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Expert Review of Vaccines May 2016Adolescents have the highest rates of meningococcal carriage and transmission. Interrupting the adolescent habitat in order to reduce carriage and transmission within... (Review)
Review
Adolescents have the highest rates of meningococcal carriage and transmission. Interrupting the adolescent habitat in order to reduce carriage and transmission within adolescents and to other age groups could help to control meningococcal disease at a population level. Compared to immunization strategies restricted to young children, a strategy focused on adolescents may have more profound and long-lasting indirect impacts, and may be more cost effective. Despite challenges in reaching this age-group, experience with other vaccines show that high vaccine coverage of adolescents is attainable.
Topics: Adolescent; Carrier State; Disease Transmission, Infectious; Humans; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis
PubMed: 26651380
DOI: 10.1586/14760584.2016.1130628 -
The Pediatric Infectious Disease Journal Oct 2020Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW-TT) could offer protection against invasive meningococcal disease in this population. This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM).
METHODS
Healthy children 2-9 years of age in the United States, including Puerto Rico, were randomized (1:1) to receive MenACYW-TT (n = 499) or MenACWY-CRM (n = 501) (NCT03077438). Meningococcal antibody titers to the 4 vaccine serogroups were measured using a serum bactericidal antibody assay with human complement (hSBA) before and at day 30 after vaccination. Noninferiority between the vaccine groups was assessed by comparing seroresponse rates (postvaccination titers ≥1:16 when prevaccination titers were <1:8, or ≥4-fold increase if prevaccination titers were ≥1:8) to the 4 serogroups at day 30. Safety was monitored.
RESULTS
The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively). Geometric mean titers for serogroups C, W, and Y were higher with MenACYW-TT than for MenACWY-CRM. Both vaccines were well-tolerated and had similar safety profiles.
CONCLUSIONS
MenACYW-TT was well-tolerated in children and achieved noninferior immune responses to MenACWY-CRM against each of the 4 vaccine serogroups.
Topics: Antibodies, Bacterial; Child; Child, Preschool; Double-Blind Method; Drugs, Investigational; Humans; Immunogenicity, Vaccine; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Puerto Rico; Tetanus Toxoid; United States; Vaccination; Vaccines, Combined; Vaccines, Conjugate
PubMed: 32852352
DOI: 10.1097/INF.0000000000002832 -
American Family Physician Nov 2005Invasive disease caused by Neisseria meningitidis has an average annual incidence of one case per 100,000 in the United States. The disease can be rapidly fatal or... (Review)
Review
Invasive disease caused by Neisseria meningitidis has an average annual incidence of one case per 100,000 in the United States. The disease can be rapidly fatal or result in severe neurologic and vascular sequelae despite antibiotic therapy. Antibiotic chemoprophylaxis with rifampin, ciprofloxacin, or ceftriaxone is required for household and other close contacts. Although the majority of cases of meningococcal disease are sporadic, outbreaks can occur, and vaccination of the affected population often is necessary. Serogroup B accounts for the highest incidence of disease in young infants but is not contained in any vaccine licensed in the United States. Adolescents and young adults 15 to 24 years of age have a higher incidence of disease and a higher fatality rate than other populations. Because 70 to 80 percent of these infections in the United States are caused by meningococcal serogroups C, Y, and W-135, which are contained in the tetravalent meningococcal vaccines, they are potentially preventable. The U.S. Food and Drug Administration recently approved a meningococcal conjugate vaccine containing serogroups A, C, Y, and W-135. This T-cell-dependent vaccine induces bactericidal antibody production and promotes immunologic memory that should result in a longer duration of immunity. The Advisory Committee on Immunization Practices recommends that this vaccine be given to 11- and 12-year-old adolescents, to adolescents entering high school, and to college freshmen living in dormitories. The vaccine also may be given to persons 11 to 55 years of age who belong to certain high-risk groups.
Topics: Adolescent; Adult; Anti-Bacterial Agents; Child; Drug Approval; Humans; Infant; Meningitis, Meningococcal; Meningococcal Vaccines; Middle Aged; Neisseria meningitidis; Risk Factors; United States; United States Food and Drug Administration
PubMed: 16342836
DOI: No ID Found -
Biotechnology Journal Sep 2015Outer membrane vesicles (OMVs) are released spontaneously during growth by many Gram-negative bacteria. They present a range of surface antigens in a native conformation... (Review)
Review
Outer membrane vesicles (OMVs) are released spontaneously during growth by many Gram-negative bacteria. They present a range of surface antigens in a native conformation and have natural properties like immunogenicity, self-adjuvation and uptake by immune cells which make them attractive for application as vaccines against pathogenic bacteria. In particular with Neisseria meningitidis, they have been investigated extensively and an OMV-containing meningococcal vaccine has recently been approved by regulatory agencies. Genetic engineering of the OMV-producing bacteria can be used to improve and expand their usefulness as vaccines. Recent work on meningitis B vaccines shows that OMVs can be modified, such as for lipopolysaccharide reactogenicity, to yield an OMV product that is safe and effective. The overexpression of crucial antigens or simultaneous expression of multiple antigenic variants as well as the expression of heterologous antigens enable expansion of their range of applications. In addition, modifications may increase the yield of OMV production and can be combined with specific production processes to obtain high amounts of well-defined, stable and uniform OMV particle vaccine products. Further improvement can facilitate the development of OMVs as platform vaccine product for multiple applications.
Topics: Animals; Bacterial Outer Membrane Proteins; Biotechnology; Humans; Lipopolysaccharides; Membranes, Artificial; Meningococcal Vaccines; Mice; Nanoparticles; Neisseria meningitidis; Vaccines
PubMed: 26912077
DOI: 10.1002/biot.201400395 -
Human Vaccines & Immunotherapeutics 2019Meningococcal serogroup B (MenB) is the predominant cause of invasive meningococcal disease in the United States, with older adolescents and young adults attending... (Review)
Review
Meningococcal serogroup B (MenB) is the predominant cause of invasive meningococcal disease in the United States, with older adolescents and young adults attending college at increased risk. Notably, MenB caused all meningococcal disease outbreaks at US colleges between 2011 and 2018. MenB disease is vaccine-preventable. The MenB-FHbp vaccine can be administered on a 2-dose (0 and 6 months) schedule to healthy adolescents and young adults or as a tailored 3-dose (0, 1-2, and 6 months) schedule for individuals at increased risk. This review focuses on the 2-dose schedule (0 and 6 months) of MenB-FHbp. Clinical evidence demonstrating strong and broadly protective immunogenicity in adolescents after primary vaccination, immune persistence up to 48 months post-primary vaccination (18-61% of subjects across schedules), and immune memory evidenced by robust response to a single booster dose are described. Implementation approaches to ensure adolescents and young adults are fully vaccinated against meningococcal disease are discussed.
Topics: Adolescent; Disease Outbreaks; Humans; Immunization Schedule; Immunization, Secondary; Immunogenicity, Vaccine; Immunologic Memory; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Physicians; Practice Guidelines as Topic; United States; Young Adult
PubMed: 30932730
DOI: 10.1080/21645515.2019.1596711 -
Vaccine Aug 2015Vaccination programs employing capsular-based meningococcal vaccines have proved successful in a variety of settings globally since first introduced over 40 years ago.... (Review)
Review
Vaccination programs employing capsular-based meningococcal vaccines have proved successful in a variety of settings globally since first introduced over 40 years ago. Similar successes have been demonstrated using meningococcal vaccines for use against serogroup B (MenB) outbreak strains but the diversity of MenB strains has limited vaccine use outside targeted geographic regions. MenB continues to be a significant cause of outbreaks in adolescents and young adults, as recently demonstrated in university settings in the US (Princeton, New Jersey and Santa Barbara, California) and has the potential for hyperendemic disease levels such as currently experienced in Québec and the United Kingdom. In adolescents, increased endemic disease rates and outbreak potential are likely associated with social behaviors putting individuals at risk for carriage acquisition and may explain regional and temporal variations in epidemiology. A protein-based, multi-component MenB vaccine (4CMenB) is currently licensed for use in 37 countries including EU/EEA countries, Australia, Canada, Chile, Colombia, Uruguay, and the US. In this article we review the most recent clinical trial data with 4CMenB with a focus on adolescents and young adults. The vaccine appears to have an acceptable safety profile and is well-tolerated in adolescents and young adults while providing robust, persistent levels of bactericidal antibodies considered protective for each of the four antigenic components of the vaccine. With the recent availability of this vaccine, health care providers have the first comprehensive opportunity to control meningococcal disease, a highly disruptive public health problem with a disproportionate impact on adolescents and young adults.
Topics: Adolescent; Antibodies, Bacterial; Blood Bactericidal Activity; Global Health; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Young Adult
PubMed: 26187261
DOI: 10.1016/j.vaccine.2015.06.011 -
BMC Public Health Mar 2023Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria...
An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol.
BACKGROUND
Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria gonorrhoeae infections each year, with several populations at higher risk for gonococcal infection, including gay and bisexual men (GBM). If left untreated, infection can lead to serious morbidity including infertility, sepsis and increased risk of HIV acquisition. Development of a gonorrhoea vaccine has been challenging, however there is observational evidence that serogroup B meningococcal vaccines, used to protect against the closely related bacteria Neisseria meningitidis, could provide cross-protection against N. gonorrhoeae.
METHODS
The MenGO (Meningococcal vaccine efficacy against Gonorrhoea) study is a phase III open-label randomised control trial in GBM to evaluate the efficacy of the four-component meningococcal serogroup B vaccine, 4CMenB, against gonorrhoea. A total of 130 GBM will be recruited at the Gold Coast Sexual Health Clinic, Australia, and randomised to either receive 2 doses of 4CMenB or no intervention. Participants will be followed up for 24 months with testing for N. gonorrhoeae and other sexually transmissible infections every three months. Demographics, sexual behaviour risk, antibiotic use, and blood samples for analysis of N. gonorrhoeae-specific immune responses, will be collected during the study. The primary outcome is the number of N. gonorrhoeae infections in participants over 2 years measured by nucleic acid amplification test (NAAT). Secondary outcomes are vaccine-induced N. gonorrhoeae-specific immune responses, and adverse events in trial participants.
DISCUSSION
This trial will determine if the 4CMenB vaccine is able to reduce N. gonorrhoeae infection. If shown to be effective, 4CMenB could be used in gonococcal prevention. Analysis of 4CMenB-induced immune responses will increase understanding of the type of immune response needed to prevent N. gonorrhoeae, which may enable identification of a potential correlate of protection to aid future gonorrhoea vaccine development.
TRIAL REGISTRATION
The trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.
Topics: Humans; Male; Australia; Clinical Trials, Phase III as Topic; Gonorrhea; Meningococcal Infections; Meningococcal Vaccines; Neisseria gonorrhoeae; Neisseria meningitidis, Serogroup B; Randomized Controlled Trials as Topic; Serogroup; Sexual and Gender Minorities; Sexual Behavior
PubMed: 36997957
DOI: 10.1186/s12889-023-15516-y -
Tropical Medicine & International... Mar 2022To evaluate the impact of meningococcal C conjugate (MCC) vaccine in Brazil.
OBJECTIVE
To evaluate the impact of meningococcal C conjugate (MCC) vaccine in Brazil.
METHODS
Ecological study assessing all invasive meningococcal disease (IMD) and meningococcal C disease (MenC) cases reported in all age groups, from 2001 to 2019. MCC was implemented in 2010. Data were collected on the DATASUS platform. Joinpoint regression was performed to assess the annual percent change (APC) of the incidence rate.
RESULTS
Invasive meningococcal disease incidence decreased in all Brazilian regions from 2001 onwards, without apparent additional reduction attributable to MCC vaccine in the North, Northeast and South. The higher and statistically significant APC reduction in all age groups, in the North and South, and in children <5 years, in the Northeast, occurred between 2001 and 2011 (-15.4%), 2004 and 2012 (-14.4%), and 2001 and 2013 (-10.3%), respectively, before MCC vaccine implementation. Annual incidence of MenC in children under 5 years significantly fell in the North (-6.8%; 2011-2018), Southeast (-40.6%; 2010-2015) and Midwest (-48.6%; 2010-2014), which may be attributable to MCC implementation.
CONCLUSION
Invasive meningococcal disease and MenC behaved differently after MCC vaccine implementation in Brazil during this 18-year time-series analysis. This suggests that the control of IMD should be based on multiple public health care measures and considered on a regional basis.
Topics: Brazil; Child; Child, Preschool; Humans; Incidence; Infant; Meningococcal Infections; Meningococcal Vaccines; Time Factors; Vaccines, Conjugate
PubMed: 34997999
DOI: 10.1111/tmi.13718 -
Clinical Infectious Diseases : An... Nov 2015A group A meningococcal conjugate vaccine (PsA-TT) was developed specifically for the African "meningitis belt" and was prequalified by the World Health Organization... (Review)
Review
BACKGROUND
A group A meningococcal conjugate vaccine (PsA-TT) was developed specifically for the African "meningitis belt" and was prequalified by the World Health Organization (WHO) in June 2010. The vaccine was first used widely in Burkina Faso, Mali, and Niger in December 2010 with great success. The remaining 23 meningitis belt countries wished to use this new vaccine.
METHODS
With the help of African countries, WHO developed a prioritization scheme and used or adapted existing immunization guidelines to mount PsA-TT vaccination campaigns. Vaccine requirements were harmonized with the Serum Institute of India, Ltd.
RESULTS
Burkina Faso was the first country to fully immunize its 1- to 29-year-old population in December 2010. Over the next 4 years, vaccine coverage was extended to 217 million Africans living in 15 meningitis belt countries.
CONCLUSIONS
The new group A meningococcal conjugate vaccine was well received, with country coverage rates ranging from 85% to 95%. The rollout proceeded smoothly because countries at highest risk were immunized first while attention was paid to geographic contiguity to maximize herd protection. Community participation was exemplary.
Topics: Africa South of the Sahara; Disease Transmission, Infectious; Humans; Immunization Programs; Meningitis, Meningococcal; Meningococcal Vaccines; Vaccination; Vaccines, Conjugate
PubMed: 26553672
DOI: 10.1093/cid/civ551 -
Clinical Microbiology Reviews Jan 2006Neisseria 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... (Review)
Review
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.
Topics: Adolescent; Adult; Child; Child, Preschool; Drug Design; Humans; Meningococcal Infections; Meningococcal Vaccines; Middle Aged; Neisseria meningitidis; Serotyping; Vaccination; Vaccines, Conjugate
PubMed: 16418528
DOI: 10.1128/CMR.19.1.142-164.2006