Fast Track Licensing of Meningococcal B OMV Vaccine MeNZB

1
Fast TrackLicensing of Meningococcal B OMV
Vaccine MeNZB

• Jane OHallahan

2
An Epidemic or Not?
Number of Cases
Pre-epidemic Number
Years
3
An Epidemic Unfolds
6 point plan
Number of Cases
Pre-epidemic Number
Years
4
A Search in Earnest
WHO Meeting
Number of Cases
Pre-epidemic Number
Years
Years
5
Fast Track for MeNZB
Chiron Selected
Number of Cases
Pre-epidemic Number
Years
Years
6
Fast Track (2001-2004)

• Usually 8 14 years
• Taken 2 years from first trial
• Vaccine development
• Vaccine trials
• Producing regulatory file
• Applying for licensure
• Roll out

7
A Unique Partnership
Number of Cases
Years
8
Licensure of a New OMV Vaccine in NZ is Dependent
on
9

• An immunogenic tailor-made vaccine
• Reactogenicity and safety profile
• Physiochemical bridging to parent
• A validated assay
• licence to roll out high risk
• Intensive safety monitoring and effectiveness
  assessment
• Extension of delivery to all
• under 20s

Licence
10
1.Development of an immunogenic tailor-made
vaccine to the specific NZ sero subtype
11
The Vaccine - MeNZB

• Designer Label
• Exclusive
• 3 doses 6 weeks apart
• Intramuscular

12
Clinical Trials

• Phase I
• 75 Adults FINISHED
• Started May 2002
• Phase II
• 600 School Children FINISHED
• Started October 2002
• 300 Toddlers FINISHED
• Started February 2003
• 300 Late Infants FINISHED
• Started May 2003
• 300 Early Infants ONGOING
• Started January 2004

Number of Cases
Years
13
2. An acceptable safety and reactogenicity
profile
14
Is MeNZB Safe?

• Tested on 1700 children
• No serious adverse reactions

15
Adverse Reactions in Clinical Trials

• Frequent mild to moderate injection site
  reactions
• May last 2-3 days
• Reaction to one dose doesnt mean same reaction
  to next
• Severe reactions uncommon
• Systemic reactions occur

16
3.Can be physicochemically bridged to the parent
vaccine
17

• MenBVac

MeNZB
18
MenBVac

• Strain B15P1.7,16
• Two doses at 6-8 weeks interval
• Efficacy _at_ 29 months 57
• _at_ 10 months efficacy 86

Number of Cases
Years
19
MenBVac Adverse Events

• Local and systemic adverse events low
• 4 cases of serious neurological disease reported
  in efficacy studies
• Large epidemiological study showed no increased
  risk of neurological events

20
4.Development and standardisation of an assay
21
Measurement of Immune Response

• Serum bactericidal assay (SBA) used
• Efficacy to be determined during roll out

22
Example of Serum Bacterial Antibody Response to
MeNZB Vaccine
8.0
7.0
NZ98/254
6.0
5.0
Number of Cases
Log2 Interpolated Titre
4.0
3.0
Key Visit 1 - pre-vaccination Visit 2 -
post-vaccination dose 1 Visit 3 -
post-vaccination dose 2 Visit 4 -
post-vaccination dose 3
2.0
1.0
0.0
1
2
3
4
Visit
Years
23
5.An application for licence to roll out in the
highest risk area
24
Meningococcal Disease Rates per 100,000 by
District Health Board 2003
Auckland
25
6.Intensive real time safety monitoring and
vaccine failure monitoring
26
Adverse Reaction Surveillance

• Usual method passive reporting
• Additional surveillance
• - Hospital-based active surveillance
• - Linkage of hospital discharge
• - General practice active
• surveillance

27
Immunisation Safety Surveillance

• Identify events caused by vaccination
• Enable causality assessment
• Increase public confidence
• Independent Safety
• Monitoring Board

28
7.Extension of delivery to all under 20s with
careful disease surveillance and assessment of
vaccine effectiveness
29
In Summary
30
In Summary Key Points

• An immunogenic tailor-made vaccine
• Reactogenicity and safety profile
• Physiochemical bridging to parent
• A validated assay
• Licence to roll out high risk
• Intensive safety monitoring and
• effectiveness assessment
• 7. Extension of delivery to all under 20s

Licence
31
Presentation Acknowledgements

• Meningococcal Management Team
• Jane OHallahan (Ministry of Health)
• Diana Lennon (University of Auckland)
• Philipp Oster (Chiron Vaccines)
• Advisors to MMT
• Kim Mulholland (University of Melbourne)
• Diana Martin (ESR)
• Stewart Reid (GP)
• Joanna Stewart (University of Auckland)
• Teuila Percival (Kidz First Hospital)
• Liane Penney (Massey University)