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

Jamie Findlow; Xilian Bai; Helen Findlow; Emma Newton; Edward Kaczmarski; Elizbeth Miller; Raymond Borrow

doi:10.1016/j.vaccine.2015.05.027

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

Jamie Findlow^*, Xilian Bai, Helen Findlow, Emma Newton, Edward Kaczmarski, Elizbeth Miller, Raymond Borrow

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

35 Citations (Scopus)

Abstract

Safety precautions for laboratory staff working with meningococci should primarily rely on laboratory procedures preventing exposure to aerosols containing viable meningococci. Despite this, vaccination is a key component of protection in the occupational setting. In the UK in 2009, there were no licensed vaccines for meningococcal capsular group B or conjugate vaccines for capsular groups A, C, W and Y. We therefore undertook a Phase II trial in laboratory workers to investigate the safety and immunogenicity of a four component group B vaccine (4CMenB) and a quadrivalent group A, C, W and Y conjugate vaccine (ACWY-CRM).Enrolment was open to staff aged 18-65 years at the Public Health Laboratory, Manchester who may have had a potential occupational exposure risk to meningococci. 4CMenB was administered at 0, 2 and 6 months in the non-dominant arm and ACWY-CRM concomitantly at 0 months in the dominant arm. Pre- and post-vaccination blood samples were taken and analysed by the serum bactericidal antibody (SBA) assay against A, C, W and Y strains and a panel of seven diverse group B strains. Diary cards were used to record any local and systemic reactions following each vaccination.In total, 38 staff were enrolled and received initial vaccinations with 31 completing the trial per protocol. Both vaccines were proven safe, with local reactogenicity being more commonly reported following 4CMenB than ACWY-CRM. High proportions of subjects had putative protective SBA titres pre-vaccination, with 61-84 and 61-87% protected against A, C, W and Y strains and diverse MenB strains, respectively. Post-vaccination, SBA titres increased with 95-100 and 90-100% of subjects with protective SBA titres against A, C, W and Y strains and diverse MenB strains, respectively.These data suggest that 4CMenB and ACWY-CRM are safe when administered concomitantly and have the potential to enhance protection for laboratory workers.www.clinicaltrials.gov identifier: NCT00962624.

Original language	English
Pages (from-to)	3322-3330
Number of pages	9
Journal	Vaccine
Volume	33
Issue number	29
DOIs	https://doi.org/10.1016/j.vaccine.2015.05.027
Publication status	Published - 26 Jun 2015

Bibliographical note

Funding Information:
The trial was funded by the Meningitis Research Foundation, sponsored by PHE (formally the Health Protection Agency) and was conducted in accordance with the 1996 International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines, the 2000 Declaration of Helsinki and the 2004 EU Clinical Trial Directive. A favourable opinion was given by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Research Ethics Service, Wandsworth Research Ethics Committee. The EudraCT number was 2008-007182-23 and the trial was registered on the public website www.clinicaltrials.gov under the identifier: NCT00962624.

Keywords

4CMenB
ACWY-CRM
Laboratory workers
Meningococcal
Vaccine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.vaccine.2015.05.027

Cite this

Findlow, J., Bai, X., Findlow, H., Newton, E., Kaczmarski, E., Miller, E., & Borrow, R. (2015). 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. Vaccine, 33(29), 3322-3330. https://doi.org/10.1016/j.vaccine.2015.05.027

@article{4c84bc1e15fe478b8593473c530c8445,

title = "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",

abstract = "Safety precautions for laboratory staff working with meningococci should primarily rely on laboratory procedures preventing exposure to aerosols containing viable meningococci. Despite this, vaccination is a key component of protection in the occupational setting. In the UK in 2009, there were no licensed vaccines for meningococcal capsular group B or conjugate vaccines for capsular groups A, C, W and Y. We therefore undertook a Phase II trial in laboratory workers to investigate the safety and immunogenicity of a four component group B vaccine (4CMenB) and a quadrivalent group A, C, W and Y conjugate vaccine (ACWY-CRM).Enrolment was open to staff aged 18-65 years at the Public Health Laboratory, Manchester who may have had a potential occupational exposure risk to meningococci. 4CMenB was administered at 0, 2 and 6 months in the non-dominant arm and ACWY-CRM concomitantly at 0 months in the dominant arm. Pre- and post-vaccination blood samples were taken and analysed by the serum bactericidal antibody (SBA) assay against A, C, W and Y strains and a panel of seven diverse group B strains. Diary cards were used to record any local and systemic reactions following each vaccination.In total, 38 staff were enrolled and received initial vaccinations with 31 completing the trial per protocol. Both vaccines were proven safe, with local reactogenicity being more commonly reported following 4CMenB than ACWY-CRM. High proportions of subjects had putative protective SBA titres pre-vaccination, with 61-84 and 61-87% protected against A, C, W and Y strains and diverse MenB strains, respectively. Post-vaccination, SBA titres increased with 95-100 and 90-100% of subjects with protective SBA titres against A, C, W and Y strains and diverse MenB strains, respectively.These data suggest that 4CMenB and ACWY-CRM are safe when administered concomitantly and have the potential to enhance protection for laboratory workers.www.clinicaltrials.gov identifier: NCT00962624.",

keywords = "4CMenB, ACWY-CRM, Laboratory workers, Meningococcal, Vaccine",

author = "Jamie Findlow and Xilian Bai and Helen Findlow and Emma Newton and Edward Kaczmarski and Elizbeth Miller and Raymond Borrow",

note = "Funding Information: The trial was funded by the Meningitis Research Foundation, sponsored by PHE (formally the Health Protection Agency) and was conducted in accordance with the 1996 International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines, the 2000 Declaration of Helsinki and the 2004 EU Clinical Trial Directive. A favourable opinion was given by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Research Ethics Service, Wandsworth Research Ethics Committee. The EudraCT number was 2008-007182-23 and the trial was registered on the public website www.clinicaltrials.gov under the identifier: NCT00962624. ",

year = "2015",

month = jun,

day = "26",

doi = "10.1016/j.vaccine.2015.05.027",

language = "English",

volume = "33",

pages = "3322--3330",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier",

number = "29",

}

Findlow, J, Bai, X, Findlow, H, Newton, E, Kaczmarski, E, Miller, E & Borrow, R 2015, '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', Vaccine, vol. 33, no. 29, pp. 3322-3330. https://doi.org/10.1016/j.vaccine.2015.05.027

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 et al.
In: Vaccine, Vol. 33, No. 29, 26.06.2015, p. 3322-3330.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Findlow, Jamie

AU - Bai, Xilian

AU - Findlow, Helen

AU - Newton, Emma

AU - Kaczmarski, Edward

AU - Miller, Elizbeth

AU - Borrow, Raymond

N1 - Funding Information: The trial was funded by the Meningitis Research Foundation, sponsored by PHE (formally the Health Protection Agency) and was conducted in accordance with the 1996 International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines, the 2000 Declaration of Helsinki and the 2004 EU Clinical Trial Directive. A favourable opinion was given by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Research Ethics Service, Wandsworth Research Ethics Committee. The EudraCT number was 2008-007182-23 and the trial was registered on the public website www.clinicaltrials.gov under the identifier: NCT00962624.

PY - 2015/6/26

Y1 - 2015/6/26

N2 - Safety precautions for laboratory staff working with meningococci should primarily rely on laboratory procedures preventing exposure to aerosols containing viable meningococci. Despite this, vaccination is a key component of protection in the occupational setting. In the UK in 2009, there were no licensed vaccines for meningococcal capsular group B or conjugate vaccines for capsular groups A, C, W and Y. We therefore undertook a Phase II trial in laboratory workers to investigate the safety and immunogenicity of a four component group B vaccine (4CMenB) and a quadrivalent group A, C, W and Y conjugate vaccine (ACWY-CRM).Enrolment was open to staff aged 18-65 years at the Public Health Laboratory, Manchester who may have had a potential occupational exposure risk to meningococci. 4CMenB was administered at 0, 2 and 6 months in the non-dominant arm and ACWY-CRM concomitantly at 0 months in the dominant arm. Pre- and post-vaccination blood samples were taken and analysed by the serum bactericidal antibody (SBA) assay against A, C, W and Y strains and a panel of seven diverse group B strains. Diary cards were used to record any local and systemic reactions following each vaccination.In total, 38 staff were enrolled and received initial vaccinations with 31 completing the trial per protocol. Both vaccines were proven safe, with local reactogenicity being more commonly reported following 4CMenB than ACWY-CRM. High proportions of subjects had putative protective SBA titres pre-vaccination, with 61-84 and 61-87% protected against A, C, W and Y strains and diverse MenB strains, respectively. Post-vaccination, SBA titres increased with 95-100 and 90-100% of subjects with protective SBA titres against A, C, W and Y strains and diverse MenB strains, respectively.These data suggest that 4CMenB and ACWY-CRM are safe when administered concomitantly and have the potential to enhance protection for laboratory workers.www.clinicaltrials.gov identifier: NCT00962624.

AB - Safety precautions for laboratory staff working with meningococci should primarily rely on laboratory procedures preventing exposure to aerosols containing viable meningococci. Despite this, vaccination is a key component of protection in the occupational setting. In the UK in 2009, there were no licensed vaccines for meningococcal capsular group B or conjugate vaccines for capsular groups A, C, W and Y. We therefore undertook a Phase II trial in laboratory workers to investigate the safety and immunogenicity of a four component group B vaccine (4CMenB) and a quadrivalent group A, C, W and Y conjugate vaccine (ACWY-CRM).Enrolment was open to staff aged 18-65 years at the Public Health Laboratory, Manchester who may have had a potential occupational exposure risk to meningococci. 4CMenB was administered at 0, 2 and 6 months in the non-dominant arm and ACWY-CRM concomitantly at 0 months in the dominant arm. Pre- and post-vaccination blood samples were taken and analysed by the serum bactericidal antibody (SBA) assay against A, C, W and Y strains and a panel of seven diverse group B strains. Diary cards were used to record any local and systemic reactions following each vaccination.In total, 38 staff were enrolled and received initial vaccinations with 31 completing the trial per protocol. Both vaccines were proven safe, with local reactogenicity being more commonly reported following 4CMenB than ACWY-CRM. High proportions of subjects had putative protective SBA titres pre-vaccination, with 61-84 and 61-87% protected against A, C, W and Y strains and diverse MenB strains, respectively. Post-vaccination, SBA titres increased with 95-100 and 90-100% of subjects with protective SBA titres against A, C, W and Y strains and diverse MenB strains, respectively.These data suggest that 4CMenB and ACWY-CRM are safe when administered concomitantly and have the potential to enhance protection for laboratory workers.www.clinicaltrials.gov identifier: NCT00962624.

KW - 4CMenB

KW - ACWY-CRM

KW - Laboratory workers

KW - Meningococcal

KW - Vaccine

UR - http://www.scopus.com/inward/record.url?scp=84931562744&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2015.05.027

DO - 10.1016/j.vaccine.2015.05.027

M3 - Article

C2 - 26025807

AN - SCOPUS:84931562744

SN - 0264-410X

VL - 33

SP - 3322

EP - 3330

JO - Vaccine

JF - Vaccine

IS - 29

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this