Vibrio cholerae live attenuated: clinical use

Prescribing considerations

• Base use on destination-specific exposure risk; vaccination does not replace food, water and hygiene precautions.
• Postpone during acute gastroenteritis because the immune response may be reduced.
• Protection may be reduced in people with HIV; effects in chronic gastrointestinal disease are unknown.
• Assess antibiotic use, chloroquine prophylaxis and oral Ty21a vaccination.
• Counsel about possible stool shedding and careful hand hygiene, particularly around vulnerable household contacts.
• Clinical efficacy and immunogenicity data are unavailable in people older than 64 years.

Contraindications and cautions

• Hypersensitivity to the active substance or any excipient.
• Congenital immune deficiency or current immunosuppressive treatment.
• Rare hereditary galactose intolerance, total lactase deficiency, glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase insufficiency, as applicable to the excipients.

Monitoring

• Record the product name and batch number for traceability.
• Verify immune status, gastrointestinal illness, relevant interactions and successful consumption of the prepared suspension. No routine laboratory monitoring is specified.
• Advise reporting suspected adverse reactions through the MHRA Yellow Card scheme.

Clinical pharmacology

A live attenuated recombinant CVD 103-HgR strain of Vibrio cholerae O1 classical Inaba replicates in the gastrointestinal tract and induces serum vibriocidal antibody and memory B-cell responses. Pharmacokinetic assessment is not applicable.

Formulation and product differences

• Separate buffer and active-ingredient powder sachets must be mixed in the correct order to form an oral suspension.
• The preparation contains lactose, sucrose and a clinically relevant sodium load.
• It contains genetically modified organisms and requires refrigerated storage, protection from light and moisture, and appropriate biosafety disposal.
• Preparation includes an age-specific buffer step for children aged 2 to under 6 years.