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

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.

Sex

Female

Minimum age

25 Years

Maximum age

45 Years

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.

• DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263