DUKORAL® Cholera Vaccine Clinical Trials, Dosage, Indication, Side Effects
Valneva SE's DUKORAL® is an oral, inactivated vaccine for preventing diarrhea caused by Vibrio cholerae and/or heat-labile toxin-producing enterotoxigenic Escherichia coli (ETEC). Since the 1980s, either killed or live oral cholera vaccines (OCVs) have been developed, and efficacy and effectiveness studies have been conducted. DUKORAL contains four different inactivated strains (types) of V. cholerae serotype O1 and part of a toxin from one of these strains as active ingredients, according to the European Medicines Agency (EMA). Dukoral is a vaccine administered orally to protect individuals against cholera. DUKORAL suspension and effervescent granules for oral suspension. DUKORAL's ATC code: J07AE01, J07AE02, J07AE51.
The World Health Organization (WHO) has prequalified the DUKORAL vaccine. It is authorized in Europe, Australia, Canada, Ireland, Mayotte, New Zealand, Switzerland, Thailand, and the United Kingdom to protect people against cholera and Enterotoxigenic Escherichia coli (ETEC). The EMA (EMEA/H/C/000476) states that Dukoral is used in individuals aged 2 years who will be visiting areas with a high risk of cholera. The WHO announced on February 12, 2024, that global demand for OCVs (74 million) has exceeded supply (38 million). Valneva announced on November 7, 2024, that DUKORAL sales in the third quarter of 2024 increased by 85% year-over-year, as marketing investments resumed following a successful regulatory inspection of the Company's new manufacturing site in Sweden.
France-based Valneva SE's strategy is rooted in its vision of contributing to a world where no one dies or suffers from a vaccine-preventable disease. Dukoral initially produced the SBL vaccine.
DUKORAL Cholera Vaccine Indication
The U.S. CDC recommends vaccination for people traveling to or living in areas of active cholera transmission. In addition, active immunization against disease caused by Vibrio cholerae serogroup O1 is recommended for adults and children (2 years and older) who will be visiting endemic/epidemic areas. But cholera vaccines are not 100% effective. Check the CDC's Travel Health Notices to identify areas with active cholera transmission.
DUKORAL Cholera Vaccine Dosage
DUKORAL is administered orally with a buffer solution that requires 150 ml of clean water for adults. The standard primary course for adults and children over six years old consists of two doses; children under six years old should receive three doses. Doses are to be administered at intervals of at least one week but less than six weeks apart. The primary immunization course should be restarted if more than six weeks have elapsed since the last dose. Immunization should be completed at least one week before potential exposure to Vibrio cholerae O1.
Each dose of DUKORAL vaccine suspension (3ml) contains a total of 1.25 x 1011 bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25 x 109 bacteria, Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x 109 bacteria—recombinant cholera toxin B subunit (rCTB) 1mg.
DUKORAL Vaccine Production
Valneva's global manufacturing network comprises three in-house operations, covering both internal and external production of clinical and commercial products. Valneva's U.S. FDA-approved manufacturing site in Livingston, located just outside Edinburgh, is currently dedicated to producing drug substances for our viral vaccines. Valneva's manufacturing site in Solna is just outside of Stockholm. The site has a long history of vaccine manufacturing and is affiliated with Sweden's state-owned vaccine institute. Valneva's new manufacturing site in Sweden underwent regulatory evaluation and approval in 2024. Along with Valneva's development center in Vienna (Austria), the Company operates GMP laboratories and facilities for the testing and quality control of Valneva's commercial and clinical-stage vaccines.
DUKORAL Cholera Vaccine Warnings and Precautions
DUKORAL® confers protection specific to Vibrio cholerae serogroup O1. Immunization does not protect against V. cholerae serogroup O139 or other species of Vibrio. Administration of DUKORAL® should be postponed for subjects suffering from acute gastrointestinal or febrile illness. DUKORAL is not recommended for use in children under two years of age. Formaldehyde is used during manufacturing, and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. DUKORAL contains approximately 1.1 g of sodium per dose, which patients should consider when following a controlled sodium diet. The vaccine does not provide complete protection against the disease.
Cholera Outbreaks
Various countries have reported cholera outbreaks in 2025.
DUKORAL Vaccine News
August 12, 2025 - In the first half of 2025, DUKORAL® sales were €17.4 million compared to €14.9 million in the first half of 2024. The supply of doses notably contributed to this 16.4% growth, supporting efforts to combat an outbreak on the French island of Mayotte, for a total of €1.1 million in the first quarter of 2025.
May 7, 2025 - Valneva SE reported that in the first quarter of 2025, DUKORAL sales increased 9.4% to €12.3 million, primarily driven by the supply of doses to the French Department of Mayotte.
December 18, 2024—The WHO reported that Oral Cholera vaccine production reached its highest level in November since 2013. This increase allowed the average stock to rise to 3.5 million doses in November, compared to 600,000 in October 2024.
March 20, 2024 - The Company confirmed that DUKORAL® vaccine sales benefited from the significant recovery in the private travel markets.
September 30, 2022 - Cholera Vaccine: Recommendations of the U.S. CDC Advisory Committee on Immunization Practices.
DUKORAL Clinical Studies
In September 2023, a Research Article focused on cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries.
Challenge studies in human volunteers provided the first demonstration of efficacy. The challenge study at the University of Maryland enrolled healthy participants aged 19 to 35. Participants receiving either WC-BS (with 5 mg of CTB) or WC were given three doses at 2-week intervals. In addition, Cimetidine was administered three hours before receiving the vaccine, along with the sodium bicarbonate solution mixed with the vaccine. Vaccinated participants and unvaccinated controls were challenged with 2 × 106 El Tor Inaba V. cholerae (strain N16961) four weeks after completion of the third dose of WC (n = 9) and five weeks after completion of WC-BS (n = 11). The vaccine efficacy of WC was found to be 56%, and for WC-BS, 64% (Table 2). Vaccinated participants in both groups who developed cholera had less severe illness than controls and complete protection from severe diarrhea.
The EMA states that the Company presented data from the published literature and the results of three central studies involving nearly 113,000 people to support the use of Dukoral. In all three studies, Dukoral, given in either two or three doses, was compared with a placebo (a dummy vaccine). The studies took place in areas where cholera was found. The primary measure of effectiveness was the 'protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and a placebo.
The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with a placebo. In this study, Dukoral was formulated using the cholera toxin extracted from cholera bacteria, rather than the newer recombinant toxin. The protective effectiveness of Dukoral was 85% over a six-month period. Protection lasted for six months in children and two years in adults. In adults, two doses of the vaccine were as effective as 3.
The other two studies compared Dukoral (containing recombinant cholera toxin) with a placebo in over 22,000 people in Peru. In the first of two doses, Dukoral's protective effectiveness was 85% for the first five months after vaccination. The people in the second study also received a booster dose 10 to 12 months later. The protective effectiveness of Dukoral after the booster dose was 61% during the second year of follow-up.
