been a shift in the epidemic pattern of meningococcal disease during the Hajj (pilgrimage) season, with predominance of Neisseria meningitidis serogroup W135. Recent changes have been made in the policy issued by the Saudi Ministry of Health (Riyadh, Saudi Arabia), which requires visitors from all over the world arriving for purposes of umra and Hajj to show evidence of vaccination against meningitis with the quadrivalent meningococcal vaccine.

Global Health↗
PubMed2002

Meningococcal disease among United States military service members in relation to routine uses of vaccines with different serogroup-specific components, 1964-1998.

Historically, military recruits have been at high risk of acquiring meningococcal disease. Beginning in the 1940s, the US military relied on mass treatment with sulfadiazine to control outbreaks in training camps. In the 1960s, a vaccine was developed in response to the emergence of sulfadiazine-resistant strains. Since 1971, all new recruits in the US military have been immunized against Neisseria meningitidis during their first days of service. Serogroups represented in vaccines given to service members have changed over time: the quadrivalent (A, C, Y, W135) vaccine has been given since 1982. In the US military, meningococcal disease rates decreased by approximately 94% from 1964 to 1998. After initiating routine immunization in 1971, crude rates decreased sharply and have remained low; in addition, there have been few cases of disease caused by serogroups represented in contemporaneously administered vaccines. In the US military, immunizations have been effective for the prevention of disease caused by vaccine-homologous serogroups of N. meningitidis.

Hospitalization↗
PubMed2002

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.

Adult↗
PubMed2003

Immunogenicity and immunological priming of the serogroup a portion of a bivalent meningococcal A/C conjugate vaccine in 2-year-old children.

Two-year-old children were vaccinated with 1 dose of meningococcal A/C conjugate (MACC) or meningococcal A/C polysaccharide (MACP) vaccine. Meningococcal serogroup A (MenA)-specific IgG geometric mean avidity indices (GMAIs) increased 1 month after vaccination with MACC (GMAI, 210; 95% confidence interval [CI], 140-300) and MACP (GMAI, 190; 95% CI, 120-310). One year after vaccination, the GMAI of the MACP-vaccinated cohort decreased to 130 (95%, CI 100-170), but a constant GMAI was maintained in the MACC-vaccinated cohort (210; 95% CI, 140-300), despite declining MenA-specific IgG antibody levels.

Antibodies, Bacterial↗
PubMed2003

Neisseria meningitidis carriage during an outbreak of serogroup C disease.

During 2001, an outbreak of serogroup C meningococcal disease led to immunization of individuals aged 13-29 years in Abbotsford, British Columbia, Canada. This study addresses the distribution of Neisseria meningitidis carriage in this population and the implications of that distribution for the targeting of the immunization campaign. Pharyngeal swabs were obtained at immunization from 2004 people. Colonies were identified and serogrouped using standard agglutination methods and by PCR. Isolates were characterized using pulsed-field gel electrophoresis (PFGE). The prevalence of N. meningitidis carriage was 153 carriers per 2004 subjects (7.6%; 95% confidence interval, 6.5%-8.9%). Only 6 (4%) of the isolates from these carriers were found to be serogroup C by agglutination or PCR testing, and all of these were from individuals within the age group targeted for immunization. Only 1 of these 6 isolates was found to be identical to the outbreak strain by PFGE. The observation that a virulent strain is not circulating widely suggests the possibility of low background immunity in the population at risk and emphasizes the importance of vaccination in controlling epidemic group C meningococcal disease.

Adolescent↗
PubMed2003

Antibody to genome-derived neisserial antigen 2132, a Neisseria meningitidis candidate vaccine, confers protection against bacteremia in the absence of complement-mediated bactericidal activity.

Genome-derived neisserial antigen 2132 (GNA2132) is a novel vaccine candidate that was identified during the Neisseria meningitidis group B strain MC58 genome-sequencing project. To assess the vaccine potential of GNA2132, we prepared antisera from mice immunized with recombinant GNA2132 (gene from strain NZ394/98). Anti-GNA2132 antibody bound to the surface of live bacteria from all 7 capsular group B or C strains tested and elicited deposition of human C3b on the bacterial surface. However, with human or infant-rat complement, anti-GNA2132 had no detectable bactericidal activity (titer, <1:4) against the nominal strain, NZ394/98, and was bactericidal against only 2 of the other 6 strains tested. These differences between strains were unrelated to GNA2132 amino acid sequence or level of protein expression. Despite lack of bactericidal activity, anti-GNA2132 antiserum passively protected infant rats against meningococcal bacteremia after challenge with all 5 resistant strains. GNA2132 is thus a promising vaccine candidate for prevention of disease caused by N. meningitidis.

Amino Acid Sequence↗
PubMed2004

The impact of meningococcal serogroup C conjugate vaccine in Scotland.

The increasing number of cases of serogroup C meningococcal disease in Scotland in the late 1990s coincided with the availability of a new meningococcal conjugate serogroup C (MCC) vaccine that, from 1999 onwards, was offered to all individuals aged <20 years. Annual incidence rates between 1994 and 2003 were calculated in 3 age groups (<5 years old; 5-19 years old; and >or=20 years old), and Poisson regression models were used to verify disease trends over time. Dramatic reductions (P<.05) in the incidence of serogroup C meningococcal disease were seen in target age groups: from 15.8 incidents per 100,000 subjects in 1999 (95% confidence interval [CI], 11.3-20.3) to 0.7 incidents per 100,000 subjects in 2001 (95% CI, -0.3 to 1.6), for subjects <5 years old, and from 6.7 incidents per 100,000 subjects in 1999 (95% CI, 5.1-8.3) to 1.5 incidents per 100,000 subjects in 2001 (95% CI, 0.7-2.3), for subjects 5-19 years old. An increasing incidence of serogroup B meningococcal disease in individuals 5-19 years old was clearly established before the campaign began. A 30% decrease in the case-fatality rate for individuals <20 years old was not significant (P=.1598). The MCC vaccine program has been highly effective in Scotland, leading to substantial reductions in serogroup C meningococcal disease and meningococcal mortality, with no adverse effects on other groups.

Adolescent↗
PubMed2005

Effectiveness of serogroup C meningococcal polysaccharide vaccine: results from a case-control study in Quebec.

BACKGROUND: After a mass-immunization campaign in the province of Quebec, Canada, from 1992 to 1993, a case-control study was conducted to evaluate the effectiveness of the polysaccharide vaccine, while controlling for the potential confounding effects of selected risk factors for serogroup C meningococcal disease. METHODS: The case patient group comprised 74 individuals with confirmed serogroup C meningococcal disease reported after the beginning of the campaign until 31 March 1998. Four control subjects, matched for age and place of residence, were randomly selected from the Quebec health insurance registry. Information on case patients was obtained from regional public health departments. Case patients and control subjects (or a family member) were interviewed by telephone. The analyses were conducted by using conditional logistic regression models. RESULTS: Although the 95% confidence intervals (CIs) were large as a result of the small sample sizes, a high level of protection was found among children aged >or=6 years, during the first 2 years after vaccination (vaccine effectiveness, 95%; 95% CI, 68%-99%; P<.002), and protection remained high during the following 3 years (77%; 95% CI, -364% to 99%; P=.34). For children aged 2-5 years, the estimated effectiveness was positive during the first 2 years (62%; 95% CI, -403% to 97%; P=.47) but was negative during the following period (-74%; 95% CI, -1956% to 85%; P=.66). Among children aged <2 years, there was no evidence of protection. Household crowding and disadvantaged socioeconomic conditions were associated with increased risk of disease. CONCLUSIONS: The polysaccharide vaccine remains a cost-effective option for the short-term protection of school-aged children and adults; however, conjugate vaccines are needed for younger children.

Adult↗
PubMed2005

Protective antibody responses elicited by a meningococcal outer membrane vesicle vaccine with overexpressed genome-derived neisserial antigen 1870.

Background. Meningococcal outer membrane vesicle (OMV) vaccines are efficacious in humans but have serosubtype-specific serum bactericidal antibody responses directed at the porin protein PorA and the potential for immune selection of PorA-escape mutants.Methods. We prepared an OMV vaccine from a Neisseria meningitidis strain engineered to overexpress genome-derived neisserial antigen (GNA) 1870, a lipoprotein discovered by genome mining that is being investigated for use in a vaccine.Results. Mice immunized with the modified GNA1870-OMV vaccine developed broader serum bactericidal antibody responses than control mice immunized with a recombinant GNA1870 protein vaccine or an OMV vaccine prepared from wild-type N. meningitidis or a combination of vaccines prepared from wild-type N. meningitidis and recombinant protein. Antiserum from mice immunized with the modified GNA1870-OMV vaccine also elicited greater deposition of human C3 complement on the surface of live N. meningitidis bacteria and greater passive protective activity against meningococcal bacteremia in infant rats. A N. meningitidis mutant with decreased expression of PorA was more susceptible to bactericidal activity of anti-GNA1870 antibodies.Conclusions. The modified GNA1870-OMV vaccine elicits broader protection against meningococcal disease than recombinant GNA1870 protein or conventional OMV vaccines and also has less risk of selection of PorA-escape mutants than a conventional OMV vaccine.

Animals↗
PubMed2006

Antibody persistence 3 years after immunization of adolescents with quadrivalent meningococcal conjugate vaccine.

BACKGROUND: A quadrivalent meningococcal conjugate vaccine (MCV-4) is recommended for United States teenagers. The duration of protective immunity is unknown. We investigated serum antibody persistence 3 years after vaccination of adolescents. METHODS: Serum samples from participants of a randomized trial who had received MCV-4 (n=52) or polysaccharide vaccine (MPSV-4; n=48) and from unvaccinated controls (n=60) were assayed for serogroups C, W-135, and Y anticapsular antibody concentrations by use of a radioantigen binding assay and for bactericidal activity (in a human complement assay) and passive protection against serogroup C bacteremia in an infant rat model. RESULTS: A higher proportion of participants in the vaccine groups had protective bactericidal titers (> or =1 : 4), compared with that in the control group (for MCV-4 recipients vs. controls, P<.01; for MPSV-4 recipients vs. controls, P< or =.06). More MCV-4 recipients had W-135 bactericidal titers > or =1 : 4 than did MPSV-4 recipients (P=.01). More MCV-4 recipients had passive protective activity against serogroup C bacteremia than did MPSV-4 recipients (76% vs. 49%; P<.01). The differences in protective activity were largest between participants in the vaccine groups with bactericidal titers <1 : 4 (63% protective in MCV-4 recipients vs. 31% protective in MPSV-4 recipients; P=.01). CONCLUSIONS: Compared with MPSV-4, MCV-4 elicited greater persistence of antibody activity against serogroups C and W-135 at 3 years after vaccination in adolescents. On the basis of passive protection data in an infant rat model, bactericidal titers > or =1 : 4 underestimate protective immunity.

Animals↗
PubMed2006

Serogroup C meningococcal glycoconjugate vaccine in adolescents: persistence of bactericidal antibodies and kinetics of the immune response to a booster vaccine more than 3 years after immunization.

BACKGROUND: The persistence of protection from meningococcal disease following immunization with serogroup C meningococcal (MenC) glycoconjugate vaccines in infancy is short-lived. The duration of protective immunity afforded by these vaccines in other at-risk age groups (i.e., adolescents and young adults) is not known. We evaluated the persistence of bactericidal antibodies following immunization with a MenC glycoconjugate vaccine (MenCV) in adolescents and the kinetics of immune response to a meningococcal AC plain polysaccharide vaccine (MenPS) challenge or a repeat dose of MenCV. METHODS: We conducted a randomized comparative trial of 274 healthy 13-15-year-olds from whom a total of 4 blood samples were obtained (prior to administration of a dose of MenPS or MenCV, again on 2 further occasions at varying times from days 2-7 after vaccination, and finally on day 28 after vaccination. The correlate of protection was a serum bactericidal assay titer > or = 8 (with a serum bactericidal assay using human complement). RESULTS: A serum bactericidal assay using human complement titer > or = 8 was observed in 75% of participants at baseline (mean age, 14.5 years; mean time since routine MenCV vaccination, 3.7 years). No increase in serum bactericidal assay geometric mean titers was detected until day 5 after administration of MenPS. Geometric mean titers following administration of MenCV were significantly higher than those observed following administration of MenPS, at days 5, 7, and 28. CONCLUSIONS: This study showed sustained levels of bactericidal antibodies for at least 3 years after immunization of adolescents with MenCV. After challenge of immunized adolescents with MenPS, there was no increase in serum bactericidal assay observed until day 5 after vaccination, indicating that immunological memory may be too slow to generate protection against this potentially rapidly invasive organism.

Adolescent↗