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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02388009
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborators:
Wellcome Trust
Naval Medical Research Center
Information provided by (Responsible Party):
LimmaTech Biologics AG

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Shigellosis Biological: Flexyn2a Biological: Placebo Biological: Flexyn2a plus adjuvant Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers
Study Start Date : February 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Flexyn2a
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
Biological: Flexyn2a
Intramuscular doses of 0.5 mL

Active Comparator: Flexyn2a plus adjuvant
2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart
Biological: Flexyn2a plus adjuvant
Intramuscular doses of 0.5 mL

Placebo Comparator: Placebo
2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart
Biological: Placebo
Intramuscular doses of 0.5 mL




Primary Outcome Measures :
  1. Occurrence and severity of adverse events [ Time Frame: until Day 56 ]
    Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study


Secondary Outcome Measures :
  1. Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups. [ Time Frame: until Day 56 ]
    Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels

  2. Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant [ Time Frame: until Day 56 ]
    Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388009


Locations
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United States, Maryland
WRAIR Clinical Trial Center (CTC)
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
LimmaTech Biologics AG
Wellcome Trust
Naval Medical Research Center
Investigators
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Principal Investigator: Mark S. Riddle, MD Dr Ph Navy Medical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LimmaTech Biologics AG
ClinicalTrials.gov Identifier: NCT02388009     History of Changes
Other Study ID Numbers: SF2A-1
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by LimmaTech Biologics AG:
bioconjugate vaccine
safety
immunogenicity
shigellosis

Additional relevant MeSH terms:
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Dysentery, Bacillary
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs