What is the PRISMA Study?
The PRISMA study is a randomized, double-blind, controlled clinical trial that plans to enroll 5,000 women aged 18 to 30 years old. Its objective is to evaluate the efficacy of a single dose of vaccines against infections by human papillomavirus (HPV) type 16 and 18; this compared to an unvaccinated group.
PRISMA means: Prevention of cervical cancer with a single dose of HPV vaccine in young adult women.
Importance of the PRISMA Study
Recently, the World Health Organization (WHO) launched the “Global Strategy to Eliminate Cervical Cancer as a Public Health Problem”. With this, the WHO wants 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.
In relation to this matter, vaccination against HPV in adult women is not cost-beneficial for the countries. That is, the cost is high and the benefit is lower. This is mainly due to two reasons:
1. The current recommendation in young adult women is to apply three doses of the vaccine.
2. The longer a woman has been sexually active, the less benefit the vaccine offers in protecting against HPV 16 and 18. This is because HPV infection is very common and is acquired in the years after the beginning of sexual life.
So, with the PRISMA Study it is expected to know if a single dose of the HPV vaccine can prevent young adult women from being infected with HPV. In this sense, it will be possible to evaluate the benefit of vaccination up to the age of 30, with the goal of providing data so that the entities that emit recommendations can consider changes in their policies. Likewise, vaccination of young women could reduce the number of years it would take to eliminate cervical cancer as a public health problem in the world.
Objective of the PRISMA Study
Evaluate a single dose of the vaccines against HPV (Cervarix® and Gradasil-9®) compared with no vaccination to protect against incident cervicovaginal HPV type 16/18 infections persisting for six months or more, in women aged 18 to 30 years, who are negative for HPV types 16/18, before and at the time of vaccination.
Design of PRISMA Study
The participants will be randomly assigned to one of the three study groups.
Principal Investigators of PRISMA Study: Dr. Byron Romero, ACIB-FUNIN y Aimée R. Kreimer PhD, NCI.
Sponsor: National Cancer Institute of the United States (NCI).
Institutions participating in the PRISMA Study: National Cancer Institute of the United States (NCI); and Agencia Costarricense de Investigaciones Biomédicas (ACIB-FUNIN).
Approved by the Scientific Ethics Committee: CEC-FUNIN-007-2021.
