Help protect patients where they may want
to go with VAXCHORA

Why VAXCHORA¹?

Indication and Usage

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.

Limitations of Use: The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

The Advisory Committee on Immunization Practices recommends VAXCHORA for adult travelers aged 18 to 64 years who are visiting an area of active cholera transmission. Active transmission is defined as having cases reported within the past year.²

To read the full recommendation and see the most recent updates, visit the CDC website.

Demonstrated Efficacy Profile¹

Study 2

Study Design: VAXCHORA was studied in a randomized, double-blind, saline placebo–controlled V. cholerae challenge study conducted in US subjects 18 through 45 years of age with no prior history of cholera infection or travel to a cholera-endemic area in the previous 5 years. The primary endpoint was the prevention of moderate (≥3.0 L) to severe (≥5.0 L) diarrhea.^3,a,b,c,d

VAXCHORA demonstrated vaccine efficacy in the prevention of moderate to severe diarrhea following challenge with V. cholerae O1 El Tor Inaba at 10 days and 3 months post-vaccination.

The 10-day and 3-month cohorts consisted of different volunteers.

Cohort 1

68 healthy volunteers were randomized to receive VAXCHORA (n=35) or placebo (n=33) in the 10-day challenge¹

Efficacy 10 days after vaccination¹

In the 10-day challenge group, 2 volunteers receiving VAXCHORA (5.7%) developed moderate or severe diarrhea after challenge.¹

Cohort 2

66 healthy volunteers were randomized to receive VAXCHORA (n=33) or placebo (n=33) in the 3-month challenge¹

Efficacy 3 months after vaccination¹

In the 3-month challenge group, 4 volunteers taking VAXCHORA (12.1%) developed moderate or severe diarrhea after challenge.¹

Volunteers who received VAXCHORA were compared with a pooled group of volunteers who received placebo.

The majority of placebo recipients (39/66, 59.1%) developed moderate or severe diarrhea after being challenged with V. cholerae.

The duration of protection following vaccination with VAXCHORA is unknown

• ^a P<0.0001 vs placebo.³
• ^b The duration of shedding of the vaccine strain is unknown.
• ^c Moderate or severe diarrhea defined as ≥3.0 L or ≥5.0 L, respectively, within 10 days after being challenged with V. cholerae 01 El Tor Inaba.³
• ^d Vaccine Efficacy=[(Attack Rate in Placebo Group – Attack Rate in Vaccine Group)/Attack Rate in Placebo Group] x 100.

Study 1

VAXCHORA stimulated an immune response in more than 90% of recipients^4,a

Study Design: Study 1 was a randomized, double-blind, placebo-controlled trial of 3146 volunteers.

Seroconversion occurred in 94% of vaccine recipients versus 4% in placebo recipients 10 days after vaccination⁴

Seroconversion after 10 days

• ^a Seroconversion defined as a ≥4-fold rise in vibriocidal antibody against homologous classical Inaba.⁴
• ^bP<0.0001.⁴

Substudy results⁴

VAXCHORA recipients demonstrated elevated antibody titers through 6 months^a

• In a substudy of 32 participants, cumulative seroconversion occurred in 96% of VAXCHORA recipients by 1 month^a
  
  - Vibriocidal antibody geometric mean titers gradually declined over time but remained elevated through 6 months

• ^a An immune substudy of 32 participants (26 VAXCHORA recipients and 6 placebo recipients) who were selected through a convenience sample and voluntarily enrolled.

Safety Profile¹

The safety of VAXCHORA was evaluated in more than 3000 volunteers aged 18 to 64 years in 4 randomized, placebo-controlled, multicenter clinical trials

In a pooled analysis of adults aged 18 to 64 years, 0.6% (20/3235) of VAXCHORA recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination.

Dosing and Administration¹

VAXCHORA delivers cholera prevention in just 1 dose

How Supplied/Storage and Handling¹

VAXCHORA is supplied as shown below. The contents of both packets are reconstituted with purified bottled or spring bottled water to form one oral dose of the vaccine.

Storage and handling¹

• Store VAXCHORA buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C)
• Protect from light and moisture
• Packets should not be out of refrigerated storage for more than 12 hours prior to reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 80°F (27°C)

For medical inquiries about storage of VAXCHORA, please contact Medical Information at
(800) 533-5899.