Tetravalent Meningococcal Conjugate Vaccine Research Articles

Safety evaluation of tetravalent meningococcal conjugate vaccine in combination with the inactivated poliomyelitis vaccine and diphtheria-tetanus-acellular pertussis vaccine for infants

Objective: To investigate the safety of the tetravalent meningococcal conjugate vaccine (MPCV-ACYW) in combination with the inactivated poliomyelitis (IPV) vaccine and diphtheria-tetanus-acellular pertussis (DTaP) vaccine for infants aged 3-5 months and provide real-world evidence for the immunization strategy of vaccine combination. Methods: From June to October 2023, a total of 600 3-month-old infants were selected and divided into three groups: control group, mono-vaccination group and combined vaccination group. They were simultaneously or individually vaccinated with MPCV-ACYW, IPV and DTaP vaccines at 3, 4, and 5 months of age, respectively. The incidence rate of adverse reactions within 30 days after each dose was observed. Results: All 600 infants completed at least one vaccination and entered the safety data analysis. The age of the control group (100 infants), the mono-vaccination group (250 infants), and the combination group (250 infants) was (101.20±7.88), (102.26±7.94), and (102.35±7.76) days, respectively. The body lengths were (63.00±3.02), (62.55±3.06), and (63.14±4.02) cm, respectively. The body weights were (6.90±0.77), (6.86±0.94), and (6.99±0.95) kg, respectively. Boys accounted for 49%, 50.4%, and 52.4%, respectively, with no statistically significant differences (all P>0.05). The overall incidence rates of adverse reactions in the control group, mono-vaccination group, and combined vaccination group were 4.00%, 2.80%, and 3.20%, respectively, with systemic adverse reaction rates of 3.00%, 2.40%, and 2.00%. The incidence rates of local adverse reactions were 1.00%, 0.40%, and 1.20%, with no statistically significant differences (all P>0.05). Adverse reactions were mainly grade 1, with incidence rates of grade 1 adverse reactions of 3.00%, 2.00%, and 1.60% in the three groups, and incidence rates of grade 2 adverse reactions of 1.00%, 0.80%, and 1.60%, respectively. No grade 3 or 4 serious adverse reactions occurred, and the differences were not statistically significant (all P>0.05). The adverse reaction symptoms of the three groups were mainly systemic reactions, among which fever and diarrhea symptoms were reported in individual cases in each group, with no statistically significant differences in the incidence rate (all P>0.05). The symptoms of adverse reactions were mostly transient and self-relieved, all of which were cured. Conclusion: The combination of MPCV-ACYW and IPV or DTaP vaccines is safe for infants aged 3-5 months.

Antibodies against Neisseria meningitidis serogroups A, C, W and Y in serum and saliva of Norwegian adolescents

The incidence of invasive meningococcal disease (IMD) among Norwegian 16-19-year-olds was 1-7/100,000 in the decade before the COVID-19 pandemic, with serogroup Y (MenY) dominance. In contrast to many other European countries, meningococcal vaccines are not part of the national immunisation program (NIP) in Norway. This cross-sectional study aimed to measure the degree of natural immunity against Neisseria meningitidis among adolescents in Norway to evaluate the need for introducing tetravalent meningococcal conjugate vaccine (MCV4) in the NIP. Serum and saliva samples were collected from students in upper and lower secondary schools in Norway in 2018. Samples were analysed for meningococcal capsular polysaccharide (PS)-specific antibodies using a bead-based multiplex immunoassay. PS-specific antibody levels were linked to data on meningococcal carriage, vaccination status and risk factors for carriage (assessed with questionnaire) and analysed by linear regression of log transformed concentrations. A subset of samples from unvaccinated individuals was analysed for serum bactericidal antibodies (SBA). A total of 1344 participants, median age 16years (range 12-24), were included in the study. Overall, 60.9% of the participants were female and 1137 (84.6%) were not vaccinated with MCV4. PS-specific antibody concentrations in serum and saliva were low among unvaccinated individuals for all serogroups and only 6.7-20.0% of the subpopulation with high PS-specific antibodies assessed with SBA had protective levels. Unvaccinated MenY carriers had higher levels of MenY anti-PS IgG in serum and IgA in saliva than those not carrying MenY. Use of Swedish snus was associated with lower anti-PS IgG levels in serum and waterpipe use with lower anti-PS IgG levels in saliva. Unvaccinated adolescents in Norway have a low degree of natural immunity against the serogroups of N. meningitidis predominating among cases of IMD in this age group. Therefore, introduction of MCV4 for adolescents in the NIP is recommended.

Lesson learned from an outbreak of invasive meningococcal disease: how HTA could have provided an evidence-based approach for public health response

Abstract During 2015-2016 an outbreak of invasive meningococcal disease due to Neisseria meningitidis serogroup C ST-11 (cc11) occurred in Tuscany, a Region in Central Italy. Sixty-two cases with 13 deaths (13%) were recorded. Regional Authorities responded through a mass immunization campaign targeting all the age groups by offering free of charge a single dose of the tetravalent (ACWY) meningococcal conjugate vaccine or monovalent meningococcal C conjugate (MCC) vaccine. Nevertheless, the response was fragmented and the campaign did not reach the risk-population groups (i.e. men who have sex with men), that were identified only when a Regional outbreak investigation was implemented. Also linkage between cases (i.e. attending the same gay-venue) were identified at a second stage, not allowing prompt max-prophylaxis interventions. In such a situation, an evidence-based approach as Health Technology Assessment, could have informed public health emergency preparedness and response planning processes, i.e. by identifying through early warning alert systems similar ongoing clusters in Europe among specific population-groups and consequently better targeting the immunization campaign. The objective of this presentation is to explore through a practical example how HTA could provide an evidence-based approach for public health response during a real outbreak underlining lesson learned.

Serologic response to meningococcal vaccination in patients with cold agglutinin disease (CAD) in the novel era of complement inhibition

Cold agglutinin disease (CAD) is a rare, potentially life-threatening acquired autoimmune hemolytic anemia characterized by hemagglutination and hemolysis due to immunoglobulin-mediated (usually IgMκ) classic complement pathway activation. Complement inhibition (CI) represents a novel treatment option to control hemolysis. Due to CI patients (pts) are susceptible to encapsulated bacteria e.g. N. meningitidis. Therefore, meningococcal vaccination on CI is mandatory. In this study serologic response to the tetravalent conjugate vaccine Menveo® was analyzed in CAD pts on eculizumab treatment (DECADE trial) using rabbit serum as complement source (rSBA). Protective rSBA titers varied for meningococcal serogroups and over time reflecting an early decline to even non-protective rSBA titers. These data highlight the importance of serologic analyses under chronic CI. Currently, re-vaccination with a tetravalent meningococcal conjugate vaccine every 3 years is recommended on chronic CI. However, re-vaccination on CI might further rely on serologic analyses, implying even early booster vaccinations similar to adults with (functional) asplenia.

Safety of Combination of a Tetravalent Meningococcal Conjugate Vaccine Against Serogroups A, C, Y, W-135 With Other Vaccine Preparations: a Prospective Study of a Series of Cases Among Healthy Children and Children With Various Health Abnormalities

Meningococcal infection is an acute disease caused by Neisseria meningitidis, which proceeds with a diverse clinical aspect from nasopharyngitis to meningococcal meningitis and meningococcemia. Since 2014, a tetravalent meningococcal conjugate vaccine has been registered in Russia. This vaccine creates protection against serogroups A, C, W-135, Y and can be used from the age of nine months to 55 years. The actual issue is a vaccine tolerability, including when combined with other vaccine preparations. Objective: Our aim was to evaluate the safety of a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y and W-135 when it is combined with other vaccine preparations. Methods. A prospective full-design study assessed the tolerability of immunization with a meningococcal conjugate vaccine, both in case of monovaccination and in combination with a pneumococcal 13-valent conjugate vaccine, measles-mumps-rubella, viral hepatitis A, influenza, and chicken pox vaccines. Results. 97 children aged from 9 months to 18 years were vaccinated, 20 of them were healthy and 77 had medical issues (with allergic pathology, ENT diseases, cardiovascular and nervous system diseases, lung diseases as well as orphan diseases). Among vaccinated children, general reactions were observed in 3/97 (3.1%) children, local reactions — in 5 (5.2%). The post-vaccination period passed asymptomatically and uneventfully in the prevailing majority of children vaccinated with a tetravalent meningococcal conjugate vaccine (in 91, 93.8%). Conclusion. The immunization with a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y, W-135 is well tolerated, both in case of monovaccination and in combination with other vaccine preparations, in healthy children of different age groups and in patients with different health status.

Immune Responses in U.S. Military Personnel Who Received Meningococcal Conjugate Vaccine (MenACWY) Concomitantly with Other Vaccines Were Higher than in Personnel Who Received MenACWY Alone.

Immunological responses to vaccination can differ depending on whether the vaccine is given alone or with other vaccines. This study was a retrospective evaluation of the immunogenicity of a tetravalent meningococcal conjugate vaccine for serogroups A, C, W, and Y (MenACWY) administered alone (n = 41) or concomitantly with other vaccines (n = 279) to U.S. military personnel (mean age, 21.6 years) entering the military between 2006 and 2008. Concomitant vaccines included tetanus/diphtheria (Td), inactivated polio vaccine (IPV), hepatitis vaccines, and various influenza vaccines, among others; two vaccine groups excluded Tdap and IPV. Immune responses were evaluated in baseline and postvaccination sera for Neisseria meningitidis serogroups C and Y 1 to 12 months (mean, 4.96 months) following vaccination. Functional antibodies were measured by using a serum bactericidal antibody assay with rabbit complement (rSBA) and by measurement of serogroup-specific immunoglobulin G (IgG) antibodies. The percentage of vaccinees reaching threshold levels (IgG concentration in serum, ≥2 μg/ml; rSBA titer, ≥8) corresponding to an immunologic response was higher postvaccination than at baseline (P < 0.001). Administration of MenACWY along with other vaccines was associated with higher geometric means of IgG concentrations and rSBA titers than those measured 4.60 months after a single dose of MenACWY. In addition, higher percentages of vaccinees reached the immunological threshold (range of odds ratios [ORs], 1.5 to 21.7) and more of them seroconverted (OR range, 1.8 to 4.8) when MenACWY was administered with any other vaccine than when administered alone. Additional prospective randomized clinical trials are needed to confirm the observed differences among groups in the immune response to MenACWY when given concomitantly with other vaccines to U.S. military personnel.

Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP).

In January 2005, a tetravalent meningococcal polysaccharide-protein conjugate vaccine ([MCV4] Menactra, manufactured by Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) was licensed for use among persons aged 11-55 years. CDCns Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of young adolescents (defined in this report as persons aged 11-12 years) with MCV4 at the preadolescent health-care visit (at age 11-12 years). Introducing a recommendation for MCV4 vaccination among young adolescents might strengthen the role of the preadolescent visit and have a positive effect on vaccine coverage among adolescents. For those persons who have not previously received MCV4, ACIP recommends vaccination before high-school entry (at approximately age 15 years) as an effective strategy to reduce meningococcal disease incidence among adolescents and young adults. By 2008, the goal will be routine vaccination with MCV4 of all adolescents beginning at age 11 years. Routine vaccination with meningococcal vaccine also is recommended for college freshmen living in dormitories and for other populations at increased risk (i.e., military recruits, travelers to areas in which meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, patients with anatomic or functional asplenia, and patients with terminal complement deficiency). Other adolescents, college students, and persons infected with human immunodeficiency virus who wish to decrease their risk for meningococcal disease may elect to receive vaccine. This report updates previous reports from ACIP concerning prevention and control of meningococcal disease. It also provides updated recommendations regarding use of the tetravalent meningococcal polysaccharide vaccine (MPSV4) and on antimicrobial chemoprophylaxis.

Immunogenicity and Safety of a Booster Dose of the 10-valent Pneumococcal Haemophilus Influenzae Protein D Conjugate Vaccine Coadministered With the Tetravalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine in Toddlers

This open, randomized clinical trial (NCT00758264) evaluated the coadministration of a booster dose of the 10-valent pneumococcal conjugate vaccine (PHiD-CV) and a single dose of the tetravalent meningococcal conjugate vaccine (MenACWY-TT) in Taiwanese and Mexican toddlers. Healthy toddlers aged 12-23 months (N = 363) were randomized (2:1:1) to receive either both vaccines at first visit, MenACWY-TT at first visit and 1 month later PHiD-CV, or PHiD-CV at first visit and 1 month later MenACWY-TT. Immune responses were measured 1 month after MenACWY-TT vaccination by meningococcal serum bactericidal activity (rSBA) assay and 1 month after PHiD-CV vaccination by pneumococcal 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay. Solicited and unsolicited symptoms were recorded for days 4 and 31 postvaccination, respectively. Serious adverse events were recorded throughout the study. The prespecified criteria for noninferiority of coadministration versus individual administrations were met for all meningococcal serogroups (in terms of percentages of toddlers with rSBA titer ≥8) and all vaccine pneumococcal serotypes (in terms of antibody geometric mean concentration ratios), except pneumococcal serotype 18C. For each meningococcal serogroup, ≥97.5% of toddlers across the 3 groups had rSBA titers ≥128 at 1 month after MenACWY-TT vaccination. For each pneumococcal serotype, at 1 month after PHiD-CV vaccination, ≥96.0% and ≥92.9% of toddlers across the 3 groups had antibody concentrations ≥0.2 µg/mL and opsonophagocytic activity titers ≥8, respectively. The safety profiles of both vaccines when coadministered were clinically acceptable. This study supports the coadministration of PHiD-CV and MenACWY-TT in toddlers.

Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers

Effective vaccines offering broad protection to toddlers, who are at high risk for invasive meningococcal disease, are needed. Here, the immunogenicity, safety and antibody persistence of the tetravalent meningococcal ACWY tetanus toxoid conjugate vaccine (MenACWY-TT) were evaluated in toddlers. Healthy participants aged 12 to 23 mo (n = 304) were randomized (3:1) to receive one dose of MenACWY-TT or a monovalent meningococcal serogroup C conjugate vaccine (MenC-CRM197). Serum bactericidal activity was evaluated with assays using rabbit (rSBA) and human (hSBA) complement up to three years post-vaccination. MenACWY-TT was demonstrated to be non-inferior to MenC-CRM197 in terms of immunogenicity to serogroup C, and the pre-specified immunogenicity criteria for serogroups A, W-135 and Y were met. Exploratory analyses suggested that rSBA geometric mean titers (GMTs), hSBA GMTs and proportions of toddlers with rSBA titers ≥ 1:128 and hSBA titers ≥ 1:4 and ≥ 1:8 were higher for all serogroups at one month post-vaccination with MenACWY-TT compared with MenC-CRM197. At three years post-vaccination, at least 90.8% and 73.6% of MenACWY-TT recipients retained rSBA titers ≥ 1:8 for all serogroups and hSBA titers ≥ 1:4 for serogroups C, W-135 and Y, respectively, but the percentages of toddlers with hSBA titers ≥ 1:4 for serogroup A decreased to 21.8%. In both groups, grade 3 adverse events were infrequently reported and no serious adverse events were considered causally related to vaccination. These results suggest that one single dose of MenACWY-TT induces a robust and persistent immune response and has an acceptable safety profile in toddlers. This study has been registered at www.clinicaltrials.gov NCT00427908.

A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix® in subjects aged 11–17 years: An open, randomised, controlled trial

The co-administration of the tetravalent meningococcal conjugate vaccine, MenACWY-TT, with a licensed hepatitis A and B vaccine, HepA/B (Twinrix(®)), was compared to their separate administration in this open, randomised, controlled study. Healthy subjects 11-17 years of age (n=611) were randomised (3:1:1) to receive both vaccines, MenACWY-TT alone or HepA/B alone. The co-administration of both vaccines was shown to be non-inferior to their individual administration. At seven months after the first vaccination, 99.4-100% of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1% of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity, safety and reactogenicity of either of the vaccines.

Immunogenicity and reactogenicity of co-administered tetanus–diphtheria–acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration

In the United States, co-administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and tetravalent meningococcal conjugate vaccine (MCV4) is recommended in adolescents. In this clinical study, 1341 adolescents received Tdap (Boostrix® GlaxoSmithKline) and MCV4 (Menactra®, Sanofi-Pasteur) simultaneously or sequentially one month apart. Co-administration of Tdap+MCV4 was well tolerated and immunogenic, resulting in high levels of antibodies against diphtheria, tetanus, pertussis and meningococcal serogroup A,C,W-135 and Y antigens. The data provide support for current recommendations for co-administration of Tdap and MCV4 vaccines at the same office visit.

Underinsurance and Adolescent Immunization Delivery in the United States

The goal was to explore the association of being underinsured and receiving doses at a health department clinic (HDC) with not receiving all recommended adolescent vaccine doses. A total of 5657 adolescents, 13 to 17 years of age, were sampled in the National Immunization Survey-Teen in 2006-2007. A total of 63.9% of all adolescents were covered by private health insurance. Among privately insured adolescents, approximately 31.3% were underinsured. Compared with fully insured adolescents, underinsured adolescents were more likely to receive doses at an HDC for tetanus-diphtheria toxoids/tetanus toxoids-reduced diphtheria toxoids-acellular pertussis vaccine (25.1% vs 6.2%; P < .05), tetravalent meningococcal conjugate vaccine (11.5% vs 2.5%; P < .05), and quadrivalent human papillomavirus vaccine (16.2% vs 3.4%; P < .05). Also, compared with fully insured adolescents, underinsured adolescents who received doses at an HDC had lower estimated rates of vaccination coverage for tetanus-diphtheria toxoids/tetanus toxoids-reduced diphtheria toxoids-acellular pertussis vaccine (58.5% vs 70.9%; P < .05), tetravalent meningococcal conjugate vaccine (10.8% vs 25.8%; P < .05), and quadrivalent human papillomavirus vaccine (7.8% vs 14.3%; P < .05). Underinsured adolescents who receive doses at an HDC have lower rates of vaccination coverage than do fully insured adolescents.

Meningococcal tetravalent conjugate vaccine

Background: Neisseria meningitidis is a leading cause of meningitis and sepsis worldwide. Since 1981, a tetravalent meningococcal polysaccharide vaccine has been available in the US but it has been limited to high-risk patients and outbreak settings. In 2005, a tetravalent polysaccharide meningococcal conjugate vaccine (MCV4) was licensed for routine use in the US. Objective: To assess the immunogenicity and safety of MCV4, and to extrapolate the anticipated clinical effectiveness of MCV4 using data from other polysaccharide conjugate vaccination programs. Methods: All published controlled studies of MCV4 immunogenicity, safety and cost-effectiveness are analyzed. Publicly-available clinical trial data and the Advisory Committee on Immunization Practices guidelines were also reviewed. Conclusion: MCV4 is as safe and immunogenic as the previously available polysaccharide vaccine, and seems to provide longer lasting protection against meningococcal disease. Long-term studies are continuing and will shed further light on the effectiveness of MCV4 at the population level.

Using the tetravalent meningococcal polysaccharide-protein conjugate vaccine in the prevention of meningococcal disease

Invasive meningococcal disease occurs worldwide causing an estimated 50,000-135,000 deaths each year in addition to significant sequelae. In developed countries the disease is usually sporadic but outbreaks and epidemics, usually due to serogroups B and C, have occurred. In the US, an increasing number of cases are due to serogroup Y. In developing nations, epidemics due to serogroups A and more recently W-135, are common. The tetravalent meningococcal conjugate vaccine to serogroups A, C, Y, and W-135 (MCV4) has been demonstrated to be highly immunogenic and promote immune memory. This article will describe the rationale for the vaccine and its potential role to significantly decrease mortality and morbidity of meningococcal disease in those areas and populations at greatest risk from these serogroups.

Use of Meningococcal Vaccines in the United States

In January 2005, Food and Drug Administration licensed a new tetravalent (serogroups A, C, Y, W-135) meningococcal conjugate vaccine ([MCV4] Menactra) for use in persons 11-55 years of age. In February 2005, CDC's Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination of adolescents and college freshmen living in dormitories with MCV4. The manufacturer started shipments of MCV4 in March 2005. MCV4 should become a key addition to existing meningococcal disease prevention measures.

Physician Perspectives to Inform a New Recommendation for Meningococcal Conjugate Vaccine (MCV4)

In January 2005, the U.S. Food and Drug Administration licensed a new tetravalent meningococcal conjugate vaccine (MCV4). Before any policy decisions by the U.S. Advisory Committee on Immunization Practices (ACIP) related to MCV4, the Centers for Disease Control and Prevention requested a study to explore the perspective of primary care physicians regarding different recommendation scenarios for use of MCV4. Cross-sectional mail survey of a national random sample of pediatricians (PDs) and family physicians (FPs), conducted January 2005. Respondents chose from four MCV4 recommendation scenarios in terms of ability to implement, perceived patient/parent preferences, scientific evidence, and overall best fit. Response rate to the single-mailing survey was 57%. In terms of ability to implement, respondents generally preferred an MCV4 recommendation targeted to middle-school entry (11-12 years old) or with the Td booster at any age, but on the basis of scientific evidence they favored MCV4 at high school completion. For "overall best fit," relatively equal proportions of respondents favored a recommendation at middle school entry and one linked to Td booster administration (whenever it occurred); there were no significant differences between PDs and FPs. Major influences on willingness to recommend MCV4 were vaccine safety/side effects and insurance coverage/reimbursement. Support for an MCV4 recommendation at middle school entry is common but not universal among primary care providers. Data suggest that respondents appreciate the potential discrepancy between practical aspects of vaccine delivery and the need to protect those adolescents at greatest risk of disease. Respondents' preferences for the overall best fit appear to prioritize ease of implementation over epidemiologic patterns.

Meningococcal conjugate vaccines: efficacy and new combinations

Meningococcal disease continues to be a serious public health concern, being associated with high morbidity and mortality rates worldwide, particularly in Brazil. In addition to discussing recent changes in the global epidemiology of meningococcal disease, we also analyze the development and impact of new conjugate vaccines on the prevention of meningococcal disease, with emphasis on the different immunization strategies implemented with these vaccines. MEDLINE databases were searched from 1996 to 2006, with emphasis on review articles, clinical trials and epidemiological studies. Information was also sought on the Centers for Disease Control and Prevention, Brazilian Ministry of Health and Centro de Vigilância Epidemiológica do Estado de São Paulo websites. Five serogroups (A, B, C, W135 and Y) are responsible for virtually all cases of the disease worldwide, with marked regional and temporal differences. The new meningococcal serogroup C conjugate vaccines (MCC) offer unmistakable advantages over polysaccharide vaccines. MCC vaccines generate a more efficient and long-lasting antibody response, inducing immunologic memory and reduction of nasopharyngeal carriage. The immediate results of introducing these vaccines into immunization programs have been encouraging, with a dramatic reduction in the incidence of serogroup C disease, not only in vaccinated, but also in unvaccinated individuals (herd immunity). However, concerns have arisen regarding the long-term effectiveness of these vaccines, especially for infants vaccinated in the routine schedule. The reported waning of efficacy more than 1 year after routine infant immunization supports alternative schedules incorporating a booster dose of MCC vaccine given at 12-18 months of age, in order to maintain long-term protection. The recent licensure of the tetravalent meningococcal conjugate vaccine represents, at last, a real possibility of a broader protection against meningococcal disease, although the need to develop an effective vaccine against serogroup B remains.

Update on Prevention of Meningococcal Disease: Focus on Tetravalent Meningococcal Conjugate Vaccine

To review the immunogenicity, efficacy, safety, and new recommendations for routine use of the tetravalent meningococcal conjugate vaccine (MCV4). A MEDLINE search (1966-June 2005) was conducted using the key words Neisseria meningitidis and meningococcal vaccines for clinical trials limited to human research published in the English language. Randomized, controlled, multicenter trials were reviewed and included to evaluate the safety and efficacy of MCV4. Additional open-label trials on the use of MCV4 in children less than 24 months of age are included since these studies may be used to support the approval of the vaccine for use in children. Literature on epidemiology and pathology of meningococcal meningitis and the Advisory Committee on Immunization Practices (ACIP) recommendations were also reviewed. MCV4 is approved for active immunization of adolescents and adults between the ages of 11 and 55 years for the prevention of disease caused by N. meningitidis serogroups A, C, Y, and W-135. MCV4 has been shown to have comparable immunogenicity and a similar adverse reaction profile to the tetravalent meningococcal polysaccharide vaccine (MPSV4). It is expected that MCV4 will provide a longer duration of protection from meningococcal disease than MPSV4. Based on lished immunogenicity, efficacy, and safety data, as well as the recent recommendations by the ACIP for its routine use, MCV4 is the preferred meningococcal vaccine for persons between 11 and 55 years of age and should be included on pharmacy formularies.

Recent trends in meningococcal epidemiology and current vaccine recommendations

In 2005, a new meningococcal vaccine, tetravalent meningococcal conjugate vaccine (MCV4) was approved for use. This review discusses the population for whom it is recommended and the logic underlying these recommendations. The older meningococcal vaccine, composed of capsular polysaccharide, had limited use in civilian populations. The Centers for Disease Control and the American Academy of Pediatrics now recommend the routine vaccination of adolescents with MCV4. This recommendation is largely based on newer epidemiologic data showing a considerable risk of meningococcal disease in late adolescence, most of which is preventable with vaccine. The new MCV4 vaccine should be used in primary-care practices for the immunization of all adolescents and high-risk children and adults. In the future, further studies are likely to show it to be safe and effective for younger children too.

Immunizations, neonatal jaundice, and animal-induced injuries

To concisely review data published over the past year on three topics pertinent to the practicing pediatrician: immunizations, neonatal jaundice, and animal-induced injuries. Updates on immunizations, including varicella and pneumococcus in the post-vaccine era, use of a polyvalent conjugated meningococcal vaccine, and influenza vaccination during a vaccine shortage are discussed. Mortality and morbidity from varicella, and risk of invasive disease from pneumococcal infections have declined. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention released guidelines for the use of a tetravalent meningococcal conjugate vaccine in adolescents 11 years and older. Infants at younger gestational age are at higher risk for developing hyperbilirubinemia. The American Academy of Pediatrics has released new guidelines emphasizing breastfeeding, systematic pre-discharge assessment for risk factors, early follow-up and intervention. Use of home nursing services in the postnatal period is cost-effective. Although the incidence of rabies is low, many receive postexposure prophylaxis. Spider bites cause fewer systemic effects in children than adults. Pet reptile carriage of salmonella necessitates handwashing after handling of animals. Recommendations for adolescent meningococcal vaccination, and the impact of varicella and pneumococcal immunization on our communities reflect an evolution in our management of infectious diseases. The latest practice guidelines on hyperbilirubinemia emphasize close follow-up of all newborns after postpartum discharge and even more careful evaluation of those infants near term. Education on rabies prophylaxis, spider bites, and salmonella from pet reptiles should focus on judicious use of resources and the proper handling of pets.