Cholvax

Approved Indications:

• Active immunization against cholera caused by Vibrio cholerae O1 and/or O139 in:
• Individuals ≥1 year in cholera-endemic regions or outbreak zones.
• Travelers to areas with active cholera transmission.
• Refugees, disaster-affected populations, slum dwellers, and healthcare workers in high-risk regions.
• Mass vaccination campaigns in cholera hotspots for epidemic control.

Clinically Accepted Off-label Uses:

• Pre-emptive immunization before seasonal cholera surges.
• Vaccination of high-risk pregnant women (with killed vaccines).
• Immunization of immunocompromised individuals (killed vaccines preferred).

Route: Oral only (do not inject).

Shanchol® / Euvichol-Plus® (Killed Bivalent Whole-Cell Vaccine):

• Ages ≥1 year:
  2 doses (1.5 mL each), 2 weeks apart.
  No buffer or food restrictions required.
  Immunity begins 7–10 days after the second dose and lasts up to 3 years.

Dukoral® (Killed Whole-Cell with Recombinant B Subunit):

• Adults & children ≥6 years:
  2 doses, 1–6 weeks apart.
  Administer each dose mixed with a buffer in 150 mL water.
  Avoid food/drink 1 hour before and after.
  Immunity starts 1 week after the last dose and lasts up to 2 years.
• Children 2–6 years:
  3 doses, each at least 1 week apart.

Vaxchora® (Live Attenuated Vaccine, for Travelers):

• Adults 18–64 years:
  1 single oral dose ≥10 days before travel.
  Take on an empty stomach.
  Provides protection for up to 3 months.

Special Groups:

• Elderly: Same dosing as adults.
• Renal/Hepatic Impairment: No dose adjustment needed.
• Immunocompromised patients: Killed vaccines only; live vaccines contraindicated.
• Pregnancy/Lactation: Killed vaccines like Shanchol® are safe (see Section 5).

Oral cholera vaccines stimulate local mucosal and systemic immunity against Vibrio cholerae O1 and/or O139.
Killed vaccines (e.g., Shanchol®, Dukoral®) contain inactivated bacteria that induce secretory IgA responses in the gut, preventing bacterial adhesion and toxin-mediated diarrhea. Dukoral® also contains recombinant cholera toxin B subunit (rCTB), enhancing protection against cholera toxin.
Live attenuated vaccines (e.g., Vaxchora®) transiently colonize the intestine, triggering robust immune memory and mucosal responses, mimicking natural infection without causing disease.

• Absorption: Not absorbed; acts locally in the gastrointestinal tract.
• Distribution: No systemic distribution.
• Metabolism: Not metabolized; vaccine components are degraded in the GI tract.
• Excretion: Eliminated via feces.
• Onset of Action:
• Shanchol®/Euvichol®: ~7–10 days after second dose
• Dukoral®: ~7 days after final dose
• Vaxchora®: ~10 days post-dose
• Duration of Immunity:
• Shanchol®: ~3 years
• Dukoral®: ~2 years
• Vaxchora®: ~3 months

• Pregnancy:
  No formal FDA category. However, killed vaccines (Shanchol®, Dukoral®) are considered safe during pregnancy, especially during cholera outbreaks.
  Live vaccines (Vaxchora®) are contraindicated in pregnancy.
• Lactation:
  Killed oral cholera vaccines are safe during breastfeeding. No significant excretion into breast milk. Breastfeeding should continue during immunization.

• Primary Class: Oral Vaccine
• Subclass: Inactivated (killed) or live attenuated cholera vaccine

• Known hypersensitivity to vaccine components (e.g., rCTB, formaldehyde, or flavoring agents)
• Acute gastrointestinal illness (e.g., vomiting, diarrhea)
• Severe allergic reaction to previous cholera vaccine dose
• Live vaccine (Vaxchora®) contraindicated in:
• Pregnancy
• Lactation
• Immunocompromised individuals
• Children under 18 years

• Not a replacement for safe water and sanitation.
• Postpone vaccination if the patient is acutely ill or vomiting.
• Avoid food or drink 1 hour before and after Dukoral®.
• Live vaccines should not be given to immunocompromised persons or their close contacts.
• Vaccination provides strain-specific protection; does not cover all diarrhea causes.
• Use only WHO-prequalified vaccines for mass campaigns.

Common:

• Mild gastrointestinal discomfort
• Nausea, vomiting
• Abdominal cramps
• Fatigue
• Headache

Uncommon:

• Low-grade fever
• Mild diarrhea

Rare:

• Hypersensitivity reactions (rash, pruritus)
• Anaphylaxis (extremely rare)

Onset: Most side effects occur within 1–3 days and are self-limiting.

• Antibiotics: Avoid administering oral cholera vaccines within 7 days of antibiotic use (especially with live vaccine).
• Immunosuppressants: May reduce vaccine efficacy. Avoid live vaccines in these patients.
• Food/Drink:
• Dukoral®: Must be taken on an empty stomach with buffer.
• Shanchol®: No food restrictions.
• Enzyme Interactions: No involvement with CYP450 systems.

• WHO (2024): Recommends Shanchol® and Euvichol-Plus® for use in endemic and emergency settings.
• GTFCC Strategy (2023–2030): Cholera control includes 2-dose OCV as part of integrated prevention efforts.
• Bangladesh (2024): Mass vaccination continues using Shanchol® and Euvichol® in high-risk zones (e.g., Rohingya camps, urban slums).
• Vaxchora® (USA only): Approved for travelers aged 18–64 years.

• Shanchol® / Euvichol® / Euvichol-Plus®:
• Store at 2°C to 8°C
• Stable at up to 25°C for short durations
• Do not freeze
• Shake well before use
• Dukoral®:
• Store at 2°C to 8°C
• Requires reconstitution with buffer before administration
• Protect from light and do not freeze
• Vaxchora®:
• Store in refrigerator (2°C to 8°C)
• Use immediately after reconstitution
• Do not freeze