Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults

• Status: Completed
• Trial end date: 2021-06-21
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.

The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.

This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eveliqure Biotechnologies GmbH

Criteria

Inclusion Criteria:

1. Generally healthy male and non-pregnant, non-nursing female adults aged 18 to 45 years

2. Who are determined by medical history, physical examination and clinical judgment to be eligible for this study;

3. Who provide written informed consent after the nature of the study had been explained;

4. Who are available for the two to three months duration of follow-up (from enrolment to study completion);

5. Who are available to be interviewed by study staff for the 2-month post-immunization follow-up;

Exclusion Criteria:

1. Subjects who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;

2. Who have a known or suspected disease of cancer (excluding healed skin lesions), the immune system, or those who are receiving immunosuppressive therapy, including systemic corticosteroids or cytotoxic agents;

3. Who have received any blood products, including immunoglobulin, in the period from six months prior to vaccination or are anticipated to receive such products through to the conclusion of the study;

4. Who have ever received a cholera vaccine;

5. Who are receiving antibiotics or completed antibiotic therapy in previous 7 days;

6. Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product or the biological effects of such experimental products prior to vaccination or received a licensed vaccine in the 30 days prior to vaccination;

7. Who have a chronic non-gastrointestinal medical condition (e.g. hypertension, hyperlipidemia) that is not well controlled with medication;

8. Who have a significant history of or current diagnosis of diseases of the gastrointestinal tract (i.e. liver, gallbladder, bowel, or stomach), are on medication for such disease, or have had significant bowel surgery (with the exclusion of hernia repair or appendectomy);

9. Who have significant abnormality of blood chemistry, hematology, or screening tests (including tests for hepatitis B, HIV, HCV);

10. Who have a history of reactive arthritis following GI infection;

11. Who expect to work in the subsequent 2 weeks as a food handler or in direct patient, child day care, or elder care;

12. Who have immunocompromised household member;

13. Who have ever had a diagnosed Shigella or ETEC infection;

14. Who have developed symptoms of Shigella or ETEC infections after having travelled to Shigella or ETEC endemic areas in the past 12 months;

15. Who have any condition which in the opinion of the investigator puts the subject at risk of non-compliance with the protocol;

16. Who have known allergy to quinolone or azithromycin that will be used in the study;

17. Who are HLA-B27 positive (a possible risk factor for reactive arthritis following naturally acquired bacterial gastrointestinal infection).

18. Who are dependent of the Sponsor, of the investigational team or his/her immediate family, or are medical students at the Clinical Trial Study Site in Debrecen.

19. Who are living in community (i.e. students living in a dormitory).

20. Who are positive for CoVID19 infection by PCR testing prior to randomization.