Digestive System
Conditions
Interventions
Cohort A adults 18 to 45 years
Cohort A adults 18 to 45 years inclusive
Cohort B1 children 10 to 23 months inclusive
Cohort B1 Children 10 to 23 months inclusive
Cohort B2 Children 10 to 23 months inclusive
Cohort C1 infants 6 to 9 months inclusive
Cohort C2 infants 6 to 9 months inclusive
Sponsors
Scandinavian Biopharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy male or non-pregnant female adults ages 18 to 45 years old and children =6 and =23 months old at the time of enrolment, all inclusive. • General good health as determined by the screening evaluation conducted 1-7 days before enrolment and vaccination. • Adult subjects or parents to children properly informed about the study, able to understand it and sign or thumbprint the informed consent form. • Subject, parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period. • Willing to comply with all stipulated study procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant’s health or is likely to result in non-conformance to the protocol. 2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator or designee precludes participation in the study. 3. Known or suspected impairment of immunological function based on medical history and physical examination. 4. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrolment 5. Participation in a research study involving another investigational product (defined as receipt of investigational product) including 30 days before planned date of first vaccination. 6. History of receiving any other vaccine within 7 days before ETVAX® vaccination. 7. Antibiotic administered within 7days before ETVAX® vaccination. 8. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature = 37.5 C ) on axillary measurement 9. Prior receipt of oral cholera vaccine (specifically Dukoral®) or any ETEC vaccine. 10. Prior receipt of a blood transfusion or blood products, including immunoglobulins. 11. Current use of iron or zinc supplements within the past 7 days; 12. Current use of antacids (H2 blockers, omeprazole, OTC agents) within the past 7 days 13. current use of immunosuppressive drug (e.g steroids) within the past 7 days. 14. Receipt of antimicrobial drugs for any reason within 7 days before vaccination 15. History of diarrhoea during the 7 days before vaccination 16. Acute disease at the time of enrolment or during the 3 days prior to enrolment 17. Participant’s or parents/guardians not being able to or unwilling to accept active follow-up by the study staff 18. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study 19. Medically significant malnutrition, defined as moderate or more severe malnutrition (BMI <18.5 kg/m2 for Cohort A, weight-for-height z-score < - 2.0 SD for Cohort B and C) 20. Any condition which in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed by analyses of the following primary endpoints (events), where the unit of analysis in each case will be the proportion of participants with at least one event: •Solicited gastrointestinal reactions •Solicited systemic reactions •Unsolicited adverse events •Adverse events where there is a reasonable possibility that the study product caused the event, i.e., are suspected adverse drug reactions •Serious adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity Analysis for all immunological analyses, the response rate and magnitude of antigen-specific responses will be analyzed after second and third immunization as specimen availability allows. Response rates to the five primary antigens in the ETVAX® vaccine (LTB, CFA/I, CS3, CS5, and CS6) will be further evaluated to address co-secondary immunogenicity hypothesis by analyzing the response rates to at least three of the five different antigens by faecal SIgA and plasma IgA. The specific objective about to assess memory B-cell responses to LTB, CFA/I, CS3, CS5 and CS6 on adults was relabeled to an exploratory objective. The analysis of this exploratory objective will be addressed later on and results reported through an academic PhD research project at CIDRZ. | — |
Countries
Zambia
Contacts
Public ContactHope Mwanyungwi
Head of Research Operations CIDRZ
Outcome results
None listed