NCT01524640

Brief Summary

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 4, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

January 31, 2012

Last Update Submit

May 1, 2015

Conditions

Vibrio CholeraeCholera

Keywords

oral cholera vaccinesafety and immunogenicitybridging studyethiopia

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects given investigational product with adverse events.

    1. Immediate reactions within 30 minutes after each dose 2. Serious Adverse Events occurring 14 days following each dose 3. Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC

    6 months

  • Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.

    6 months

Secondary Outcomes (3)

  • Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.

    6 months

  • Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.

    6 months

  • Severe adverse event within 28 days following each dose of investigational product.

    6 months

Study Arms (2)

Killed oral cholera vaccine

EXPERIMENTAL

Killed Bivalent (O1 and O139) Whole cell oral cholera vaccine (Shanchol TM) Vaccine strain Reformulated version V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) of lipopolysaccharide (LPS) V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

Biological: Killed Bivalent (O1 and O139) whole cell oral cholera vaccine

Placebo

PLACEBO COMPARATOR

Non biologic placebo Ingredients Per 1.5 ml dose 1. Starch 60mg 2. Red color\[1mg/ml\] 10 µl 3. Yellow color \[1mg/ml\] 5 µl 4. Xanthum Gum (1% solution) 300 µl 5. Water for Injection Upto 1.5 ml All the above ingredients are of pharmaceutical grade. Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization.

Biological: Placebo

Interventions

Killed Bivalent (O1 and O139) whole cell oral cholera vaccineBIOLOGICAL

1.5 ml single dose oral administration on day 0 and day 14

Also known as: Shanchol TM
Killed oral cholera vaccine
PlaceboBIOLOGICAL

1.5 ml oral administration on day 0 and day 14

Also known as: Non biologic placebo
Placebo

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.
  • The subject should be able to continue in the study for the next 4 weeks
  • The subject (or parent/guardian) should be willing to provide 3 blood samples
  • For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
  • Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
  • Healthy subjects as determined by:
  • Medical history
  • Physical examination
  • Clinical judgment of the investigator

You may not qualify if:

  • Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
  • Ongoing acute illness.
  • For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
  • Immunocompromising condition or on chronic systemic steroid therapy
  • Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
  • Intake of any anti-diarrhea medicine in the past week
  • Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
  • Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
  • Previous hypersensitivity to formaldehyde.
  • Receipt of immunoglobulin or any blood product during the past 3 months
  • Receipt of oral cholera vaccine in the past three years
  • Any potential subject currently participating or who will participate within the next six months in another clinical trial
  • Positive screening urine pregnancy test for females greater than 12 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armauer Hansen Research Institute

Addis Ababa, Oromiya, Ethiopia

Location

Related Publications (1)

  • Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, Mesganaw C, Taye H, Beyene D, Bedru A, Singh AP, Wierzba TF, Aseffa A. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527-533. doi: 10.4269/ajtmh.14-0683. Epub 2015 Jun 15.

    PMID: 26078323DERIVED

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 4, 2015

Record last verified: 2015-05

Locations

ET(1)