Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)Phase 1NCT03237663
Safety of An Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
A Phase 1 study testing The oral O1 / O139 cholera vaccine (enteric capsules) in people with Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules), run by Jiangsu Province Centers for Disease Control and Prevention.
Trial 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) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
- What is being tested?
- The oral O1 / O139 cholera vaccine (enteric capsules)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2015to 23 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- - 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
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- 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.
Who cannot join
- 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;
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- 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.
- 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 .
About this study
Official title: Safety of An Oral O1 / O139 Cholera Vaccine (Enteric Capsules) Through Phase I Clinical Trial in China
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) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. Cholera is mainly caused by the O1 or O139 serogroups of V. cholera. Vaccination has been shown to be a cost-effective, more immediate option for cholera control and prevention. Injectable vaccine is not recommended by the World Health Organization (WHO) mainly because of its limited efficacy and short duration of protection. However, the inactivated whole-cell, bivalent O1 and O139 cholera vaccine have provided evidence of substantial protective efficacy. With the goal of making an ideal low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules).
Read the 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 dehydration and death without proper and timely management. The World Health Organization (WHO) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. The high morbidity and consequent mortality caused by cholera is attributable to several factors, including lack of access to safe drinking water, poor sanitation and poor hygiene practices and transmitted via the fecal-oral route by ingesting food or water contaminated with the bacterium. Cholera is a significant public health issue in many developing countries in Africa, Southeast Asia, the Caribbean, and South America, and is rare in industrial countries with most cases occurring in travelers who have visited cholera-affected areas.
Cholera is mainly caused by the O1 or O139 serogroups of V. cholerae among the more than 200 V. cholerae serogroups, O1 strains are divided into two biotypes: Classical and El Tor. Each biotype can be further divided into 3 serotypes: Inaba, Ogawa, Hikojima. V. cholerae O1 has been shown to be responsible for the first six cholera pandemics. In 1992, a new V. cholerae serogroup O139 emerged and it has caused epidemics that spanned most of Asia. This strain was a genetic derivative of El Tor biotype in which the O1 biosynthetic genes were replaced by the O139 biosynthetic genes. Both V. cholerae O1 and O139 can produce an enterotoxin, which causes serious diarrhea, causing dehydration, and can lead to death in a few days.
Vaccination has been shown to be a cost-effective, more immediate option for cholera control and prevention. Injectable vaccine is not recommended by the World Health Organization (WHO) mainly because of its limited efficacy less than 50% and short duration of protection almost no more than six months. Enteric vaccination has already been regarded as the most effective approach to control such illnesses as well as to prevent cholera in endemic countries. The inactivated whole-cell, bivalent O1 and O139 cholera vaccine have provided evidence of substantial protective efficacy up to 60% at least 3-5 years. In 2011 the first low-cost oral cholera vaccine for international use was given prequalification by the World Health Organization (WHO). With the goal of making an ideal low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules), in order to fulfill the requirements of WHO. On the other hand, China is a non-endemic country of cholera, it will also can provided a safe and convenient vaccine for the travellers who visited cholera-affected areas.
- Being tested
- The oral O1 / O139 cholera vaccine (enteric capsules)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The oral O1 / O139 cholera vaccine (enteric capsules)Biological
| Study group | Role | What they receive |
|---|---|---|
| One enteric capsule | Experimental | Not described Receives: Biological: The oral O1 / O139 cholera vaccine (enteric capsules) |
| Two enteric capsule | Experimental | Not described Receives: Biological: The oral O1 / O139 cholera vaccine (enteric capsules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects reporting solicited adverse reactions.
Proportion of subjects reporting adverse reactions on day 7 post-each dose.
Measured: Day 7 post-each dose
Secondary outcomes (1)
Proportion of subjects reporting unsolicited adverse events.
Proportion of subjects reporting unsolicited adverse events on day 28 post-each dose.
Measured: Day 28 post-each dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start30 Mar 2015
- Primary completion5 Nov 2016
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237663
- Sponsor's protocol ID
- JSVCT023
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of An Oral O1 / O139 Cholera Vaccine (Enteric Capsules) Through Phase I Clinical Trial in China
- ClinicalTrials.gov ID
- NCT03237663
- Acronym / sponsor ID
- JSVCT023
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. Cholera is mainly caused by the O1 or O139 serogroups of V. cholera. Vaccination has been shown to be a cost-effective, more immediate option for cholera control and prevention. Injectable vaccine is not recommended by the World Health Organization (WHO) mainly because of its limited efficacy and short duration of protection. However, the inactivated whole-cell, bivalent O1 and O139 cholera vaccine have provided evidence of substantial protective efficacy. With the goal of making an ideal low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules).
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 dehydration and death without proper and timely management. The World Health Organization (WHO) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. The high morbidity and consequent mortality caused by cholera is attributable to several factors, including lack of access to safe drinking water, poor sanitation and poor hygiene practices and transmitted via the fecal-oral route by ingesting food or water contaminated with the bacterium. Cholera is a significant public health issue in many developing countries in Africa, Southeast Asia, the Caribbean, and South America, and is rare in industrial countries with most cases occurring in travelers who have visited cholera-affected areas.
Cholera is mainly caused by the O1 or O139 serogroups of V. cholerae among the more than 200 V. cholerae serogroups, O1 strains are divided into two biotypes: Classical and El Tor. Each biotype can be further divided into 3 serotypes: Inaba, Ogawa, Hikojima. V. cholerae O1 has been shown to be responsible for the first six cholera pandemics. In 1992, a new V. cholerae serogroup O139 emerged and it has caused epidemics that spanned most of Asia. This strain was a genetic derivative of El Tor biotype in which the O1 biosynthetic genes were replaced by the O139 biosynthetic genes. Both V. cholerae O1 and O139 can produce an enterotoxin, which causes serious diarrhea, causing dehydration, and can lead to death in a few days.
Vaccination has been shown to be a cost-effective, more immediate option for cholera control and prevention. Injectable vaccine is not recommended by the World Health Organization (WHO) mainly because of its limited efficacy less than 50% and short duration of protection almost no more than six months. Enteric vaccination has already been regarded as the most effective approach to control such illnesses as well as to prevent cholera in endemic countries. The inactivated whole-cell, bivalent O1 and O139 cholera vaccine have provided evidence of substantial protective efficacy up to 60% at least 3-5 years. In 2011 the first low-cost oral cholera vaccine for international use was given prequalification by the World Health Organization (WHO). With the goal of making an ideal low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules), in order to fulfill the requirements of WHO. On the other hand, China is a non-endemic country of cholera, it will also can provided a safe and convenient vaccine for the travellers who visited cholera-affected areas.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One enteric capsule | Experimental | Biological: The oral O1 / O139 cholera vaccine (enteric capsules) |
| Two enteric capsule | Experimental | Biological: The oral O1 / O139 cholera vaccine (enteric capsules) |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- - 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
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The oral O1 / O139 cholera vaccine (enteric capsules) | Biological | One enteric capsule, Two enteric capsule |
Primary outcome
Proportion of subjects reporting solicited adverse reactions.
Time frame: Day 7 post-each dose
Proportion of subjects reporting adverse reactions on day 7 post-each dose.
1 secondary outcome
Proportion of subjects reporting unsolicited adverse events.
Time frame: Day 28 post-each dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The oral O1 / O139 cholera vaccine (enteric capsules) in people with Safety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules), run by Jiangsu Province Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects reporting solicited adverse reactions. (time frame: Day 7 post-each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.