[CIS PIDD] [cis-pidd] Meningococcal B Vaccination in Complement Deficiency

Sun Apr 16 13:08:10 EDT 2017

Hello everyone,

I agree with all the comments made so far.  We have pushed to use bexsero in all of our younger aplenic and complement deficiency patients based on the new zealand data.  It has been a little work to get preauthorization for some kids, but usually we have been successful.

This would be a good topic that CIS should probably weigh in on with future pratice statements.  The AAP and CDC statements are a wonderful start, but often dont't have our patient population in mind when they are written.

Best,
Mike

Michael D. Keller, MD
Assistant Professor, Division of Allergy / Immunology
Center for Cancer and Immunology Research
Jeffrey Modell Diagnostic and Research Center for
Primary Immunodeficiency Disorders
Children's National Health System
111 Michigan Ave NW<x-apple-data-detectors://1>, M7745A
Washington, DC 20010<x-apple-data-detectors://2>
Clinic: 202.476.2140<tel:202.476.2140>
Office: 202.476.5843<tel:202.476.5843>
Fax: 202.476.2280<tel:202.476.2280>
www.ChildrensNational.org<http://www.childrensnational.org/>

On Apr 16, 2017, at 11:57 AM, CIS-PIDD <cis-pidd at lists.clinimmsoc.org<mailto:cis-pidd at lists.clinimmsoc.org>> wrote:

In red text following is the response from Dr. Manish Sandarangani (msandarangani at bcchr.ubc.ca<mailto:msandarangani at bcchr.ubc.ca>) the head of our Vaccine Evaluation Center, Vancouver, British Columbia

Anne Junker, MD; Associate Professor, Pediatrics (Clinical Immunology): BC Children's Hospital and University of British Columbia

Sent: Friday, April 14, 2017 5:13 PM

To: CIS-PIDD

Dear All,

I follow two sisters with a C2 deficiency - ages 5 and 7 years.  I would like advice regarding:

1) In the USA, the meningococcal B vaccines are licensed for 10 years and above.  I would like to vaccinate them now and wanted to know if there is any consensus for vaccinating at this younger age?

Bexsero is not licensed or approved <10 years in the US for any indication (don’t really know why). In Canada and in the UK, Bexsero IS recommended in this situation (2 doses, at least 2 months apart). A study in this population has been done in Europe – results have been posted on Clinicaltrials.gov<http://Clinicaltrials.gov> (https://www.clinicaltrials.gov/ct2/results?term=NCT02141516&Search=Search<https://urldefense.proofpoint.com/v2/url?u=https-3A__www.clinicaltrials.gov_ct2_results-3Fterm-3DNCT02141516-26Search-3DSearch&d=DwMF-g&c=Zoipt4Nmcnjorr_6TBHi1A&r=mERX_I8PKb0Uil9coedoT1CtvFqkSey45L0vbcX0oKI&m=a2ykFCznUmTCIrtjP_V6uEd83wiR0Np7DS9LDqDaKkc&s=8oWNXrymvenwzl-2K6OYePVRALbnEXWBeV4ZLFDePAo&e=>) but not yet published as far as I can find. Interestingly, published case reports/case series suggest that children with complement deficiency rarely get infected with MenB, but usually other serogroups and particularly less common serogroups, although no one really knows why – I would still vaccinate, but it is an interesting observation.

2) We have two vaccine available in the US - Bexsero and Trumenba.  It seems like there is more worldwide experience using the Bexesero in younger children, but I wanted to know if one vaccine is preferred over the other for < 10 years old, or in patients with complement deficiencies?

Trumenba is not licensed in any jurisdiction in younger children – the early phase I/II studies had very high rates of adverse events in this age group, so later trials were focussed on adolescents and adults only. So Bexsero is really the only option in this age.

3) The dose for each vaccine in >10 year olds is 0.5 mL.  Is a lower dose used for <10 year olds, especially the 5 year old sister?

Use standard dose of 0.5 ml in all ages groups – this is the dose used in the UK, where Bexsero is included in the routine childhood immunization program from 2 months of age.

The only final point I would add is that no one knows how frequently booster doses should be given in this age for those children at ongoing increased risk. Studies are ongoing. I have just had a paper accepted showing significant waning of immunity by 4 years of age in children immunized at 12-24 months, but a good response to the booster (should be published in CMAJ very soon). Also I don’t know where things stand in the US if you want to give vaccines out of the licensed age group, but I presume Ron would know that.

Ron

Ronald M. Ferdman, MD, MEd

Children's Hospital Los Angeles

Division of Clinical Immunology and Allergy Associate Professor of Clinical Pediatrics Keck School of Medicine University of Southern California

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