Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine

NCT02823899 | Completed Phase 1 DMC

• 1 other identifier: PR-16021
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality in low income countries like Bangladesh. In our country, Cholera disease burden consists of both cholera outbreaks and endemic cholera comprising at least 300,000 severe cases and 1.2 million infections each year. To combat this situation, Vaccination against cholera has been proved effective both in endemic and epidemic settings. But, the WHO recommended Dukoral and Prequalified Shanchol are quite expensive for our country perspective. Therefore, locally manufactured OCV can improve the cost effectiveness and make it affordable for all. The hypothesis of this proposal is that Locally produced orally administered whole cell inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children in Bangladesh as compared to ShancholTM. The results of the study will allow us to understand the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. The total sample size will be 840 healthy participants. 840 healthy participants (360 adults, 240 Children and Adolescent and 240 young children) of 18-45 years, 5- less than 18 years and 1 year to less than 5 years will be enrolled in the study. Children whose parents/guardians give voluntary consent will be enrolled in the study. The investigators will provide 2 dose of vaccine for three groups in 14 days interval. Test formulations will be locally manufactured and the comparator group will get Shanchol. The Investigators propose to collect three blood samples (Day 0, 14 and 28).

Conditions

Cholera

Keywords

cholera vaccine; hikojima serotype; randomized trial; immunogenicity

Outcome Measures

Primary Outcomes (3)

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

  Number of participants having reactogenicity 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 participant having 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 personnel.

  Within 14 days after administration of vaccine.

Secondary Outcomes (2)

• Number of participant showing seroconversion of vibriocidal antibody against serogroup O1 Inaba

  14 days after administration of vaccine

• Number of participant showing seroconversion of vibriocidal antibody against serogroup O1 Ogawa.

  14 days after administration of vaccine

Study Arms (2)

HL-OCV

EXPERIMENTAL

Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.

Biological: HL-OCV

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. This vaccine is used as two dose regimen.

Biological: Shanchol

Interventions

HL-OCV BIOLOGICAL

Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.

HL-OCV

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. 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: 1years to less than 5 years for the younger children group; 5- less than18 years for older children and adolescent group and 18- 45 years (inclusive) for the adult group.
• Sex: Male, Female, Transgender.
• Consent: Informed consent from study participants and guardian in case of children along with assent in children 11-17 years (inclusive) of age.
• Apparently healthy.

You may not qualify if:

• Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months
• History of taking oral cholera vaccine.
• 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.
• Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
• Currently on antimicrobial therapy (taking antibiotics within 24 hours during screening and vaccination).
• Severe malnutrition defined as wt-for-ht z-score \<-3.0 with or without oedema.
• For married females pregnancy or plans to become pregnant during the study period (as determined by verbal screening) will be excluded. In addition, pregnancy test will be done by pregnancy strip test before each day of vaccination (Day 0 and day 14) for married female.
• Culture positive V. cholerae, ETEC, Salmonella and Shigella in stool.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.: collaborator

Study Sites (1)

International Centre for Diarrhoeal disease Research,Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (4)

• 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

• Schwartz BS, Harris JB, Khan AI, Larocque RC, Sack DA, Malek MA, Faruque AS, Qadri F, Calderwood SB, Luby SP, Ryan ET. Diarrheal epidemics in Dhaka, Bangladesh, during three consecutive floods: 1988, 1998, and 2004. Am J Trop Med Hyg. 2006 Jun;74(6):1067-73.

  PMID: 16760521 RESULT

• Harris JB, LaRocque RC, Chowdhury F, Khan AI, Logvinenko T, Faruque AS, Ryan ET, Qadri F, Calderwood SB. Susceptibility to Vibrio cholerae infection in a cohort of household contacts of patients with cholera in Bangladesh. PLoS Negl Trop Dis. 2008 Apr 9;2(4):e221. doi: 10.1371/journal.pntd.0000221.

  PMID: 18398491 RESULT

• Chowdhury F, Ali Syed K, Akter A, Rahman Bhuiyan T, Tauheed I, Khaton F, Biswas R, Ferdous J, Al Banna H, Ross AG, Mc Millan N, Sharma T, Kanchan V, Pal Singh A, Gill D, Lebens M, Nordqvist S, Holmgren J, Clemens JD, Qadri F. A phase I/II study to evaluate safety, tolerability and immunogenicity of Hillchol(R), an inactivated single Hikojima strain based oral cholera vaccine, in a sequentially age descending population in Bangladesh. Vaccine. 2021 Jul 22;39(32):4450-4457. doi: 10.1016/j.vaccine.2021.06.069. Epub 2021 Jul 1.

  PMID: 34218960 DERIVED

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 Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 2, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)