Each year, more than 500,000 children under the age of five die of diarrhoea-related illness. One of the most common bacteria causing diarrhoea among children in the developing world is the enterotoxigenic E. coli bacterium (ETEC). The same bacterium is one of the leading causes of diarrhoea among tourists to Africa, Asia and Latin America – it is estimated to cause approximately 12 million cases of diarrhoea among tourists every year. Developing a vaccine against ETEC has long been a goal of the World Health Organization.
The new study, which is about to launch at the University of Helsinki and the Helsinki University Hospital, will test a promising, currently unregistered vaccine, developed to protect from the ETEC bacterium. So far, the ETVAX vaccine has been tested on 140 healthy Swedish adults, and another study is coming to an end in Bangladesh which included 450 children and infants.
“In the studies conducted so far, the vaccine has been very well tolerated, and there have been no more adverse effects than in the placebo control group," says Professor Anu Kantele, who heads the research project.
First participants to fly to Benin this summer
A total of 800 healthy Finns between the ages of 18 and 65 will be invited to join the new study. Half of the participants will be given the vaccine candidate and half a placebo vaccine. The members of each group will be selected at random, and neither the research subjects nor the researchers will know who is a member of which group. The vaccines are administered as oral solutions, taken in two doses at an interval of one to two weeks.
The first research subjects will travel to Benin in West Africa for two weeks in the summer of 2017.
“More specifically, they will travel to the village of Grand Popo, where they will be accommodated in hotels reserved by our study. Our partner, the Finnish-African cultural centre Villa Karo, will organise their programme, including several daytrips which will introduce the fascinating local culture to the travellers," Kantele explains.
While the trip isn’t free for participants, it is much cheaper than typical African package tours of an equivalent length. Participants are given malaria prophylaxis free of charge, but they will have to cover the costs of the necessary vaccinations themselves.
In addition to the trip, the study involves six research appointments, and stool, spit and blood samples will be taken from the participants.
“The purpose of the study is to determine the efficacy of and tolerance for the ETVAX vaccine. In addition to diarrhoea-causing bacteria, the samples collected from the participants will also be screened for changes in the intestinal microbial flora caused by the vaccine and the trip,” says Kantele.
The study will be conducted in cooperation between the University of Helsinki and the HUH Infectious Diseases Clinic along with the University of Gothenburg and Johns Hopkins University. Other partners include the Aava Matkailuklinikka travel clinic, United Medix Laboratories Ltd, Medfiles Ltd, Avetura travel agency and Truly Agency Ltd. The study is funded by Scandinavian Biopharma AB, the manufacturer of the vaccine, the Bill and Melinda Gates Foundation and the international health organisation PATH.
Request to join the research project through the website (in Finnish).
For further information, please contact:
Professor Anu Kantele, University of Helsinki and Helsinki University Hospital