South Australian Meningococcal B Vaccine Herd Immunity Study

Meningococcal Disease Clinical Trial

— B Part of It  

Official title:

South Australian Meningococcal B Vaccine Herd Immunity Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089086
• Other study ID #: HREC/16/WCHN/140
• Secondary ID: ACTRN12617000079
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.

Description:

This cluster randomised controlled study will be conducted in the context of funded 4CMenB vaccine offered to all students in years 10, 11, and 12.

Year 10 and 11 students will undergo baseline and 12 months posterior pharyngeal swabs. Year 12 students will undergo baseline posterior pharyngeal swabs only.

Randomisation will take place at the school level and will be stratified by school size ((<60, 60 to 119, and ≥120 students per year level) and school socio-economic status (SES), as measured by the Index of Community Socio-Educational Advantage (ICSEA); (ICSEA <970, 970 to 1020, >1020) For the purposes of the study a school is defined as an educational institution at which students in years 10, 11, 12 physically attend school during the week. All 260 schools in metropolitan and rural SA will be approached to participate in the study. All schools agreeing to participate will be randomised to 4CMenB vaccine in 2017 or 2018. Students at schools randomised to receive the vaccine at baseline will receive the 4CMenB vaccine in 2017. Students at schools randomised to receive the vaccine at the 12 month posterior pharyngeal swab will receive the 4CMenB vaccine in 2018.

Primary Objectives

• Estimate the difference in carriage prevalence of disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.

Secondary objectives

• Estimate the difference in carriage prevalence of each disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.

• Estimate the difference in carriage prevalence of all genogroups of N. meningitidis following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero ®, compared to unvaccinated students.

• Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students.

• Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of all genogroups of N. meningitidis over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students

• Identify characteristics associated with carriage prevalence of all genogroups N. meningitidis in South Australian school students at baseline and 12 months.

• Identify characteristics associated with carriage prevalence of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) in South Australian school students at baseline and 12 months.

Exploratory objectives

• Describe changes in invasive meningococcal rates (attack rates) across all age groups pre and post 4CMenB vaccine intervention in South Australia.

• Describe N. meningitidis carriage density in year 10, 11, and 12 students using qPCR at baseline and 12 months in both vaccinated and unvaccinated students.

• Describe genome sequencing of N. meningitidis disease causing (A, B, C, W, X, Y) sequence types in year 10, 11, and 12 students at baseline and at 12 months.

• In schools randomized to Group A, describe the association of carriage prevalence of disease causing genogroups and vaccine uptake at school level following implementation.

• In schools randomized to Group A, describe the association of carriage prevalence of all N. meningitidis and vaccine uptake at school level following implementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34489
• Est. completion date: December 31, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion criteria:

• South Australian secondary school students in years 10, 11, and 12 in 2017

• Written parental consent for those under the age of 18

• Written student consent assent for those under the age of 18 (or if 18 years old and older consent for themselves)

• Available at school for at least the first pharyngeal swab and willing to comply with study procedures

Exclusion Criteria:

1. Previous anaphylaxis following any component of Bexsero vaccine

2. Previous receipt of meningococcal B vaccine (Bexsero)

3. Known pregnancy

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Licensed 4CMenB vaccine
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents.

Locations

Country	Name	City	State
Australia	Vaccinology & Immunology Research Trials Unit	North Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
University of Adelaide	SA Health

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan JM, Maiden MCJ, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler CM, Whelan J, Vadivelu K. B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents. BMJ Open. 2018 Jul 10;8(7):e020988. doi: 10.1136/bmjopen-2017-020988. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age specific IMD attack rates	Age specific IMD attack rates (per 100,000 population) in all age groups in South Australia	Prior to and following implementation of the intervention
Other	Carriage density of N. meningitidis (all genogroups)	as measured by qPCR in year 10, 11 and 12 school students at baseline and 12 months	Baseline and 12 months
Other	Description of whole genome sequences of carriage isolates	Description of whole genome sequences of isolates known to cause disease (serogroup B, W, Y, C)	Baseline and 12 months
Other	Whole genogroup sequencing of all carriage isolates	Description of whole genome sequences of isolates	Baseline and 12 months
Other	Vaccine uptake and carriage prevalence of all N. meningitidis.	Carriage prevalence as measured by PCR	12 months
Other	Vaccine uptake and carriage prevalence of disease causing N. meningitidis.	Carriage prevalence as measured by PCR	12 months
Primary	Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)	As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students	12 months
Secondary	Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)	As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students	12 months
Secondary	Prevalence of all N. meningitidis genogroups	As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students	12 months
Secondary	Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)	As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students	12 months
Secondary	Acquisition of all N. meningitidis	As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students	12 months
Secondary	Risk factors associated with carriage prevalence of all N. meningitidis	As measured by PCR at baseline and 12 months	Baseline and 12 months
Secondary	Risk factors associated with carriage prevalence of disease causing N. meningitidis	As measured by PCR at baseline and 12 months	Baseline and 12 months