Field Application of Shanchol in Adults in Bangladesh

NCT01762930 | Completed Phase 2 DMC

• 1 other identifier: PR-12030
• Study Type: interventional
• Target: 1,015
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cholera is a public health problem globally and in Bangladesh and its prevention is important. Despite recent availability of an effective and affordable oral cholera vaccine (OCV), its field application remains a challenge and needs to be addressed in carefully conducted research studies.There is lack of information on temperature sensitivity and resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses of OCVs, one month apart, instead of currently recommended 14 days, to improve success of vaccination programme will be effective;also if one dose of the vaccine, instead of currently recommended two doses, would result in adequate immune response in population exposed to V. cholerae in an endemic country like Bangladesh. Objectives: To determine immunogenicity of Shanchol in adults. when:

1. 1.the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days, before putting back in cold box for administration in the field and compare them with the response when the vaccine is stored under currently recommended temperatures.
2. 2.two doses of the vaccine administered one month apart and compared vaccines administered at currently recommended interval of 14 days.
3. 3.a single dose is administered and compare them with responses after recommended two doses.
4. 4.Objective 1: safety and immunogenicity of vaccine in adults after its storage at three defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses and compare them with the findings when the vaccine is stored at currently recommended temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).
5. 5.Objective 2: compare vibriocidal responses following administration of two doses of the vaccine one month apart and compare them with vaccination 14 days apart over a period of one year, with study of the memory responses over a one year period as a secondary outcome.
6. 6.Objective 3: compare acute immune responses (vibriocidal antibody) following one and two doses of vaccine, and compare memory response as a secondary outcome measure, over a one year period.

Conditions

Other Specified Effects of Reduced Temperature

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of Shanchol cholera vaccine

  Immunogenicity of Shanchol vaccine will be measured by vibriocidal response in adults storing the vaccine at 2-8 0 c, 25 oC, 37 oC and 42oC

  1 year

Secondary Outcomes (2)

• Immunogenicity by vibriocidal response

  1 year

• Acute and memory B and T cell responses

  1 year

Study Arms (4)

Shanchol stored at 2-8oC

ACTIVE COMPARATOR

Vaccines will be stored at 2-8oC before administration.

Drug: Shanchol

Shanchol stored at 25oC

EXPERIMENTAL

Vaccines will be stored at 25oC for 14 days before administration.

Drug: Shanchol

Shanchol stored at 37oC

EXPERIMENTAL

Vaccines will be stored at 37oC for 14 days before administration.

Drug: Shanchol

Shanchol stored at 42oC

EXPERIMENTAL

Vaccines will be stored at 42oC for 14 days before administration.

Drug: Shanchol

Interventions

Shanchol DRUG

Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).

Shanchol stored at 2-8oC; Shanchol stored at 25oC; Shanchol stored at 37oC; Shanchol stored at 42oC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy individuals
• Age: 18-45 years
• Sex: Both male and female
• Consent: Written informed consent form for participation in the study

You may not qualify if:

• History of chronic illness, such as TB, hypertension, chronic asthma, diabetes
• Gastrointestinal disorder such as abdominal pain or cramps, loss of appetite, nausea, vomiting or diarrhoea in the past 7 days
• Intake of any anti-diarrheal medicine in the past one week or antimicrobial therapy in the past two weeks.
• Any febrile illness in the past 7 days.
• Receiving killed oral cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
• Immunocompromising condition or receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
• Females of reproductive age who are pregnant at the time of vaccination and follow up (determined by verbal screening e.g last menstrual period (LMP)).

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

International Centre for Diarrhoeal disease Research,Bangladesh

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Related Publications (4)

• Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.

  PMID: 19761838 RESULT

• Alam MM, Riyadh MA, Fatema K, Rahman MA, Akhtar N, Ahmed T, Chowdhury MI, Chowdhury F, Calderwood SB, Harris JB, Ryan ET, Qadri F. Antigen-specific memory B-cell responses in Bangladeshi adults after one- or two-dose oral killed cholera vaccination and comparison with responses in patients with naturally acquired cholera. Clin Vaccine Immunol. 2011 May;18(5):844-50. doi: 10.1128/CVI.00562-10. Epub 2011 Feb 23.

  PMID: 21346055 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

• Saha A, Khan A, Salma U, Jahan N, Bhuiyan TR, Chowdhury F, Khan AI, Khanam F, Muruganandham S, Reddy Kandukuri S, Singh Dhingra M, Clemens JD, Cravioto A, Qadri F. The oral cholera vaccine Shanchol when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants. Vaccine. 2016 Mar 18;34(13):1551-1558. doi: 10.1016/j.vaccine.2016.02.020. Epub 2016 Feb 16.

  PMID: 26896684 DERIVED

MeSH Terms

Interventions

shanchol

Study Officials

• Amit Saha, M.Med

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: January 8, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

BA (1)