Cholera
Conditions
Interventions
ORAVAC
Sponsors
Zambia National Public Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =2 years 2. Healthy, without clinically significant medical history assessed by physician 3. Women of childbearing potential: negative pregnancy test at screening and before each study vaccine administration and must agree to use continuous highly effective contraception to avoid pregnancy during the study, for at least 4 weeks before the first vaccination and for 3 months following the last vaccine dose 4. Available to participate for the study duration, including all planned follow-up visits for up to 18 months from screening. 5. Provide written informed consent or assent before initiation of any study procedures
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of hypersensitivity reactions to other preventive vaccines. 2. Severe chronic disease or psychiatric condition 3. Receipt of blood or blood-derived products in the past 3 months 4. Ever having received oral cholera vaccine 5. Receipt of an investigational product (within 30 days before vaccination). 6. Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months. 7. History of diarrhoea in 7 days prior to first dose of vaccine (defined as =3 unformed loose stools in 24 hours). 8. History of chronic diarrhoea (lasting for more than 2 weeks in the past 6 months) 9. Any other criteria which, in the investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The independent variable in this study is the OraVac vaccine.It is the intervention or treatment being studied to determine its effect on safety and immunogenicity outcomes. Primary endpoint indicators Positive conversion rate of anti-cholera toxin (CT) antibodies in serum on day 49 after the first dose of vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of positive serum conversions for Vibrio abortus antibodies (Vab) on day 49 after the first dose of vaccine;;Vibrio abortus antibody (Vab) titre level and positive conversion rate in serum on days 7, 28, 49, 180, 270, and 360 after the first dose of vaccine ;The titre level and positive conversion rate of anti-CT antibody in serum at days 7, 28, 49, 180, 270, and 360 after the first dose of vaccine;Serum titre levels of anti-Toxigenic E. coli heat-resistant toxin B (LTB) antibodies at days 7, 28, 49, 180, 270, and 360 after the first dose of vaccine;Incidence of local and systemic clinical reactions and associated adverse reactions/events occurs during all observation periods | — |
Countries
Zambia
Contacts
Public ContactChilombo Mwambazi
Study Coordinator
Outcome results
None listed