NCT02027207: SCVB

Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh

Completed Phase 3 Last updated 20 March 2018

What this trial tests

Phase 3 trial testing Shanchol in Cholera in 204,438 participants. Completed in 31 December 2017.

Timeline

9 December 2012

Primary endpoint
1 December 2017

31 December 2017

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	204,438
Start date	9 December 2012
Primary completion	1 December 2017
Estimated completion	31 December 2017
Sites	1 location across Bangladesh

Drugs / interventions tested

• Shanchol — full drug profile →
• Placebo

Conditions studied

• Cholera — all drugs for Cholera →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

1 and older, any sex, with Cholera. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy.

The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh.
   Qadri F, Wierzba TF, Ali M, Chowdhury F, et al · · 2016 · cited 130× · PMID 27144848 · DOI 10.1056/nejmoa1510330
2. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial.
   Qadri F, Ali M, Lynch J, Chowdhury F, et al · · 2018 · cited 61× · PMID 29550406 · DOI 10.1016/s1473-3099(18)30108-7
3. Augmented immune responses to a booster dose of oral cholera vaccine in Bangladeshi children less than 5 years of age: Revaccination after an interval of over three years of primary vaccination with a single dose of vaccine.
   Chowdhury F, Bhuiyan TR, Akter A, Bhuiyan MS, et al · · 2020 · cited 10× · PMID 31879124 · DOI 10.1016/j.vaccine.2019.12.034
4. Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial.
   Khan AI, Ali M, Lynch J, Kabir A, et al · · 2019 · cited 7× · PMID 31092224 · DOI 10.1186/s12879-019-4006-3