A study by the University of Helsinki aims to determine the effectiveness of a new vaccine against diarrhea caused by the ETEC bacterium in travelers. For the study, 800 Finns are flown to Africa for two weeks.
It is rare for a Finnish laboratory nurse to need to figure out how to ship freight by air to Africa.
However, Project Coordinator Kaisu Räisänen of United Medix Laboratories Ltd. was thrown in at the deep end when she designed a research laboratory in Benin, West Africa.
It’s been quite a ride. The volume of things I had to learn and figure out was enormous, but eventually it all worked out fine, Räisänen sighs and smiles.
United Medix Laboratories (UML) is a partner in the study, led by the University of Helsinki, to test a vaccine against the enterotoxigenic E. coli bacterium (ETEC).
ETEC is one of the most common bacteria causing diarrhea among children in the developing world. In addition, it is one of the leading causes of diarrhea among tourists: it leads to approximately 12 million cases of diarrhea among tourists every year. Thus, there is considerable global demand for a vaccine that protects against ETEC.
A total of 800 healthy Finns between the ages of 18 and 65 will be included in the vaccine study. The study subjects will travel to a small village called Grand Popo in Benin for a period of two weeks. Half of them will receive the study vaccine and the other half will be given a placebo.
The participants are required to provide fecal, saliva and blood samples before and during the trip and after returning to Finland. The samples are examined for diarrhea-causing bacteria as well as for the effects of the vaccine and the trip on intestinal microbes.
This is a significant international study, and I am excited to be part of it. This is also an interesting opportunity for Finnish laboratory nurses to work in a place where the surroundings are exotic but the working environment is Finnish, Räisänen says.
Laboratory built from scratch
UML has set up a laboratory in Benin for preliminary tests on the study subjects’ fecal samples. After the preliminary tests, the frozen samples are sent to UML’s central laboratory in Finland for confirmation and further analyses.
The laboratory in Benin was established from scratch, and even the building is brand new.
We started designing the laboratory facilities in the fall of 2016. The work included learning about the required laboratory permits, purchasing supplies from local suppliers, translating texts into French, and figuring out the most reliable way to transport the samples to Finland, Kaisu Räisänen lists.
The fittings to be installed in the space were determined based on the laboratory blueprint. Then, fittings no longer needed in Finland were shipped to Africa by air.
Everything was ready when the first study subjects arrived in Benin in August 2017. Räisänen says that this would not have been possible without good cooperation and praises the cooperation partners.
Microbiologist and bioanalyst Heli Mathur, who is in charge of the laboratory’s operations, is on site in Benin on a continuous basis. She works with an alternating laboratory nurse, who travels to Benin from Finland for a few months at a time.
More study subjects needed
More than 200 Finnish study subjects have already participated in the vaccine study. We still need more people, says Anu Kantele, Professor of Infectious Diseases at the University of Helsinki, who heads the study.
The participants have really enjoyed their two-week visits. For many, this is a once-in-a-lifetime opportunity to participate in a trip like this, she says.
The study subjects stay in local hotels, and Finnish-African cultural center Villa Karo organizes a wide variety of activities for them. For example, they can join numerous day trips where they learn about the fascinating local culture.
The trip is not free for the participants, but it is still less expensive than many tours of the same duration offered in Africa. The maximum cost per participant is approximately EUR 1,600. The price also includes other required vaccinations.
Participants of all ages are needed for the study. Currently, we would like to have more young people, although we realize that for them, the cost of EUR 1,600 may be a bit much. That is why we offer the trip at a significantly reduced price for participants under 30, Kantele says.
In the studies carried out so far, the ETEC vaccine has been well tolerated and the incidence of adverse effects has been the same as in the placebo group. Of course, study subjects may still get tourist diarrhea – just like the approximately 350,000 Finns who travel to areas with poor sanitation levels every year.
The project workload was a surprise
When the vaccine manufacturer asked Anu Kantele if she was interested in leading the study project, she had no idea what she was getting herself into.
Kantele admits that the heavy workload of the project took her by surprise and has also made free time scarce.
This is a sizeable project, which has taught the staff a great deal. Ultimately, only a small portion of the issues we have encountered deal with medical matters: the list of various practical issues is endless, she says.
On the other hand, the way of life in Africa is more laid-back than in Finland.
In Benin, I never set my alarm clock. That in itself is a luxury! Kantele says with a chuckle.
The study is carried out in cooperation with researchers from the University of Gothenburg, Sweden, and Johns Hopkins University in the USA. The study is sponsored by the vaccine manufacturer Scandinavian Biopharma AB from Sweden and PATH, an international health innovation organization funded by the Bill and Melinda Gates Foundation.
The participants’ study visits take place at the Travel Clinic of the Aava Medical Center and at the joint vaccine research center of HUCH and the University of Helsinki. In total, the project employs dozens of people on a full-time basis.
The goal is to recruit all 800 study subjects needed by the end of this year. If all goes well, an ETEC vaccine may be available on the market in five years.
Tourist diarrhea is usually not a serious illness, although it is inconvenient for those travelers affected. However, approximately half a million children each year die from diarrhea in developing countries, and ETEC is one of the most significant causes.
Thus, we are developing the vaccine for children in developing countries, in particular, Kantele emphasizes.
Challenging sample logistics
The climate in Benin is hot and humid. It is over +30 Celsius even in the shade, and the weather alternates between scorching sunshine and heavy rain.
The conditions resemble those inside an incubator: if a fecal sample is left outside for even a second, microbes in it will multiply explosively. Therefore, the sample logistics in Benin ensures that the study subjects’ diarrhea samples are recovered and refrigerated quickly.
The study subjects carry with them at all times a pouch containing the supplies needed for collecting a fecal sample. When they go on trips away from Grand Popo, they bring along a cooler for keeping any diarrhea samples cold. At night, a moped courier picks up the samples from the hotels and delivers them to the laboratory.
In the lab, there are two freezers to store the samples at -70 degrees Celsius. Backup generators will keep the freezers operating during power outages – which are common in the area.
Another critical aspect is shipping the frozen samples from Benin to Finland, where the results are confirmed and the samples are stored for further analysis.
The samples stored in dry ice usually arrive in Finland the day after shipment. The temperature of the frozen samples is monitored carefully during shipment. So far, all shipments have successfully arrived frozen at UML’s central laboratory.
The article was first published in issue 1 2018 of Mylab’s Nyt magazine.