What is the ESCUDDO Project?
The ESCUDDO Project is a randomized clinical trial that began in November 2017 and included 20,330 female adolescents between 12 and 16 years of age from 202 districts of Costa Rica. Its objective is to evaluate whether a single dose of the approved HPV vaccines (Cervarix® and Gradasil-9®) is equally effective as two doses.
ESCUDDO means: Comparative Study of One and Two Doses of Vaccines Against Human Papillomavirus (HPV).
Importance of the ESCUDDO Project
Recently, the World Health Organization (WHO) launched the “Global Strategy to Eliminate Cervical Cancer as a Public Health Problem”. With this, the WHO aims to ensure that all girls in the world are vaccinated against HPV. Also, that all women over the age of 30 be screened and treated; this in case of having precancerous lesions.
Vaccination of adolescent females against HPV is the most effective long-term intervention to reduce the risk of cervical cancer. However, the majority of adolescent girls in the countries with the highest cervical cancer death rates are not being vaccinated. The foregoing, due to cost and logistics considerations, related to implementing multidose programs in adolescents, which prevents progress in reducing this preventable cancer.
With this, the ESCUDDO Project seeks to provide the necessary scientific evidence to modify global policies towards single-dose HPV vaccination programs.
¡One single dose could be enough!
Objective of the ESCUDDO Project
1. To evaluate the non-inferiority of one dose versus two doses of each of the two HPV vaccines.
2. To estimate the efficacy of one dose of the vaccine versus no vaccination.
Design of ESCUDDO Project
This section involves two main components:
1. Clinical trial.
- Participation of adolescent women from 12 to 16 years of age.
- These women attend semi-annual visits for five years.
- Will compare the protection conferred by vaccination with one dose and two doses of the HPV vaccine.
2. Epidemiological surveys.
- Participation of women from 16 to 21 years of age.
- These women attend two visits six months apart.
- Will determine the presence of HPV among unvaccinated women.
- An epidemiological survey was included at the beginning of the ESCUDDO Project and another will be included at the end.
Principal Investigators of ESCUDDO Study:MSc. Carolina Porras Gutiérrez, ACIB-FUNIN and Aimee R. Kraimer. Ph.D, NCI.
Sponsor: National Cancer Institute of United States (NCI).
Institutions participating in the ESCUDDO Project: National Cancer Institute of United States (NCI); Agencia Costarricense de Investigaciones Biomédicas (ACIB-FUNIN); International Agency for Research on Cancer; and World Health Organization.
Approved by the Scientific Ethics Committee: CEC-ICIC-E093-2017.
Registration in ClinicalTrials.gov NCT03180034
Clinics and Doctors of the ESCUDDO Project
