What is Dukoral?
Dukoral is a vaccine that is available as a suspension in a vial. It contains four different inactivated (killed) strains (types) of the bacterium as active ingredients Vibrio cholerae (V.cholerae) serotype O1 and part of a toxin derived from one of these strains. Dukoral is supplied with granules in sachets to prepare the oral suspension.
What is Dukoral used for?
Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is contracted from contaminated food or water and causes severe diarrhea). Dukoral is used in adults, adolescents and children from two years of age who intend to travel to high-risk areas. Dukoral should be administered according to official recommendations, taking into account the locations of cholera and the risk of contract the disease. Dukoral is not a substitute for normal protective measures against cholera including attention to dietary advice and hygiene rules.
The medicine can only be obtained with a prescription.
How is Dukoral used?
Dukoral is taken orally. In adults and children from six years of age, Dukoral is given in two doses, one to six weeks apart. Children between two and six years of age should be given three doses. observing an interval of one to six weeks between one dose and another. The cycle must be completed at least one week before possible exposure to cholera. For continued protection against cholera, a single booster dose is recommended after two years for adults and children aged six years and above and after six months for children aged two to six.
The vaccine is prepared by dissolving the granules in a glass of water to prepare an effervescent solution and adding the contents of the vial. Once prepared, the suspension should be drunk within two hours. Food, drinks and other oral medications should be avoided. for one "hour before and one" hour after each dose of Dukoral.
How does Dukoral work?
Dukoral is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defenses) to protect itself from disease. Dukoral contains small amounts of killed cholera bacteria and a part of the cholera toxin called the "B subunit." This subunit is not itself. self toxic.
When a person receives the vaccine, the immune system recognizes the bacteria and the toxin and makes antibodies against them. In the future, the immune system will be able to produce antibodies faster if it is exposed to cholera bacteria. These antibodies help protect against cholera by preventing bacteria and toxins from adhering to the walls of the intestine and entering the body's cells.
In Dukoral, the cholera toxin is produced by a method called 'recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it capable of producing the toxin.
How has Dukoral been studied?
Since Dukoral has been used in Sweden since 1991, the company presented the results of three main studies that had already been conducted to support the use of Dukoral. The company also presented data from the scientific literature.
The three main studies included a total of nearly 113,000 people. In all three studies, the effectiveness of Dukoral, given in two or three doses, was compared to that of placebo (a fake vaccine). The studies were conducted in areas where cholera is found. The first study involved more of 89,000 people in Bangladesh and compared the effects of Dukoral with the effects of the vaccine without the toxin and with those of placebo.In this study, Dukoral was produced using a cholera toxin extracted from cholera bacteria in place of the more recent recombinant toxin. The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru. People in the latest study also received a booster dose 10 to 12 months later. In all three studies, the main measure of effectiveness was the 'protective efficacy' of the vaccine, calculated by comparing the number of people participating in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Another study was being conducted to show that Dukoral was able to produce antibodies in people who do not come from areas where cholera is found. The company also presented information on "using Dukoral to prevent a severe type of traveler's diarrhea caused by a bacterium called"Escherichia coli enterotoxigenic "
What benefit has Dukoral shown during the studies?
In the Bangladesh study, the protective efficacy of Dukoral was 85% in the first six months of follow-up. The duration of vaccine protection was different for adults and children, six months in children and two years in adults. In adults, two doses of the vaccine demonstrated the same efficacy as three doses. In the first of the two studies in Peru, the protective efficacy of Dukoral was 85% for the first five months of follow-up. The other study in Peru showed that, after a booster dose, the protective efficacy of Dukoral during the second year of follow-up was 61%.
The information presented was not sufficient to support the use of Dukoral for traveler's diarrhea.
What is the risk associated with Dukoral?
Side effects of Dukoral are rare. However, the following side effects observed in 1 to 10 out of 1 000 patients were noted: headache, diarrhea, abdominal (tummy) pain, cramps, gurgling (gas) or malaise. For the full list of side effects reported with Dukoral, see the Package Leaflet.
Dukoral must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other substances or to formaldehyde. Its use should be postponed in patients with short-lived diseases of the stomach or intestines and in patients with fever.
Why has Dukoral been approved?
The Committee for Medicinal Products for Human Use (CHMP) took into account that the risk of cholera for ordinary tourists is low but that Dukoral could be important for some groups, such as eg. health workers in cholera outbreaks. The Committee decided that Dukoral's benefits are greater than its risks for active immunization against the disease caused by serogroup O1 of the V.cholerae. The committee recommended the granting of a marketing authorization for Dukoral.
Other information about Dukoral:
On 28 April 2004, the European Commission granted SBL Vaccin AB a "Marketing Authorization" for Dukoral, valid throughout the European Union. The "Marketing Authorization" was renewed on 28 April 2009.
For the full version of Dukoral's EPAR click here.
Last update of this summary: 04-2009.
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