Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine

NCT02742558 | Completed Phase 2 DMC

• 1 other identifier: PR-15076
• Study Type: interventional
• Target: 2,052
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks. Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).

Conditions

Cholera

Keywords

cholera vaccine; randomized trial; immunogenicity

Outcome Measures

Primary Outcomes (4)

• Number of participants with vaccine related reactogenicity as assessed by study personnel

  Number of reactogenecity events will be compared between test group and comparator group.

  Within 30 minutes after administration of vaccine

• Number of participants with solicited adverse events as assessed by study personnel

  Number of solicited adverse events observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group

  Within 7 days after administration of vaccine

• Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician

  Number of unsolicited adverse events including serious adverse event observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group

  Within 6 months after administration of vaccine

• Number of participants showing seroconversion against sero group V. cholerae O1

  Proportion of participants showing sero-conversion against V. cholerae O1, upon vaccination Cholvax being tested in comparison with ShancholTM.

  7 days after administration of vaccine

Secondary Outcomes (1)

• Number of participants showing seroconversion against sero group V. cholerae O139

  7 days after administration of vaccine

Study Arms (2)

cholvax

EXPERIMENTAL

Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation.

Biological: Cholvax

shanchol

ACTIVE COMPARATOR

The vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen.

Biological: Shanchol

Interventions

Cholvax BIOLOGICAL

Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation.

cholvax

Shanchol BIOLOGICAL

The vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen.

shanchol

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 1-45 Years.
• Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years.
• Participation in the study at least for next 6 months
• Considered healthy as per medical judgment of the investigator

You may not qualify if:

• Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months
• History of taking oral cholera vaccine and history of confirmed cholera.
• History of taking any other live or killed enteric vaccine in the last 8 weeks.
• History of anaphylaxis or serious vaccine reaction.
• Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing.
• Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
• Currently on antimicrobial therapy. 9.Severe malnutrition or chornic disease based on the jugement of the investigator.
• Stool sample at screening positive for V. cholerae. 11.Pregnant women or plans to become pregnant during the study period .

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• International Vaccine Institute: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (3)

• Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, Clemens J. The global burden of cholera. Bull World Health Organ. 2012 Mar 1;90(3):209-218A. doi: 10.2471/BLT.11.093427. Epub 2012 Jan 24.

  PMID: 22461716 RESULT

• Maskery B, DeRoeck D, Levin A, Kim YE, Wierzba TF, Clemens JD. Strategy, demand, management, and costs of an international cholera vaccine stockpile. J Infect Dis. 2013 Nov 1;208 Suppl 1:S15-22. doi: 10.1093/infdis/jit233.

  PMID: 24101640 RESULT

• Saha A, Chowdhury MI, Khanam F, Bhuiyan MS, Chowdhury F, Khan AI, Khan IA, Clemens J, Ali M, Cravioto A, Qadri F. Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. Vaccine. 2011 Oct 26;29(46):8285-92. doi: 10.1016/j.vaccine.2011.08.108. Epub 2011 Sep 9.

  PMID: 21907255 RESULT

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Firdausi Qadri, Dr.

  International Centre for Diiarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)