Digestive System
Conditions
Interventions
Sodium Bicarbonate Buffer
Sponsors
Scandinavian Biopharma Holding AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy children 6 to 18 months old at the time of enrolment. 2. Generally good health over the 7 days before enrolment and the day of 1st dose of vaccine/placebo. 3. Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form. 4. Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period.
Exclusion criteria
Exclusion criteria: 1. Presence of any significant known systemic disorder 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 precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. 3. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrolment. 4. Participation in research involving another investigational product 30 days before planned date of first vaccination. 5. Receiving any other vaccines given within 7 days before ETVAX® vaccination. 6. Antibiotics administered within 7 days before ETVAX® vaccination. 7. Febrile illness within 48 hours prior to vaccination or documented fever at the time of immunization (fever is defined as a temp = 37.5°C) 8. Prior receipt of Dukoral, an oral cholera vaccine, or any ETEC vaccine. 9. Prior receipt of a blood transfusion or blood products, including immunoglobulins. 10. Current use of iron or zinc supplements within the past 7 days. 11. Current use of antacids (H2 blockers, omeprazole, over the counter agents or immunosuppressive drug within the past 7 days. 12. Any condition that in the opinion of the PI might jeopardize the safety of study participants or interfere with the evaluation of the study objectives. 13. Diarrhoea during 7 days before vaccination. 14. Acute disease at the time of enrolment or during the 3 days prior to enrolment. 15. Participant’s parents not able, available or willing to accept active follow-up by the study staff. 16. History of chronic administration (defined as more than 14 days) of immunosuppressants 17. Malnutrition (wt-for-ht z-score <-2.0)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety •Occurrence of serious adverse events (SAEs) among all enrolled children from receipt of the first vaccine dose to end of trial and among the reactogenicity cohort (n=350), reactogenicity and adverse events (AEs) identified during 7 days after receiving each dose of vaccine. ;Efficacy •The first episode of clinically significant acute diarrhoea associated with culture-detected ETEC expressing CFA/I, CS3, CS5, CS6 and/or LT-enterotoxin without co-pathogens among children 6 to 18 months of age receiving two doses and a booster dose (three doses) and detected from 7 days after receiving the third dose of vaccine or placebo through, on average, 18 months of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The first episode of clinically significant (moderate-to-severe) acute diarrhoea associated with culture-detected ETEC expressing CFA/I, CS3, CS5, CS6 and/or LT-enterotoxin without copathogens among children 6 to 18 months of age receiving two doses of ETVAX with dmLT or placebo detected from 7 days after receiving the second dose of vaccine or placebo through day 90 • The first episode of clinically significant acute diarrhoea associated with culture-detected ETEC regardless of CF or enterotoxin without copathogens among children 6 to 18 months of age receiving three doses of vaccine or placebo detected from 7 days after receiving the third dose through, on average, 18 months of follow up. • The first episode of clinically significant acute diarrhoea episodes regardless of etiology among children 6 to 18 months of age receiving three doses of vaccine or placebo detected from 7 days after receiving the third dose through, on average, 18 months of follow up. • The first episode of moderate to severe diarrhoea with three or more loose or liquid stools associated with ETEC expressing CFA/I, CS3, CS5, CS6 or LTenterotoxin from 7 days after the second dose to third dose and from 7 days after the third dose to study end.;Immunology: • In a subset of participants (n=150), the proportion of individuals mounting a serum IgA antibody response detected by ELISA to at least one, two, three, four and five of the five primary vaccine antigens (= two-fold increase in antibody titres between baseline and after the second and/or third vaccine dose). • The proportion of participants in the subset, mounting a serum IgG antibody response detected by ELISA against LTB (= two-fold increase in antibody titres between baseline and after the second and/or third vaccine dose. | — |
Countries
Gambia
Contacts
Public ContactAndrea Westerdahl
Clinical Operations Mgr at Scandinavian Biopharma
Outcome results
None listed