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ARCHIVED - Recommendations on a Human Papillomavirus Immunization Program

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Appendix 3

A literature review was carried out to document aspects of the evaluation of new HPV immunization programs. This literature review aimed to document item 7 of the decision-making model for vaccination(1):

7. Can the various aspects of the program be evaluated?

  • 7.1 Desirability of evaluation to families, professionals, and political authorities
  • 7.2 Availability of information systems to measure coverage and vaccine utilization, quality of vaccination services
  • 7.3 Availability of information systems to measure impact of HPV-related infections
  • 7.4 Availability of information systems for monitoring adverse events associated with vaccine administration
  • 7.5 Availability of systems for linking health outcomes databases, immunization registries and population registries.

This literature review focused on evaluation outcomes specific to HPV vaccination programs. Aspects regarding the safety of licensed vaccines or duration of protection were not reviewed because they are usual outcomes considered in all evaluation studies following vaccine implementation programs. Data and publications related to HPV vaccination programs in developing countries were not reviewed.

The literature search was carried out using MEDLINE and Social Sciences Full Text databases. All publication types, but only articles written in French or English, were included. The search strategy combined the following key words:


MEDLINE, 4 July, 2007

Keywords Used Results Kept
HPV vaccination program AND "Health care quality, access and evaluation"(87) 17 1
HPV immunization program AND "Health care quality, access and evaluation"(87) 131 1
HPV immunization AND Public health evaluation 57 0
HPV vaccine AND evaluation 133 0
HPV vaccine AND strategies 52 3
HPV vaccine AND surveillance 108 1
Human papillomavirus vaccination programs 69 3
HPV AND author: Lehtinen 71 2
HPV AND author: Dillner 129 1
Human papillomavirus AND author: Dillner 150 0


All abstracts of publications from the databases were screened to assess their eligibility for inclusion. When articles could not be excluded on the basis of the abstract, the full-text version was obtained and screened. Additional searches were performed by using references from retrieved articles.

After review of the abstracts of those articles retained, only five met the eligibility criteria for this literature review (i.e. focused on HPV vaccination program evaluation, except for the aspect of safety and duration of protection of the vaccine). All publications were review articles, commentary, opinion pieces or guidelines, and none presented results of original research. The table below presents the main results of the literature review.



First author & Year

Type of publication

Specific HPV vaccination program outcomes to evaluate

Evaluation mechanism suggested to measure outcomes

Short-term outcomes

Long-term outcomes
Lehtinen (2006)(72) Review, commentary, or opinion piece
  • Vaccine efficacy against all cervical lesions independent of the HPV types
  • Changes in the prevalence of vaccine and non-vaccine HPV types in young women
 
  • Serum samples obtained from pregnant women for population-based screening of congenital infections, together with cervical samples collected in organized screening for cervical cancer (Nordic healthcare/health registry infrastructure for long-term follow-up)
 
  • Effectiveness of different methods of implementing mass vaccination:
    • One or both sex vaccination strategies
    • Impact of catch-up vaccination strategies
  • Evaluation of protective efficacy in community randomized trials, as originally described by Brookmeyer and Chen(88).
Arbyn (2007)(89) Appendix to the European Guidelines on Quality Assurance in Cervical Cancer Screening
  • HPV types in the population for early monitoring of "fill-in" phenomena, inappropriate vaccination strategies or other reasons for vaccination failure
  • Protection against cancer measured by comparing the incidence of cervical and other HPV-associated cancers in vaccinated and non-vaccinated cohorts
  • Linkage to cancer registries when possible. In anticipation of such results, estimations of the impact of HPV vaccination on the burden of cervical cancer incidence and mortality must be based on the observed surrogate endpoints (≥ CIN-3)
Saslow(2007)(73) American Cancer Society Guideline  
  • Population- and lesion-based changes in type-specific prevalence of HPV types, including genital and non-genital HPV-associated tumors
 
  • Tools to assist women and providers in making informed decisions about vaccination
   
  • Abnormal Pap tests results, colposcopy referrals, cervical biopsies and genital warts
  • Pap test performance (particularly positive and negative predictive value)
 
 
  • Impact of vaccination on women's screening behaviour and provider behaviour
  • Vaccine acceptability and impact on sexual behaviour
  • Qualitative and quantitative studies
  • Alternative vaccination strategies that increase access to the vaccine and expand the coverage of vaccination in populations
 
  • Use of registries or other tracking data
Soldan (2006)(74) Review, commentary, or opinion piece
  • Monitoring and reporting of HPV infections (vaccine type and non-vaccine type) and HPV-associated diseases
 
  • Utilization of internationally comparable methods; launching of an International HPV Laboratory Network (with a global reference laboratory in Malmö, Sweden) for HPV testing
 
  • Health impact of HPV vaccination programs
  • International standardization of population-based reporting systems for major HPV-associated diseases with a baseline assessment of the total impact of HPV-associated diseases measured before the implementation of vaccination programs
Dillner(2007)(21) Mini-review series on vaccine
  • Levels of protective antibodies in vaccinated subjects
 
  • Studies to define the minimum level of antibody levels required for protection
  • Population coverage of HPV vaccination
 
  • If no HPV vaccination registries are available, the option is to perform sero-epidemiologic surveys to establish the vaccine-induced level of immunity in the population
  • HPV DNA prevalence in sexually active teenage populations
 
  • Sentinel sampling in sexually active teenage populations in clinics offering sexual counselling to the youth to measure whether there is efficient control of HPV types included in the vaccines and whether the prevalence of non-vaccine HPV types is stable
  • Condyloma incidence
 
  • Because 90% of condylomas are caused by HPV types included in the quadrivalent HPV vaccine, the disappearance of condylomas from the sexually active youth population is expected to be the first clinical outcome of HPV vaccination programs
  • Monitoring of whether or not remaining screen-detected lesions are attributable to HPV vaccine types
 
  • HPV typing of lesions as part of screening program (HPV-type data for surveillance can be obtained from local laboratories performing HPV testing)
 
  • HPV-associated malignancies
  • Routine HPV typing of all cases of HPV-associated cancer forms

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