A Phase 2 interventional study of killed whole cell oral cholera vaccine in Adverse Reaction to Cholera Vaccine and Cholera Vaccination Reaction, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Cameroon. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Prevention
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.
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.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 181 is below the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered two weeks after the first dose.
Biological: killed whole cell oral cholera vaccine
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 6 months after the first dose.
Biological: killed whole cell oral cholera vaccine
This group will receive two doses of killed whole cell oral cholera vaccine. The second dose being administered 11 months after the first dose.
Biological: killed whole cell oral cholera vaccine
two week interval
Also known as: Shanchol
Vibriocidal titer
Geometric Mean titre of the vibriocidal titre
Time frame: two weeks after the second dose
ELISA titres
IgG and IgA geometric mean titres against V cholerae LPS
Time frame: two weeks after the second dose
Plan to share: 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.
Supporting information: Clinical study report
Time frame: When the manuscript is published.
Access criteria: Researchers will need to submit a request to the investigators detailing their plans for analysis.
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Feb 2020, 16 months.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Shanchol
Johns Hopkins Bloomberg School of Public Health →