Status:
COMPLETED
Safety of An Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
Eligibility:
All Genders
16-60 years
Phase:
PHASE1
Brief Summary
Cholera is an acute enteric infectious disease caused by the bacterium Vibrio cholera, leading to watery diarrhea and loss of fluids from the small intestines. The World Health Organization (WHO) esti...
Detailed Description
Cholera is an acute enteric infectious disease caused by the bacterium Vibrio cholera, leading to watery diarrhea and loss of fluids from the small intestines. The disease can quickly lead to severe d...
Eligibility Criteria
Inclusion
- \- Healthy adults aged 16-60 years old as established by medical history and clinical examination.
- The subjects' guardians are able to understand and sign the informed consent.
- Subjects who can and will comply with the requirements of the protocol.
- Hemoglobin: 110-150g/L (female), 120-160g/L (male)
- Leukocyte count: 4.0-10.0×109 /L
- Lymphocyte count: 0.8-4.5×109 /L
- Platelet count: 100-300×109/L
- Alanine aminotransferase: (ALT)0-40U/L
- Serum creatinine: 44-106μmol/L
- Subjects with temperature ≤37.0°C on axillary setting.
Exclusion
- Pregnant or lactating women;
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine.
- Have serious side effects to vaccine, such as allergies, hives, breathing difficulties, angioneurotic oedema or abdominal pain;
- abdominal pain or diarrhea;
- asthma, in the past two years, unsteady and require emergency treatment, hospitalization, intubation, oral administration or intravenous corticosteroids;
- Diabetes (type I or II), not including gestational diabetes;
- Thyroid disease
- Serious angioneurotic edema in the past three years, or in need of treatment in the past 2 years
- Hypertension, over 145/95 mmHg
- Blood coagulation disorder (such as the lack of clotting factors, clotting hemorrhagic disease, abnormal platelet) or apparent bruises or blood coagulation disorder
- Malignant tumor, activity or have been treated tumor without cure or may relapse during the test;
- Epilepsy, not including fever epilepsy under 2 years old or alcoholic epilepsy in the first 3 years after temperance or idiopathic epilepsy in the past three years and do not need treatment;
- No spleen, functional asplenia, and any situation caused by no spleen or splenectomy;
- Guillain-Barre syndrome
- Pregnancy test positive women
- Any prior administration of immunodepressant or corticosteroids, and antianaphylactic treatment, cytotoxic therapy in last 6 months.
- Any prior administration of blood products in last 3 month.
- Any prior administration of other research medicines in last 1 month.
- Any prior administration of attenuated live vaccine in last 1 month.
- Any prior administration of subunit or inactivated vaccines in last 2 weeks.
- Had fever before vaccination, subjects with temperature \>37.0°C on axillary setting.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
- Exclusion Criteria for the second and third dose:
- Subject who must be excluded according to the exclusion criteria for the last dose
- Any serious adverse events caused by vaccination.
- Adverse reactions no less than grade 3 within 72 hours after the last vaccination .
Key Trial Info
Start Date :
March 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03237663
Start Date
March 30 2015
End Date
June 23 2017
Last Update
August 2 2017
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