Antibody avidity and immunological memory induced by oral cholera vaccinatio

Phase 2

Completed

• Conditions: Diarrhoea caused by enterotoxigenic Escherichia coli (ETEC) and Vibrio cholerae bacteria; Infections and Infestations; Infectious diarrhoea NOS

• Registration Number: ISRCTN11806026
• Lead Sponsor: Göteborg University Vaccine Research Institute (GUVAX)

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31703936 results (added 11/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33828557/ (added 07/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-06
• Study Completion: 2018-02-01
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Male or female aged 18-55 years
2. Healthy constitution as established by medical history
3. Give written informed consent to participate
4. Willing and able to communicate with the investigators and understand the requirements of the study

Exclusion Criteria

1. An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to, gastrointestinal diseases and autoimmune diseases. Gastroenteritis within two weeks prior to the first vaccination or during vaccination.
2. Antibiotic therapy within six weeks prior to the first vaccination or during the study period.
3. Known Hepatitis A, B, C and/or HIV infection.
4. Concomitant intake of immunomodulating drugs during the study period or less than four weeks prior to the first immunisation.
5. Psychiatric symptoms and treatments during the last year deemed by the investigator/physician to be relevant for participation in the study.
6. Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination.
7. Any known hypersensitivity to any ingredient in the vaccine.
8. Has received Dukoral or any ETEC vaccine.
9. Brought up in ETEC-endemic areas (e.g., Central and South America, Caribbean, most countries in Asia, Africa, etc.).
10. Has travelled to ETEC-endemic areas within the last 3 years, or travelled repeatedly and/or spent > two months in ETEC endemic areas during the last 10 years.
11. Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician.
12. Receipt of any other investigational product in the month before study entry or during the study deemed by the investigator/physician to be relevant for the OVM study.
13. Concomitant participation in any other clinical study deemed by the investigator/physician to be relevant for the OVM study.
14. Intends to donate blood during the study.
15. Females who are pregnant or nursing.
16. Sexually active females who unless being menopausal do not agree to use reliable contraception as assessed by the investigator, from inclusion to last study visit.
17. Unable to participate in all study visits.
18. Any condition or circumstance which would make the subject unsuitable for participation in the study in the opinion of the investigator/physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The antibody avidity and immunological memory in fully primed subjects, measured using KSCN elution and/or limiting antigen dilution and ELISA, measured day 19 after primary vaccination (i.e. 5 days after the second dose) and day 5 after booster vaccination.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Immunological responses in fully primed subjects, quantified using flow cytometric and RNAseq techniques, assessed on day 5 post booster vaccination<br> 2. The immunological responses to oral cholera vaccine Dukoral in subjects with secretor or non-secretor phenotype, as measured using ELISA at day 0, 19 and day 44 post vaccination<br>