Expired Study
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Silver Spring, Maryland 20910


Purpose:

This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.


Study summary:

A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group. For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.


Criteria:

Inclusion Criteria: 1. Healthy male or female volunteers, age of 18 to 50 years (inclusive) at the time of enrollment. 2. Signed informed consent form. 3. Completion and review of comprehension test (achieved >70% accuracy) 4. Available for the required follow-up period and scheduled clinic visits. 5. Women: negative pregnancy test with understanding (through informed consent process) to not become pregnant or or breastfeed during the study or within twelve (12) weeks after the last vaccine dose. Exclusion Criteria: 1. Health condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of adverse Events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate. 2. Clinically significant abnormalities on physical examination. 3. Clinically significant abnormalities on basic laboratory screening. 4. Presence of significant unexplained laboratory abnormalities that, in the opinion of the PI, may potentially confound the analysis of the study results 5. Regular use of constipation, antacid or anti-diarrheal medications or treatments. 6. Abnormal stool pattern (fewer than 3 stools per week or more than 3 per day) or loose/liquid stools more than occasionally. 7. Use of immunosuppressive drugs such as corticosteroids or chemotherapeutics that may influence antibody development. 8. Women currently nursing. 9. Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) within 30 days of planned date of first vaccination or anytime throughout the duration of the study. 10. Positive blood test for HBsAg, hepatitis C Virus (HCV), HIV-1. 11. Positive blood test for HLA-B27. 12. Immunosuppressive illness or immunoglobulin deficiency (serum immunoglobulin A level < 7 mg/dL or limit of detection of assay). 13. Family history of congenital or hereditary immunodeficiency. 14. Treatment with immunoglobulins or blood products within 3 months from first candidate vaccine injection. 15. History of microbiologically confirmed Shigella infection. 16. Personal or family history of inflammatory arthritis. 17. Personal or family history of irritable bowel syndrome. 18. Received previous experimental Shigella vaccine or live Shigella challenge. 19. Have had diarrhea while traveling outside the United States or lived for 2 or more months during the past 3 years in a country with potentially higher Shigella infection rates, including Africa, South America, Central America, and Asia (except Japan). 20. Occupation involving handling of Shigella bacteria currently, or in the past 3 years. 21. History of allergy to any vaccine. 22. History of allergy to aluminum hydroxide. 23. Serum immunoglobulin G endpoint titer ≥ 2500 to Shigella Lipopolysaccharide.


Study is Available At:


Original ID:

SF2A-1


NCT ID:

NCT02388009


Secondary ID:


Study Acronym:


Brief Title:

Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a


Official Title:

Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

LimmaTech Biologics AG


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark S. Riddle, MD Dr Ph
Principal Investigator
Navy Medical Research Center

Study Dates

Start Date:February 2015
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:May 2015
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 21, 2015
First Received Date:February 23, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant
Time Frame:until Day 56
Safety Issues:False
Description:Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection
Outcome Type:Secondary Outcome
Measure:Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups.
Time Frame:until Day 56
Safety Issues:False
Description:Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels
Outcome Type:Primary Outcome
Measure:Occurrence and severity of adverse events
Time Frame:until Day 56
Safety Issues:True
Description:Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study

Study Interventions

Intervention Type:Biological
Name:Flexyn2a
Description:Intramuscular doses of 0.5 mL
Arm Name:Flexyn2a
Intervention Type:Biological
Name:Placebo
Description:Intramuscular doses of 0.5 mL
Arm Name:Placebo
Intervention Type:Biological
Name:Flexyn2a plus adjuvant
Description:Intramuscular doses of 0.5 mL
Arm Name:Flexyn2a plus adjuvant

Study Arms

Study Arm Type:Active Comparator
Arm Name:Flexyn2a
Description:2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
Study Arm Type:Active Comparator
Arm Name:Flexyn2a plus adjuvant
Description:2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:LimmaTech Biologics AG
Agency Class:Other
Agency Type:Collaborator
Agency Name:Wellcome Trust

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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