FASTER-Tlalpan Study

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Brief Title

FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program

Official Title

HPV Vaccination Impact on Cervical Cancer Screening Program: FASTER-Tlalpan Study in Mexico

Brief Summary

      Objective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary
      screening program to extend screening intervals.

      Materials and methods. A total of 3,000 women aged 25-45 years, attending the regular
      cervical cancer-screening program in primary health care services in Tlalpan, Mexico City,
      will be invited to the study. Eligible participants will be assigned to one of three
      comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine
      and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening.
      Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will
      be conducted to estimate safety profiles at different screening intervals; participants will
      undergo diagnosis confirmation and treatment as necessary.

      Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical
      cancer prevention programs. It will offer valuable information on potential benefits of
      combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.
    

Detailed Description

      Cervical cancer mortality is a reflection of social inequity in health care. Globally,
      266,000 women die from cervical cancer annually, and 85% of these deaths occur in low- and
      middle income countries (LMIC).1,2 Persistent infection with high-risk human papillomavirus
      (hrHPV) is a necessary cause of cervical cancer.3,4 HPV16 and HPV18 are responsible for 70%
      of squamous cell carcinomas, and in conjunction with HPV45, cause 94.2% of cervical
      adenocarcinomas.4 The introduction of HPV vaccines will change the epidemiology of
      HPV-related cancers. However, it may take 30 years to observe the desired benefits of
      widespread vaccination when vaccinated cohorts reach the peak ages at which cervical cancer
      cases currently occur (e.g. women aged 40-50 years).5 As of August 2015, 84 countries and
      territories had national public-sector HPV immunization programs and 38 had pilot programs.6
      These programs mainly target adolescent girls to obtain the greatest cost-benefit ratio,7
      considering the initial price of the vaccine (>$100 US per dose).8,9 Women older than age 25
      are also vulnerable to new HPV infections10 and could also be vaccinated depending on
      country-specific resource availability.

      Recent results of Phase III HPV vaccination trials documented that the vaccine's efficacy
      among adult women is excellent (efficacy >80% to prevent resultant HPV-related cervical
      intraepithelial neoplasia).11,12 Additionally, current vaccines protect against both HPV16
      and HPV18 as well as provide cross-protection against other HPV types, particularly types 31
      and 45.13 Broad-spectrum protection such as this may lower the need for subsequent screening,
      warrant longer screening intervals than those currently used, and offer novel prevention
      policies against HPV-related cancers. The combination of vaccination and screening strategies
      to prevent cervical cancer may be particularly appropriate in countries with high incidence
      of cervical cancer that have already implemented hrHPV-based screening programs. These
      criteria are satisfied in Mexico.14 A broader age range of females in population-based HPV
      vaccination programs could have direct benefits for vaccinated females, and indirect benefits
      for non-vaccinated females and male sexual partners via increased herd immunity to reduce
      HPV-related cancers.15 Based on the high efficacy of the HPV vaccine in older women, a novel
      strategy combining vaccination and screening, HPV FASTER, has been proposed.16 In accordance
      with this proposal, HPV vaccination of women in a broad age range can offer protection to
      women who are not currently infected, but also can protect against subsequent re-infection.16
      As a result, a combined strategy of HPV vaccination and screening may reduce the lifetime
      number of screens used by the current hrHPV-based screening programs. If a screening and
      vaccination strategy is widely adopted, we expect promising results. This strategy has the
      potential to: 1) mitigate the screening demand on both women and health services by extending
      screening intervals; 2) improve the cost-benefit balance of screening programs; and 3)
      provide greater protection and quality of life to a large number of women through a reduction
      in cervical cancer.17 An intervention such as this may not only save many lives in the next
      30 years but also be cost-effective.

      However, the data on efficacy of HPV vaccination in older women to reduce cervical cancer
      risk, and not just the risk of precancerous lesions, are lacking. That is, there is currently
      insufficient knowledge regarding the role of HPV vaccination in older women to permit
      screening intervals to be extend safely following a negative screen (Figure 1).

      A significant challenge for HPV-vaccine uptake is the number of doses in the standard vaccine
      schedule. Although licensed in some countries for use among older individuals, national HPV
      vaccination programs target teenagers and young adults. Recent studies found that fewer than
      three doses of the two commercially available prophylactic HPV vaccines seem to provide
      similar protection against cervical HPV16 and HPV18 infections as the three-dose schedule in
      women younger than 25 years old. 18,19 Herein we propose a population-based study to assess
      the efficacy of a 2-dose HPV vaccination with [HPV16/18 AS04-adjuvanted vaccine (Cervarix ®)
      and HPV 6/11/16/18 vaccine (Gardasil®)] against HPV-persistent infection and HPV-related
      cervical disease in older women between 25 and 45 years of age attending clinics for
      hrHPV-based screening.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Inicidence 6-month persistent infection of HPV 16 or HPV 18 in women aged between 25-45

Secondary Outcome

 Incidence of cervical intraepitelial neoplasia of grade 2 in women aged between 25-45 years

Condition

Cervical Intraepithelial Neoplasia

Intervention

CERVARIX

Study Arms / Comparison Groups

 CERVARIX
Description:  hrHPV-based screening and HPV16/18 L1 VLP AS04 vaccine (Cervarix®) group according to a two-dose schedule (0-12 months)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

3000

Start Date

January 3, 2017

Completion Date

December 15, 2018

Primary Completion Date

December 15, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Female aged 25 to 45 years at the time of the first vaccine dose.

          -  Willing to comply with the requirements of the protocol (e.g., return for follow-up
             visits).

          -  Written informed consent prior to enrollment.

        Exclusion Criteria:

          -  Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not
             breastfeeding to enter the study.

          -  Planning to become pregnant or planning to discontinue contraceptive precautions
             during the first twelve months of the study (months 0-12).

          -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
             by any component of the vaccine.

          -  Any other medical condition or disease that could compromise the life of the
             participant during enrollment in the study.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days prior to the first dose of the study vaccine.

          -  Previous vaccination against human papillomavirus.

          -  History of cervical cancer or hysterectomy.
      

Gender

Female

Ages

25 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

JORGE SALMERON, PhD, , 

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT03105856

Organization ID

1417


Responsible Party

Principal Investigator

Study Sponsor

Instituto Nacional de Salud Publica, Mexico


Study Sponsor

JORGE SALMERON, PhD, Principal Investigator, Instituto Nacional de Salud Publica, Mexico


Verification Date

August 2020