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This film has been made in the frame of the clinical study Bilhvax 3, according to the
information letter. It addresses populations and parents of the children selected for the
clinical trial in the Saint-Louis region (Senegal)
This communication tool has been used during information sessions for the phase 3 clinical
trial of the vaccine candidate against schistosomiasis.
[Child singing a Senegalese children song]
"Discussion under the Mbar" Clinical Trial Bilhvax 3
-Cheikh! Hey Cheikh! -Yes Mom?
-Cheikh, I knew I was going to find you near the water! What are you doing here? Are you
trying to catch some fish? -The water is evil, so I am hitting it with
mud balls. -He says he wants to punish the water!
-So, you are punishing the water? -He says the water is bad for kids.
-Because of this water, I am peeing blood since many days, but I was ashamed to say
it. -Come kids; let's go under the Mbar.
-You know Lydie, women from the village have come to talk to me. They came to know about
schistosomiasis, is a very common disease in the village and this whole region.
-Yes Sokhna, it a serious issue, for the village and even at the region scale.
After Malaria, it is the most important disease!
- The people that came to take our urine told us that it is in the water that we catch this
disease. - One can catch this disease while bathing,
and it ends up as blood in the urine. Espoir pour la Santé (EPLS) has come to our village
to collect urine from the kids to screen for the presence of schistosomiasis.
- Yet there is a drug, Praziquantel, that cures schistosomiasis!
- True, but if you go back to the water, the disease can hit you again.
- What can we do then? - A vaccine would be great.
- Yourself Cheikh, when you were a kid, you have been vaccinated. It's the EPI (Expanded
Program on Immunization) program that takes care of that.
- Vaccines prevent you from catching certain diseases.
- What is a vaccine? - A vaccine is something that develops your
immunity. - And what is immunity?
- Immunity protects the body like soldiers protect their country.
- Hey look! There comes Mr. Senghor, our school director.
- As Salam Aleikum (may peace come upon you). I am sorry; I went to close the school gate.
Cheikh, here you are! Our village chief just came back with the people from Espoir Pour
La Santé. They have the results of the screening they had carried out a few weeks ago.
- Look, here they come! - Iba, our village chief is coming back from
Saint-Louis with the people in charge of the study.
- Yes here they are, with Guindo from EPLS, and the others.
- As Salam Aleikum! (May peace come upon you) - Wa aleikum assalam! (May it come upon you
likewise) - How do you do?
- Please, have a seat
- How was your journey? Was the road good? - Thank God! With the help of Zakaria, we
are not even tired from the drive. There he is, he is bringing us the tea.
[Guitar playing]
- My dear friends let me introduce to you Dr. Jean-Pierre and Dr. Cheikh.
- There will be two investigators in this study, Dr. Cheikh and myself.
[Dr. Cheikh repeats sentence in Wolof language] - So you are the instigator doctor?
- In-ves-ti-gator! It is a doctor that takes care of the children for the whole study period.
[Dr. Cheikh repeats sentence in Wolof language] - What is "ESPOIR"? (Hope in French)
- Espoir Pour la Santé, also known as EPLS. It is an organization that researches health
issues, we study diseases. We come today with great news: your village has been chosen to
participate in the study. -Why was our village chosen?
-You want to know why we have chosen your village Cheikh? Did you forget the time when
we came to collect urine samples from the children? The analyses we did on these showed
us that there was much blood in many of the children's urine samples, indicating that
they have bilharzia (schistosomiasis) - The Doctors told us that this disease spreads
quickly. - We chose your village because the disease
is clearly present here. We've discussed it with the village chief.
- However, you promised us that you would make sure to abide to the protocol!
- But wait, what is a protocol? - A protocol is a set of written rules that
the doctor strictly follows to carry out the clinical trial.
- Before this trial starts, the protocol has been thoroughly examined by a group of experts:
the ethical committee. [Dr. Cheikh repeats sentence in Wolof language]
- This committee made sure that the protocol is in accordance with the international rules.
[Dr. Cheikh repeats sentence in Wolof language] - Yes, it is the Senegalese ethical committee
(CNRS) that agreed for the study to be carried out and authorized us to work in this village.
- French and Senegalese researchers have come out together with a vaccine candidate called
Bilhvax. This vaccine is intended to help treating schistosomiasis. To prove its efficacy,
we are starting a phase 3 trial. This is why the program is called "Bilhvax 3".
- We have previously demonstrated the vaccine safety in past trials.
- Oh yes, you are right! When the medical team came last time, little Rokhaya has participated
in their study. Sarah, go and fetch your sister. - In this study, there will be two groups
of 125 children each. One group will receive Praziquantel and vaccine candidate Bilhvax,
the second will only receive Praziquantel. It is like a drawing of lots: none of the
group members will know what product he or she has received, and neither the doctors.
This is called double blinding. - We ask you for your participation in this
study. You are not forced to participate, you are free to chose to do it, and also to
stop and withdraw from the study whenever you feel like it.
- To carry out this work, two documents are necessary. You need to be aware of their importance.
First document is the written informed consent. It is this document here. The written informed
consent is a very important document. It has been written in French, but to make sure that
every one fully understands its meaning and content, it has also been translated in Wolof,
Serer, Pular and Diola. However, before signing it, I need to show you another important document:
"the patient's understanding". The entire study procedure is explained in this letter.
How we are going to proceed for this study, what we are going to do to the children, etc.
The explanations given in this letter are also translated in local languages: Wolof,
Diola, Sere, and Pular. Before the inclusion of your child, we need to obtain the agreement
and signature of his father, his mother or his legal guardian. The signature of this
document proves that the parents or legal guardian have accepted the participation of
their child to the study. - EPLS team will come back in a few days and
bring both documents (the written informed consent) to the parents or the child's legal
guardian. Like this, they would have had a period of reflection to consider the child's
participation and fully understand the document's content. We remain at your disposal if you
need any clarifications. - Tell me Doctor, what do we have to sign?
And who signs? - It is the French version that needs to be
signed by at least one of the parents or the legal guardian of the child, according to
the Senegalese law. If none of the parents can read and write, they will sign their own
way. A legal representative can sign with him, if he wishes to. The investigator will
also sign the document. But each and every one has the individual free will to choose
to participate. - The Bilhvax village committee agrees on
the participation of its people to the clinical trial. Almost all its members are today present:
you Lydie, our nurse, no one can deny your important role in this study. And you, Sokhna,
our Mbotaye mother, you have been a wonderful communicator about the study among the village.
I can even say you were the most active amongst all women! And you Senghor, you are the first
to notice what ailments strike our children, since you are the one that spend most time
with them. Bouba is not here today; he is in Saint-Louis (Ndar), participating in a
conference with the Parent's group president. As for Djibril, I would like to apologize
on his behalf for his absence. He is the president of our health committee. He unfortunately
was not able to join us because of family issues. With God will, when he comes back
to the village, we will report all that has been said today!
- Like other children from the village, you will be part of this medical study, if you
wish to, and if your parents agree to this. [Dr. Cheikh repeats sentence in Wolof language]
- How long will it last? - This study will last for a bit more than
3 years. - So long?
- Why is it so long? - The study will start at the first urine
analysis. It will last 3 and half years. You Cheikh, like other selected children fro the
school, a doctor will see you 11 times during this period.
- Eleven times! - But what is the purpose of this study?
- This study has two objectives. The first is to know if the vaccine works (efficacy).
If the disease happens, it will not be severe, showing that the vaccine is effective. The
second aim of this study is to continue our previous work, to know what happens in the
body after immunization. We want to observe if there are any side effects.
- Previous studies have shown that the vaccine candidate Bilhvax was well tolerated by the
body. However, we have noticed some side effects that were not serious. They are the same reactions
sometimes observed after any vaccination.
- Salam aleikum! - [Everybody] Wa aleikum assalam!
- Rokhaya, we asked you to join us because you have participated in a previous Bilhvax
program when you were young. - Yes, it's true. I've participated in previous
Bilhvax studies with my older sister. I've received a shot and there were no problems.
When I was vaccinated, I had some itching at the vaccination site, and my body felt
warm. After that, everything was all right, and there weren't any other issues.
- The drug called Praziquantel will be used to treat schistosomiasis during the study.
As you may know, its uptake sometimes induces benign side effects: vomiting, diarrhea, nausea,
itching, headaches, abdominal pain, etc. But all these symptoms usually quickly disappear.
- So, what guarantees children security during the trial?
- We are going to take care of the child's health for the whole duration of the study.
And we will ensure its body safety during this period. If he is sick, one of the study
investigators will take care of him and treat him appropriately.
- Doctor, are there any other risks? - With the vaccine, there may be other risks
that we don't know. But the doctors' constant presence and the arrangements for the study
will ensure that such situations will be duly managed and child's security will be guaranteed.
- Everything that has to do with the children will be our essential preoccupation for the
duration of this study. - What is the advantage for us to participate
in this study? - There is no financial compensation in this
study, as it is not authorized for pediatric clinical trials.
- And for the other children, what will be done?
- The medical observation will be beneficial for all school children, even those not included.
The sponsor of this study has made sure that all village children take advantage of the
program. This is the reason why we are all going to sit together and come out with the
most beneficial way to compensate the village community.
- So there are advantages for the village! - So we could have a basketball ground!
- Sure, or a building in the school, a health center, or another project that the village needs.
- Ah! Mr. Drame! - Assalam Aleikum
- Wa aleikum Salam - Cheikh! Good morning! Madam, please have
a seat.
- I am in the doctors' office with my parents. We gave you the written informed consent.
Do you agree on the participation of your child to the clinical study Bilhvax 3?
- Yes, we received the documents and we read them thoroughly. Yes, I agree to the participation
of my child to the study. - And you Madam, what do you think about it?
- I also agree, because Cheikh told me he wanted to be a part of the program.
- So we are going to sign two copies of the written informed consent. One is for you to
keep, and the other is for EPLS. - Come here Cheikh, we are going to examine
you.
- Look, here is where the weigh you. Then, they measure you. After that, they examine
you. Then, they take your temperature; it does not hurt. They check for your breathing,
and they look into your eyes. Then, they feel your pulse. After that, they measure your
arterial pressure. They will put on your tummy a product that is a bit cold. You will see
a funny machine, called an ultrasound machine. With it, the doctors see inside your belly,
but it does not hurt at all! They give you a pot, to pee in it. They apply a small plaster.
They will withdraw blood from your arm.
[Later...]
-They are going to vaccinate you. You will receive a shot. It is like a mosquito bite.
It did not hurt me.