Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers

Findlow, Jamie; Bai, Xilian; Findlow, Helen; Newton, Emma; Kaczmarski, E.B.; Miller, Elizabeth; Borrow, Ray

doi:10.1016/j.vaccine.2015.05.027

Cited by 36 publications

(39 citation statements)

References 38 publications

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“…Nine concomitant meningococcal vaccine studies performed in adults (individuals >25 years of age) are summarized in Table 2. 52,68,[76][77][78][79][80][81][82] All of these studies also included individuals ≤25 years of age; however, results were not reported by age subgroup, and all adult studies lacked the focus on adolescents and/or young adults that characterized the studies described previously. As for the adolescent and young adult studies, safety findings from adult studies were generally unremarkable; 68,[76][77][78][79][80][81][82] exceptions are noted in the following sections where applicable.…”

Section: Adult Studies On Concomitant Administrationmentioning

confidence: 99%

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

Alderfer

Srivastava

Istúriz

et al. 2019

Human Vaccines & Immunotherapeutics

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Invasive meningococcal disease (IMD), a rapidly progressing and potentially fatal illness, disproportionately affects adolescents and young adults. While IMD is best prevented by vaccination, vaccine uptake in these groups is low. An evidence-based understanding of the safety and effectiveness of concomitant vaccination of meningococcal vaccines, including the newer MenB protein vaccines and the more established MenACWY conjugate vaccines, with other vaccines recommended for adolescents and young adults may help maximize vaccination opportunities. We identified 21 studies assessing concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults. Although studies varied in methodology, concomitant administration generally did not affect immunogenicity of the meningococcal or coadministered vaccines. In some cases, reactogenicity increased following concomitant administration, but no definitive safety concerns were raised. In general, data suggest that meningococcal vaccines can be safely and effectively coadministered with other vaccines.

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Section: Adult Studies On Concomitant Administrationmentioning

confidence: 99%

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

Alderfer

Srivastava

Istúriz

et al. 2019

Human Vaccines & Immunotherapeutics

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“…4CMenB is approved for use in 37 countries including EU/EEA countries, Australia, Canada, Chile, Colombia, and Uruguay and is recently approved in the US. A total of 9 studies (5 randomized controlled, 3 open-label single-arm, 1 post-licensure) which enrolled adolescents and adults to receive 4CMenB have been conducted (see Table 1) [37][38][39][40][41][42][43][44][45]. A total of 63,368 adolescents and young adults received 4CMenB vaccination in studies conducted in the US, Canada, Chile, UK, Germany, Switzerland, Italy and Australia.…”

Section: Use Of a Multicomponent Menb Vaccine In Adolescents And Younmentioning

confidence: 99%

“…In total, six studies included immunogenicity objectives of which the results of four have been published (Table 1) [37][38][39][40]43,44]. The four published studies supported a two-dose vaccine schedule in adolescents and adults [37][38][39][40].…”

Section: Immunogenicitymentioning

confidence: 99%

Vaccination with a multicomponent meningococcal B vaccine in prevention of disease in adolescents and young adults

Nolan

O’Ryan

Wassil

et al. 2015

Vaccine

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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.

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“…A booster vaccination is additionally required for children vaccinated in the first 2 years of life (see the Summary of Product Characteristics for information on the approved vaccination schedules). Study results on co-administration with Infanrix hexa Ò , Prevenar 7 Ò , MMRV in infants and toddlers and with Menveo Ò in adults for the most part showed no impairment of immunogenicity [35][36][37][38]. Bexsero Ò can be administered simultaneously with the following vaccine antigens (as monovalent or in combination vaccines): diphtheria, tetanus, pertussis, Haemophilus in fluenzae type b, poliomyelitis (inactivated vaccine), hepatitis B, heptavalent pneumococci conjugate, measles, mumps, rubella, varicella.…”

Section: The Vaccinementioning

confidence: 96%

Background Paper for the update of meningococcal vaccination recommendations in Germany: use of the serogroup B vaccine in persons at increased risk for meningococcal disease

Hellenbrand

Koch

Harder

et al. 2015

Bundesgesundheitsbl.

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Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers

Cited by 36 publications

References 38 publications

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence

Vaccination with a multicomponent meningococcal B vaccine in prevention of disease in adolescents and young adults

Background Paper for the update of meningococcal vaccination recommendations in Germany: use of the serogroup B vaccine in persons at increased risk for meningococcal disease

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