recombinant cholera toxin b subunit + vibrio cholerae: clinical use

Prescribing considerations

• Base use on destination epidemiology, outbreak status, itinerary, access to safe water and medical care, and official recommendations.
• It protects specifically against V. cholerae O1 and must supplement, not replace, food, water and hygiene precautions.
• Postpone administration during acute gastrointestinal or febrile illness.
• Consider potentially reduced immune response in advanced HIV disease or other endogenous or treatment-related immunosuppression.
• Protective-efficacy evidence is very limited in people aged 65 years and over.
• Account for the product’s substantial sodium content in patients following a controlled-sodium diet.

Contraindications and cautions

• Hypersensitivity to the active substances, any excipient or formaldehyde.
• The product is not recommended below 2 years because protective efficacy has not been established.

Monitoring

• Record the product name and batch number to maintain biological-product traceability.
• Assess allergy history, current febrile or gastrointestinal illness, immune status and relevant dietary sodium restriction before administration.
• Reinforce prompt rehydration and medical assessment if significant diarrhoea occurs despite vaccination.

Clinical pharmacology

The vaccine combines killed V. cholerae O1 strains representing Inaba and Ogawa serotypes and El Tor and classical biotypes with recombinant non-toxic cholera toxin B subunit. It acts locally by inducing antibacterial and antitoxin intestinal antibodies; pharmacokinetic assessment is not applicable.

Formulation and product differences

• Supplied as a whitish oral vaccine suspension in a vial plus raspberry-flavoured effervescent buffer powder in a sachet.
• The buffer must be dissolved in cool water before the vaccine suspension is added; it protects the antigens against gastric acid.
• The prepared mixture should be used within 2 hours.
• Store refrigerated, do not freeze, and follow the SmPC if storage outside refrigeration has occurred.