HPV Immunisation update

1. Update on the programme

2. Overview of Surveillance strategy

3. Details of proposed surveillance linked to the cervical screening programme

HPV immunisation

• 3 dose immunisation given at school to girls in secondary S2 (aged 12-13)

• Catch-up immunisation for girls up to the age of 17 (including school leavers)

• Protects against 2 HR types of HPV that cause ~70% of cervical cancer

DATA MANAGEMENT

GROUP

Lead: Dr David Cromie

CORE IMPLEMENTATION GROUPHPS Project Team / Sub-Group Leads / Scottish Government / Education Authorities / SGPC

NATIONAL STEERING GROUPScottish Government (CMO, Policy, Pharmacy, Education, Primary, Comms) / Health Protection

Scotland / NHS Boards (immunisation coordinators – N,E,W / Health Scotland / SGPC / Pharmacy / Virology / NSS ISD / Education Authorities / CHPs / School Health Services…..

PROGRAMME CO-ORDINATION

14 x NHS HEALTH BOARDS (local implementation groups)UK LIAISON

SERVICE DELIVERY GROUP

(incl PHARMACY &PROCUREMENT)

Lead: Dr Lesley Wilkie

PUBLIC &PROFESSIONAL

COMMUNICATIONS & EDUCATIONLead: Ms Julia Mackay

EPIDEMIOLOGY &SURVEILLANCE

GROUP

Lead: Dr Martin Donaghy

Human Papillomavirus (HPV) Immunisation Programme

Governance

CHSP-S schedule (0, 1-2, 6)

Vaccine (Cervarix: types 16 & 18) Consent Latex School vs GP delivery"Hard to Reach"

Training materials + Professional Packs Advertising campaign Leaflets, Q&A, website

Local Implementation Plans

Data management

Service Delivery

Communications and Education

DATA MANAGEMENT

GROUP

Lead: Dr David Cromie

CORE IMPLEMENTATION GROUPHPS Project Team / Sub-Group Leads / Scottish Government / Education Authorities / SGPC

NATIONAL STEERING GROUPScottish Government (CMO, Policy, Pharmacy, Education, Primary, Comms) / Health Protection

Scotland / NHS Boards (immunisation coordinators – N,E,W / Health Scotland / SGPC / Pharmacy / Virology / NSS ISD / Education Authorities / CHPs / School Health Services…..

PROGRAMME CO-ORDINATION

14 x NHS HEALTH BOARDS (local implementation groups)UK LIAISON

SERVICE DELIVERY GROUP

(incl PHARMACY &PROCUREMENT)

Lead: Dr Lesley Wilkie

PUBLIC &PROFESSIONAL

COMMUNICATIONS & EDUCATIONLead: Ms Julia Mackay

EPIDEMIOLOGY &SURVEILLANCE

GROUP

Lead: Dr Martin Donaghy

Human Papillomavirus (HPV) Immunisation Programme

Governance

Aims for public health surveillance of the HPV programme in Scotland

• Evaluate the effect of the immunisation programme on HPV and HPV-related disease

• Inform decision making on the future optimum mix of immunisation, screening and HPV testing to reduce cervical cancer in Scotland.

• Monitor vaccine failure and adverse events that may be linked to immunisation

Core elements

1. Vaccine uptake

2. Adverse events that may be associated with immunisation

3. Knowledge attitudes and awareness in the vaccination era

4. The impact of the immunisation programme on

HPV infection in the population

5. The impact of the immunisation programme on Cervical Cancer & Precursors (CIN+)

Vaccine uptake

• Working closely with ISD

• Routinely monitor and publish immunisation uptake rates as for other childhood immunisations

Safety

• MHRA yellow card

• Post-licensing long term studies

• Analysis of UK disease incidence statistics

• Register of vaccination in pregnancy

Attitudinal Research Scotland (December 2007)

Method: qualitative interview study to explore the views of a sample of parents, young people (108) and school teachers undertaken in 7 schools in a range of local authority areas

Key findings:

• Low knowledge levels • Immunisation programme welcomed • Drug safety• Some misconceptions• Information – clear and honest and in a variety of

formats

Scotland

• Catchup immunisation begins this year (girls in S5-S6 & school leavers aged 16-17))

• Screening begins at age 20

• First immunised cohort invited for screening in 2010

Timeline

Age at immunisation 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

S5/S6/left school 16 - 17S3/S4 (13-15 in 2008) 14 - 16

S2 2008 12 - 13S2 2009 12 - 13S2 2010 12 - 13

vaccination first screen second screen

Routine

Year

Immunisation Group

Baseline studies ongoing monitoring of cervical screening samples

Catchup

The impact of the immunisation programme on HPV infection in the population• Baseline information (UK published and

Scottish national prevalence study)

• Ongoing surveillance of HPV infection and circulating genotypes

HPV types and cervical cancerHPV Type Percentage of cervical cancer

cases caused by HPV type Cumulative total

16 58.1% 58.1%

18 15.7% 73.8%

31 4.0% 77.8%

45 2.9% 80.7%

33 4.4% 85.1%

58 1.2% 86.3%

52 0.6% 86.9%

35 1.6% 88.5%

56 1.0% 89.5%

39 0.2% 89.7%

51 0.2% 89.9%

68 0.3% 90.2%

59 0.1% 90.3%

Other 1.4% 91.7%

No type identified 8.3% 100%

Population under surveillanceFemales 20 – 24 years of age – who

• are immunised and attend cervical screening• decline immunisation but attend cervical screening

• are immunised but do not attend cervical screening• are neither immunised nor attend cervical screening

The Cervical Screening population

HPV prevalence and subtypes in a sample from the screened population ongoing

Monitor abnormal smears, and cervical abnormalities and type specific prevalence for cancer precursors (CIN 2&3) periodic

Preserving confidentiality – 1b) LBCs

Source Lab

CHI = Study ID

ISD

CHI = Unique Anon ID= Study ID

SNHPVRL

Study IDSCCRS ID

HPS

Unique Anon ID = Study IDSCCRS ID

HPV Surveillance Board Name: CHI (hand-write here)

Bar-code A (Stick here)

Bar-code B (Stick to specimen pot)

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

COVER UP NAME and CHI with label

Please retain this form for your own records and fax a copy to [Name] at ISD or scan and email to name.surname@email address.

Cervical screening – uptake by age group Scotland 2001/2 to 2006/7

Source ISD: Uptake for Cervical Screening by Age Group: Scotland 1, 1st April 2001 - 31st March 2007 Percentage uptake of females who had a record of a previous smear taken within last 3.5 years

50

55

60

65

70

75

80

85

90

20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59

Age group

Per

cent

age

upta

ke

2002

2007

Surveillance in the non-screened population

Options:• Direct survey approach

• Testing of residual specimens

Postal Testing Kits – non-attenders• “Teaser” mailing – pre-information + opt-out• Postal Testing Kit arrives• Reminder mailing

IssuesLow response rate expectedAcceptabilityEthical issues

– giving results – preserving confidentiality– Not an alternative to screening

Practical issues – organising the survey

HPS

NHS Health Boards

General Practice (GPRN)

Collaboration

• Specialist Virology Laboratory• Statistical Expertise• Cervical cancer screening Service• ISD• HPA

• Coordination - HPS

Proposed ethical approval

• Data Linkage (SCCRS & CHSP-S) – HPS Clinical Governance– Privacy Advisory Committee

• Cervical Screening: HPV Testing + Data issues– HPS Clinical Governance

• Defaulters: Data & HPV Testing– Research Ethics

Fundamentals• Surveillance Year – calendar year from Jan 2009• Overall population

– 20-24 yr olds– Females

• Not vaccinated and do or do not present for CS• Vaccinated and do or do not present for CS

• Timeline – 12 years• 55% of cohort presenting for smears 2006/7• Minimise use of Personally Identifiable Information

(PII)