ESCUDDO is the name that we have assigned to a clinical study, it means Comparative Study of One and Two Doses of the vaccine against Human Papilloma Virus.

At the end of the study, the committees that supervise the study will give the recommendation as to whether or not it is necessary to apply the second dose and the recommendations given by these committees will be followed.

The study was designed to demonstrate that a single dose of the vaccine is as effective as two or three. Ideally, all the participants should remain until the end of the study so that the number of women we are going to compare remains stable, as well as being able to monitor the variations that may arise in the defenses of one and the other participants. Participation is voluntary and participants can withdraw at any time they wish. And the participants who withdraw from the study can request information on what type of vaccine they received and the number of doses, this information will be given to them when it is available. La participación es voluntaria y las participantes pueden retirarse en el momento que lo deseen. Y las participantes que se retiran del estudio pueden solicitar información de cuál tipo de vacuna recibieron y el número de dosis, esta información se les dará en el momento que esté disponible.

If there is a pregnancy after the application of any vaccine, you will not be able to receive more vaccines until the pregnancy has ended.

If an adolescent has already started sexual activity and is vaccinated, nothing will happen that could harm her, if she had already been infected with any of the viruses, the vaccine will not cause any harm, it simply would not help against those viruses. Vaccines protect against more than one virus; the vaccine may help protect you from one of the viruses that you have not been infected with.

Vaccination in the study will be given to all study participants regardless of whether or not they have engaged in sexual activity and the study personnel will never ask you if you have already engaged in sexual activity.

Only participants over the age of 15 or more, when they answer the self-administered questionnaire on the tablet, will answer, if they wish, some questions regarding sexual activity. This questionnaire is confidential and the information is not available to the study personnel who attend them.

If it is shown that any participant suffers any damage caused by their participation in the study, there is an insurance policy that covers the participants.

In the documents (brochures, informed consent, informed assent, web address, social networks, etc.) the participants can find different telephone numbers and addresses of offices where they can attend or call to request more information at any time they wish. The free telephone line 800- DOCTORA will also be enabled where you can answer your questions. También se encontrará habilitada la línea telefónica gratuita 800_ DOCTORA donde podrán evacuar sus dudas.

Because it is the minimum follow-up time requested by the regulatory authorities to be able to make changes in the recommendations on the number of vaccine doses to apply. However, if necessary, longer-term follow-up could be extended to a sub-group of participants.

This vaccine will be applied because, for the purposes of protection against cervical cancer, it is comparable to the Gardasil or Gardasil-9 vaccine.

The vaccine is not contraindicated in people who have already been infected with HPV; however, the benefit in preventing HPV infections diminishes as the years pass after the onset of sexual activity. The maximum benefit is obtained before the start of sexual activity. El máximo beneficio se obtiene antes del inicio de la actividad sexual.

In Costa Rica we have a group of professionals at the Costa Rican Biomedical Research Agency (ACIB) who have a lot of experience in the field of research. A very important study on HPV and vaccines was carried out in Costa Rica a few years ago. The results of this study will be very important, so it is essential that the professional group conducting it have the necessary experience.

Demonstrating that one dose of vaccine protects the same as two, means that people with a single dose will be protected and this would lower vaccination costs, which would allow countries to vaccinate more women or invest the resources saved in other issues of health. In addition, it is currently in poor countries where more women die from this type of cancer, this would help them to introduce vaccination.

The ADACEL vaccine is a benefit that women who receive only one dose of the HPV vaccine will obtain. This vaccine is indicated for the prevention of tetanus, diphtheria and pertussis, the latter causing whooping cough. Whooping cough, despite good vaccination coverage, persists as a frequent problem in the population. It has been shown that the immunity provided by the vaccine only lasts 5 to 10 years after completing the vaccination scheme. This situation leaves adolescents and adults unprotected. It is important to mention that, in addition, these individuals can be a possible source of infection for susceptible children. PAHO is recommending reinforcement in adolescence, a recommendation that many countries have already adopted.

In a double-blind clinical trial, the participating individuals and the investigators are unaware of the treatment administered. The double-blind method is a tool that is used to prevent the results of an investigation from being influenced by bias, that is, by the tendency that the participating people might have to act differently or perceive things differently if they know which treatment they received or researchers observing or following people in a different manner because of the different treatments they received, based on their own judgments.

Since the study is double-blind and this helps prevent the results from being influenced by observer bias, it is important to keep the blind until the end of the study, so it is not possible to know which vaccine was administered before the end of the study.