Dukoral®
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Description

Dukoral® is a drinkable vaccine with a documented protective effect against diarrhea caused by cholera, as well as traveler’s diarrhea in Canada. The vaccine stimulates a protective immune response in the gut and has a demonstrated protective efficacy against cholera of approximately 84-86%.

 

Dukoral® was first licensed in 1991 and is now licensed in 65 countries. It is presently the only internationally licensed oral cholera vaccine. To date, over 15 million doses of Dukoral® have been supplied with very few adverse events reported.

 

Dukoral® consists of the following two main vaccine components:

  • Heat- and formalin-killed whole-cell V. cholerae O1 Classical and El Tor vibrios. These induce mucosal IgA antibacterial immunity, which interferes with colonization and adherence of cholera vibrios to the intestinal epithelium.
  • The non-toxic B subunit-binding portion of the cholera toxin (cholera B subunit), which is known to induce protective antitoxic IgA immunity

 

As of the third quarter of 2011, Dukoral batches will be formulated using a higher content of bacteria, 125x109 compared to 100x109 bacteria per vaccine dose. The antigen content stays within the approved range and what has been proven to be efficacious and safe in a large number of clinical trials conducted with Dukoral. The dosage is not affected. The reason for this change is to increase the safety margin that the product fully meets the potency requirements over the entire shelf life. For further questions please contact info@crucell.com.

About Cholera

Cholera is an acute intestinal infection often caused by eating food or drinking water contaminated with the Vibrio cholerae bacteria. In its most severe form, the disease can cause a sudden onset of acute watery diarrhea that can lead to severe dehydration, kidney failure and ultimately death if treatment is not promptly given. Most people infected with cholera do not develop any symptoms, although the bacterium is present in their feces for 7-14 days, potentially infecting other individuals.

 

Morbidity and mortality

Cholera remains a global threat, particularly in developing countries where access to safe drinking water and adequate sanitation cannot be guaranteed. The number of cholera cases reported to the WHO in 2010 were more than to 300,000 cases, including more than 7500 deaths. It is likely the morbidity and mortality caused by V. cholerae is grossly underreported – less than 10% - to the WHO. As a result, the true burden of this disease is estimated to be 3-5 million cases.1

 

Geographical distribution

Cholera remains a global threat. Almost every developing country, where poor sanitary conditions prevail, faces cholera outbreaks and the threat of a cholera epidemic. Altogether seven cholera pandemics have been reported. The latest, still ongoing pandemic started in Indonesia in 1961, spreading to Africa in 1971 and to the Americas in 1991. Cholera is considered endemic in many countries.

 

 

Reported cholera cases 2004 - 20102

 

Transmission

Cholera is spread by fecal contamination of water and food, linked to poor sanitation. Person-to-person transmission of cholera is rare.

 

Symptoms

About 75% of people infected with cholera do not develop symptoms. Of those who do develop symptoms, 80% are considered mild to moderate cases and 10 to 20% are severely affected. Children and the elderly are most susceptible.

 

Symptoms include acute, profuse watery diarrhea (“rice-water stools”) and often vomiting. Tachycardia, loss of skin turgor, dry mucous membranes, hypotension and thirst are often signs of dehydration. In extreme cases and if left untreated, severe dehydration can lead to kidney failure and death. Cholera is one of the most rapidly fatal infectious illnesses known.

 

Treatment and prevention

Rehydration is the key form of treatment. Mild or moderate dehydration can be treated with simple oral rehydration solutions containing salts and glucose. Severe cases of dehydration require treatment with intravenous fluids and antibiotics. WHO recommends that antibiotics are only used in severe cases as overuse of antibiotics has led to the emergence of multiresistant strains, some of which where found to be highly virulent.

 

Cholera can be prevented through the provision of clean water and proper sanitation. For travelers to endemic areas, it is recommended to “boil it, cook it, peel it, or forget it” and to avoid eating high-risk foods. An oral vaccine with registrations, across the globe, is currently available on the market and is suitable for travelers.

 

1 Source: WHO Cholera factsheet 107 [August 2011]

2 Source: Crucell (2010). Data on file.; WHO (2005). Cholera, 2004. Weekly epidemiological record 2005; 80: 261–268.; WHO (2009). Cholera: global surveillance summary, 2008. Weekly epidemiological record 2009; 84: 309–324.



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