Bridging Trial of Bivalent Killed Oral Cholera Vaccine in Ethiopia

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201202000354245
• Date of registration: 01/02/2012
• Primary sponsor: International Vaccine Institute
• Public title: Bridging Trial of Bivalent Killed Oral Cholera Vaccine in Ethiopia
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, CONTROLLED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF KILLED BIVALENT (O1 AND O139) WHOLE-CELL BASED ORAL CHOLERA VACCINE (SHANCHOL?) IN HEALTHY INDIVIDUALS IN ETHIOPIA
• Date of first enrolment: 2012-03-12
• Target sample size: 216
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201202000354245
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Permuted block randomisation (block size 4),; allocation was determined by the holder of the sequence who is situated off site,

Countries of recruitment

South Africa

Contacts

• Name: Jemal Hussein
• Affiliation: Medical Doctor, Clinical Researcher

• Name: Sachin N Desai

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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.
a. The subject should be able to continue
in the study for the next 4 weeks
b. The subject (or parent/guardian)should
be willing to provide 3 blood samples
2. For females of reproductive age, non
pregnant (as determined by urine pregnancy
test).
3.Written informed consent obtained from the
subjects or their parents/guardians, and
written assent obtained from children aged
12 ? 17 years.
4.Healthy subjects as determined by:
a.Medical history
b.Physical examination
c.Clinical judgment of the investigator

Exclusion criteria: 1. Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
2. Ongoing acute illness.
3. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
4. Immunocompromising condition or on chronic systemic steroid therapy
5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
6. Intake of any anti-diarrhea medicine in the past week
7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
8. Temperature ?38?C (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
9. Previous hypersensitivity to formaldehyde.
10. Receipt of immunoglobulin or any blood product during the past 3 months
11. Receipt of oral cholera vaccine in the past three years
12. Any potential subject currently participating or who will participate within the next six months in another clinical trial
13. Positive screening urine pregnancy test for females greater than 12 years of age


Age minimum: 1 Year
Age maximum: 999 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Cholera

Primary Outcome(s)

Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline

Proportion of subjects given investigational product with any of the following adverse events (immediate adverse events, any severe adverse events, reactogenicity)

Secondary Outcome(s)

1. Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline

2. Geometric mean serum vibriocidal titers at baseline

Occurence of any severe adverse event

Source(s) of Monetary Support

LG Electronics