Adverse Reaction to Cholera VaccinePhase 2NCT03719066
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
A Phase 2 study testing killed whole cell oral cholera vaccine in people with Adverse Reaction to Cholera Vaccine and Cholera Vaccination Reaction, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Cameroon.
Trial summary
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months following the first dose of vaccine. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction
- What is being tested?
- killed whole cell oral cholera vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteCameroon
- Study dates
- 23 Oct 2018to 5 Oct 2021
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥1 year, stratified into different age groups
- Living in the Soboum Health Area or adjoining area
- Good health condition, without clinically significant medical history (by participant or guardian, in case of minor)
- Not pregnant for female subjects.
- Available to participate for the study duration, including all planned follow-up visits for up to 18 months from screening.
- Signed informed consent -
Who cannot join
- Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function , such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
- Ever having received oral cholera vaccine.
- Receipt of an investigational product (within 30 days before vaccination).
- History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours).
- History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
- Current use of laxatives, antacids, or other agents to lower stomach acidity?
- Planning to become pregnant in the next 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks, 6 months, or 11 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine. The hypothesis is that the vibriocidal GMT following the second dose, when given after 6 or 12 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.
Read the detailed description
This is an open label, randomized, phase 2 clinical trial of the immunogenicity of killed oral cholera vaccine (OCV) when the vaccine is administered to participants of three age cohorts (1-4 years, 5-14 years, and >14 years) and in three dose interval groups (DIGs). The subjects in each age cohort will be randomized to a DIG of 2 weeks (DIG-1), 6 months (DIG-2) or 11 months (DIG-3). A total of 180 subjects from Douala, Cameroon will be enrolled and these are equally divided between the different groups (20 per age/dose interval group). The OCV to be used in the trial is Shanchol.
Blood samples will be collected before the first dose and at intervals following the first dose depending on the dosing interval group assigned. The serum (or plasma) will be tested for antibodies to cholera.
- Being tested
- killed whole cell oral cholera vaccine
- Keywords
- cholera, oral cholera vaccine, vibriocidal titer, ELISA antibodies, Adverse event following immunization
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
killed whole cell oral cholera vaccineBiological
Also called Shanchol
two week interval
| Study group | Role | What they receive |
|---|---|---|
| DIG 1 (dose interval group) | Active comparator | This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered two weeks after the first dose. Receives: Biological: killed whole cell oral cholera vaccine |
| DIG 2 (dose interval group) | Experimental | This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose. Receives: Biological: killed whole cell oral cholera vaccine |
| DIG 3 (dose interval group) | Experimental | This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose. Receives: Biological: killed whole cell oral cholera vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibriocidal titer
Geometric Mean titre of the vibriocidal titre
Measured: two weeks after the second dose
Secondary outcomes (1)
ELISA titres
IgG and IgA geometric mean titres against V cholerae LPS
Measured: two weeks after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start23 Oct 2018
- Primary completion27 Feb 2020
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to Cholera VaccineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive two doses of Shanchol oral cholera vaccine with dose intervals of either 2 weeks, 6 months or 11 months.
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Meilleur Accès aux Soins de Santé (M.A. Santé)
- Responsible party
- Sponsor
- Investigators
- David Sack, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719066
- Sponsor's protocol ID
- 8114
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2018
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will publish the results of this study in a peer reviewed publication and will make the data available on request after the paper has been published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine in Cameroon
- ClinicalTrials.gov ID
- NCT03719066
- Acronym / sponsor ID
- 8114
- Keywords
- cholera, oral cholera vaccine, vibriocidal titer, ELISA antibodies, Adverse event following immunization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Meilleur Accès aux Soins de Santé (M.A. Santé)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 25 Oct 2018 (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.
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks, 6 months, or 11 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks, 6 months, or 11 months following the first dose of vaccine. The hypothesis is that the vibriocidal GMT following the second dose, when given after 6 or 12 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.
Detailed description
This is an open label, randomized, phase 2 clinical trial of the immunogenicity of killed oral cholera vaccine (OCV) when the vaccine is administered to participants of three age cohorts (1-4 years, 5-14 years, and >14 years) and in three dose interval groups (DIGs). The subjects in each age cohort will be randomized to a DIG of 2 weeks (DIG-1), 6 months (DIG-2) or 11 months (DIG-3). A total of 180 subjects from Douala, Cameroon will be enrolled and these are equally divided between the different groups (20 per age/dose interval group). The OCV to be used in the trial is Shanchol.
Blood samples will be collected before the first dose and at intervals following the first dose depending on the dosing interval group assigned. The serum (or plasma) will be tested for antibodies to cholera.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be randomized to receive two doses of Shanchol oral cholera vaccine with dose intervals of either 2 weeks, 6 months or 11 months.
| Arm | Type | Receives |
|---|---|---|
| DIG 1 (dose interval group) | Active comparator | Biological: killed whole cell oral cholera vaccineThis group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered two weeks after the first dose. |
| DIG 2 (dose interval group) | Experimental | Biological: killed whole cell oral cholera vaccineThis group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose. |
| DIG 3 (dose interval group) | Experimental | Biological: killed whole cell oral cholera vaccineThis group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥1 year, stratified into different age groups
- Living in the Soboum Health Area or adjoining area
- Good health condition, without clinically significant medical history (by participant or guardian, in case of minor)
- Not pregnant for female subjects.
- Available to participate for the study duration, including all planned follow-up visits for up to 18 months from screening.
Key exclusion criteria (7 listed)
- Presence of a significant medical or psychiatric condition (Examples include: Diagnosis and treatment of tuberculosis (TB) or HIV; renal insufficiency; hepatic disease; oral or parenteral medication known to affect the immune function , such as corticosteroids, other immunosuppressant drugs; or behavioural or memory issues)
- Ever having received oral cholera vaccine.
- Receipt of an investigational product (within 30 days before vaccination).
- History of diarrhoea in 7 days prior to first dose of vaccine (defined as ≥3 unformed loose stools in 24 hours).
- History of chronic diarrhea (lasting for more than 2 weeks in the past 6 months)
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 |
|---|---|---|
| killed whole cell oral cholera vaccineAlso: Shancholtwo week interval | Biological | DIG 1 (dose interval group), DIG 2 (dose interval group), DIG 3 (dose interval group) |
Primary outcome
Vibriocidal titer
Time frame: two weeks after the second dose
Geometric Mean titre of the vibriocidal titre
1 secondary outcome
ELISA titres
Time frame: two weeks after the second 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 5 Oct 2022.
- Individual participant dataSharing planned: Yes. We will publish the results of this study in a peer reviewed publication and will make the data available on request after the paper has been published.
Related trials for Adverse Reaction to Cholera Vaccine
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
Not yet recruitingPhase 1
Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants
Cholera Vaccination Reaction
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.
David Sack, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing killed whole cell oral cholera vaccine in people with Adverse Reaction to Cholera Vaccine and Cholera Vaccination Reaction, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Cameroon.
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 6 inclusion and 7 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Vibriocidal titer (time frame: two weeks after the second 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 5 Oct 2022.