CholeraPhase 4NCT03373669
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
A Phase 4 study testing Oral Cholera Vaccine and Adjusted Dose Oral Cholera Vaccine in people with Cholera and Vibrio Cholerae Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
Trial summary
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Cholera, Vibrio Cholerae Infection
- What is being tested?
- Oral Cholera Vaccine and Adjusted Dose 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
- 120 participants
- Where
- 1 siteZambia
- Study dates
- 16 Nov 2017to 1 Dec 2020
- Phase
- Phase 4
- 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 Waya Clinic Catchment 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 9 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
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
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, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 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 or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 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
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
As described in the package insert, the standard dosing schedule of the OCV is two doses with the second dose given 2 weeks after the first. In several campaigns, it was felt to appropriate to give a single dose to twice as many people and to give the second dose at a later time when this was logistically possible. In fact, modelling of the impact of OCV during an outbreak finds that when the vaccine supply is limited (as it is currently), more cases are prevented if a single dose strategy is used since a single dose can be provided to twice as many people. Even if the efficacy is a bit lower, the number of cases prevented will be higher. Even the individual person in this situation will be better off if more of his neighbors also receive vaccine since he benefits from the herd protection when more people are vaccinated.
A single dose strategy was used during an outbreak in Zambia in 2015-16, but this first dose was then followed up with a second dose after 6 to 8 months. I was also used in Haiti in 2016-17 following the hurricane. While the delayed second dose strategy has been used and will likely continue to be used during outbreaks or during humanitarian crises, there is no feasible way to assess the relative effectiveness against clinical cholera comparing a two-week interval with a delayed second dose strategy.
While clinical effectiveness trials are not feasible, serological responses comparing different dose intervals are possible. One such study found that vibriocidal titers were similar if the second dose was given either 2 week or 4 weeks after the first , but studies have not been done with longer dose intervals, as was used in Zambia and Haiti.
The proposed study will determine if giving the second dose of the OCV using a longer interval will result in a response to the second dose that is not inferior, or perhaps even results in a more prolonged elevated vibriocidal titre. From an immunological standpoint, there could be advantages to a longer dose interval if this resulted in a true booster response which sustained high titre of antibody. While acknowledging that the vibriocidal titer is not an established correlate of protection, it is the best correlate of the immune response following vaccination. It seems logical that a sustained high titer is likely to be more effective. Unfortunately, the clinical trials comparing the 2 week and 4 week interval with Shanchol only examined the serum titers shortly after the dosing (about 2 weeks). Follow-up serum samples were not obtained to discern how these dose intervals compared in terms of duration of elevated serum titres.
Recent studies have found that children <5 years of age are less well protected than older individuals even though their serum antibody response rates (take rates) were similar to the older subjects when the serum was collected about two weeks after the vaccine doses were administered. These immunogenicity studies have not, however, examined antibody titers when blood samples were obtained after a longer time interval. Therefore, it is not known if the antibody titers decline at the same rate as older subjects. It could be that GMT titers are lower or that titers fall more rapidly in the young children, and a different dosing interval could maintain higher titres. To compare antibody responses in different age groups, we plan to stratify groups into age 1-4, 5-14, and 15 years and older.
- Conditions
- Cholera, Vibrio Cholerae Infection
- Being tested
- Oral Cholera Vaccine, Adjusted Dose Oral Cholera Vaccine
- Keywords
- oral cholera vaccine, OCV, dose interval
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cholera VaccineBiological
Also called Shanchol
Shanchol is a bivalent (O1 and O139 serotypes) vaccine using a heat-killed classical Inaba strain and a formalin-killed classical Ogawa strain produced by Sanofi. Shanchol requires no oral buffer for administration, is approved for persons greater than 1 year of age, and requires 2 doses at two-week intervals. It became World Health Organization (WHO) prequalified in 2011.
Adjusted Dose Oral Cholera VaccineBiological
Also called Shanchol delayed dose
The Adjusted Dose Oral Cholera Vaccine is given in two doses, with the second dose given at six months, rather than the manufacturer described 2 week interval between first and second dose.
| Study group | Role | What they receive |
|---|---|---|
| Shanchol Dose-interval Group 1 | Active comparator | Participants in Dose-Interval Group 1 (DIG-1) will receive the oral cholera vaccine, Shanchol, according to the manufacturer instructions: in 2 doses at Day 0 and two weeks later (Day 14). Receives: Biological: Oral Cholera Vaccine |
| Shanchol Dose-Interval Group 2 | Experimental | Participants in Dose-Interval Group 2 (DIG-2) will receive the Adjusted Dose oral cholera vaccine, Shanchol, with a delayed second dose. The vaccine will be given at Day 0 and six months later. Receives: Biological: Adjusted Dose Oral Cholera Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vibriocidal GMT
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 or 6 months following the first dose of vaccine.
Measured: 6 months
Secondary outcomes (4)
Vibriocidal Antibody Response Rates
vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 months following the first dose of vaccine.
Measured: 2 weeks and 6 months
Age specific vibriocidal response
age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months months following the first dose of vaccine.
Measured: 2 weeks and 6 months
IgG ELISA Antibody Response
GMT and antibody response rates of IgG anti-LPS as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine.
Measured: 2 weeks and 6 months
IgA ELISA Antibody Response
GMT and antibody response rates of IgA anti-LPS as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine.
Measured: 2 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start16 Nov 2017
- Primary completion16 Oct 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open label, randomized, phase 2 clinical trial of the immunogenicity of OCV when the vaccine is administered to participants of three age cohorts (1-4 years, 5-14 years, and \>14 years) and in two dose interval groups (DIGs). The subjects in each age cohort will be randomized to a DIG of 2 weeks (DIG-1) or 6 months (DIG-2). A total of 120 subjects will be enrolled and these are equally divided between the different groups (20 per age/dose interval group).
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda K Debes, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373669
- Sponsor's protocol ID
- IRB00008066
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali M, Nelson AR, Lopez AL, Sack DA. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015 Jun 4;9(6):e0003832. doi: 10.1371/journal.pntd.0003832. eCollection 2015.
PubMed 26043000Sridhar S. An affordable cholera vaccine: an important step forward. Lancet. 2009 Nov 14;374(9702):1658-60. doi: 10.1016/S0140-6736(09)61418-5. Epub 2009 Oct 8. No abstract available.
PubMed 19819005Bi Q, Ferreras E, Pezzoli L, Legros D, Ivers LC, Date K, Qadri F, Digilio L, Sack DA, Ali M, Lessler J, Luquero FJ, Azman AS; Oral Cholera Vaccine Working Group of The Global Task Force on Cholera Control. Protection against cholera from killed whole-cell oral cholera vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2017 Oct;17(10):1080-1088. doi: 10.1016/S1473-3099(17)30359-6. Epub 2017 Jul 17.
PubMed 28729167Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2013 Dec;13(12):1050-6. doi: 10.1016/S1473-3099(13)70273-1. Epub 2013 Oct 18.
PubMed 24140390Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, Bannerjee B, Ali M, Dhingra MS, Chandra AM, Clemens JD, Sur D, Wierzba TF. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015 Mar 12;9(3):e0003574. doi: 10.1371/journal.pntd.0003574. eCollection 2015 Mar.
PubMed 25764513Mwaba J, Chisenga CC, Xiao S, Ng'ombe H, Banda E, Shea P, Mabula-Bwalya C, Mwila-Kazimbaya K, Laban NM, Alabi P, Chirwa-Chobe M, Simuyandi M, Harris J, Iyer AS, Bosomprah S, Scalzo P, Murt KN, Ram M, Kwenda G, Ali M, Sack DA, Chilengi R, Debes AK. Serum vibriocidal responses when second doses of oral cholera vaccine are delayed 6 months in Zambia. Vaccine. 2021 Jul 22;39(32):4516-4523. doi: 10.1016/j.vaccine.2021.06.034. Epub 2021 Jul 1.
PubMed 34217572
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. 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
- ClinicalTrials.gov ID
- NCT03373669
- Acronym / sponsor ID
- IRB00008066
- Conditions
- Cholera, Vibrio Cholerae Infection
- Keywords
- oral cholera vaccine, OCV, dose interval
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 Dec 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 a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
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, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 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 or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.
Detailed description
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
As described in the package insert, the standard dosing schedule of the OCV is two doses with the second dose given 2 weeks after the first. In several campaigns, it was felt to appropriate to give a single dose to twice as many people and to give the second dose at a later time when this was logistically possible. In fact, modelling of the impact of OCV during an outbreak finds that when the vaccine supply is limited (as it is currently), more cases are prevented if a single dose strategy is used since a single dose can be provided to twice as many people. Even if the efficacy is a bit lower, the number of cases prevented will be higher. Even the individual person in this situation will be better off if more of his neighbors also receive vaccine since he benefits from the herd protection when more people are vaccinated.
A single dose strategy was used during an outbreak in Zambia in 2015-16, but this first dose was then followed up with a second dose after 6 to 8 months. I was also used in Haiti in 2016-17 following the hurricane. While the delayed second dose strategy has been used and will likely continue to be used during outbreaks or during humanitarian crises, there is no feasible way to assess the relative effectiveness against clinical cholera comparing a two-week interval with a delayed second dose strategy.
While clinical effectiveness trials are not feasible, serological responses comparing different dose intervals are possible. One such study found that vibriocidal titers were similar if the second dose was given either 2 week or 4 weeks after the first , but studies have not been done with longer dose intervals, as was used in Zambia and Haiti.
The proposed study will determine if giving the second dose of the OCV using a longer interval will result in a response to the second dose that is not inferior, or perhaps even results in a more prolonged elevated vibriocidal titre. From an immunological standpoint, there could be advantages to a longer dose interval if this resulted in a true booster response which sustained high titre of antibody. While acknowledging that the vibriocidal titer is not an established correlate of protection, it is the best correlate of the immune response following vaccination. It seems logical that a sustained high titer is likely to be more effective. Unfortunately, the clinical trials comparing the 2 week and 4 week interval with Shanchol only examined the serum titers shortly after the dosing (about 2 weeks). Follow-up serum samples were not obtained to discern how these dose intervals compared in terms of duration of elevated serum titres.
Recent studies have found that children <5 years of age are less well protected than older individuals even though their serum antibody response rates (take rates) were similar to the older subjects when the serum was collected about two weeks after the vaccine doses were administered. These immunogenicity studies have not, however, examined antibody titers when blood samples were obtained after a longer time interval. Therefore, it is not known if the antibody titers decline at the same rate as older subjects. It could be that GMT titers are lower or that titers fall more rapidly in the young children, and a different dosing interval could maintain higher titres. To compare antibody responses in different age groups, we plan to stratify groups into age 1-4, 5-14, and 15 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open label, randomized, phase 2 clinical trial of the immunogenicity of OCV when the vaccine is administered to participants of three age cohorts (1-4 years, 5-14 years, and >14 years) and in two dose interval groups (DIGs). The subjects in each age cohort will be randomized to a DIG of 2 weeks (DIG-1) or 6 months (DIG-2). A total of 120 subjects will be enrolled and these are equally divided between the different groups (20 per age/dose interval group).
| Arm | Type | Receives |
|---|---|---|
| Shanchol Dose-interval Group 1 | Active comparator | Biological: Oral Cholera VaccineParticipants in Dose-Interval Group 1 (DIG-1) will receive the oral cholera vaccine, Shanchol, according to the manufacturer instructions: in 2 doses at Day 0 and two weeks later (Day 14). |
| Shanchol Dose-Interval Group 2 | Experimental | Biological: Adjusted Dose Oral Cholera VaccineParticipants in Dose-Interval Group 2 (DIG-2) will receive the Adjusted Dose oral cholera vaccine, Shanchol, with a delayed second dose. The vaccine will be given at Day 0 and six months later. |
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 Waya Clinic Catchment 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 9 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 |
|---|---|---|
| Oral Cholera VaccineAlso: ShancholShanchol is a bivalent (O1 and O139 serotypes) vaccine using a heat-killed classical Inaba strain and a formalin-killed classical Ogawa strain produced by Sanofi. Shanchol requires no oral buffer for administration, is approved for persons greater than 1 year of age, and requires 2 doses at two-week intervals. It became World Health Organization (WHO) prequalified in 2011. | Biological | Shanchol Dose-interval Group 1 |
| Adjusted Dose Oral Cholera VaccineAlso: Shanchol delayed doseThe Adjusted Dose Oral Cholera Vaccine is given in two doses, with the second dose given at six months, rather than the manufacturer described 2 week interval between first and second dose. | Biological | Shanchol Dose-Interval Group 2 |
Primary outcome
Change in Vibriocidal GMT
Time frame: 6 months
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 or 6 months following the first dose of vaccine.
4 secondary outcomes
Vibriocidal Antibody Response Rates
Time frame: 2 weeks and 6 months
Age specific vibriocidal response
Time frame: 2 weeks and 6 months
IgG ELISA Antibody Response
Time frame: 2 weeks and 6 months
IgA ELISA Antibody Response
Time frame: 2 weeks and 6 months
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 Apr 2021.
- Background: PubMed 26043000Ali M, Nelson AR, Lopez AL, Sack DA. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015 Jun 4;9(6):e0003832. doi: 10.1371/journal.pntd.0003832. eCollection 2015.
- Background: PubMed 19819005Sridhar S. An affordable cholera vaccine: an important step forward. Lancet. 2009 Nov 14;374(9702):1658-60. doi: 10.1016/S0140-6736(09)61418-5. Epub 2009 Oct 8. No abstract available.
- Background: PubMed 28729167Bi Q, Ferreras E, Pezzoli L, Legros D, Ivers LC, Date K, Qadri F, Digilio L, Sack DA, Ali M, Lessler J, Luquero FJ, Azman AS; Oral Cholera Vaccine Working Group of The Global Task Force on Cholera Control. Protection against cholera from killed whole-cell oral cholera vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2017 Oct;17(10):1080-1088. doi: 10.1016/S1473-3099(17)30359-6. Epub 2017 Jul 17.
- Background: PubMed 24140390Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2013 Dec;13(12):1050-6. doi: 10.1016/S1473-3099(13)70273-1. Epub 2013 Oct 18.
- Background: PubMed 25764513Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, Bannerjee B, Ali M, Dhingra MS, Chandra AM, Clemens JD, Sur D, Wierzba TF. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015 Mar 12;9(3):e0003574. doi: 10.1371/journal.pntd.0003574. eCollection 2015 Mar.
- Derived from this study: PubMed 34217572Mwaba J, Chisenga CC, Xiao S, Ng'ombe H, Banda E, Shea P, Mabula-Bwalya C, Mwila-Kazimbaya K, Laban NM, Alabi P, Chirwa-Chobe M, Simuyandi M, Harris J, Iyer AS, Bosomprah S, Scalzo P, Murt KN, Ram M, Kwenda G, Ali M, Sack DA, Chilengi R, Debes AK. Serum vibriocidal responses when second doses of oral cholera vaccine are delayed 6 months in Zambia. Vaccine. 2021 Jul 22;39(32):4516-4523. doi: 10.1016/j.vaccine.2021.06.034. Epub 2021 Jul 1.
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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.
Amanda K Debes, PhD 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 4 study testing Oral Cholera Vaccine and Adjusted Dose Oral Cholera Vaccine in people with Cholera and Vibrio Cholerae Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
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 Apr 2021. 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 Zambia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Vibriocidal GMT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373669, which also lists 6 linked publications.
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 Apr 2021.