Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
NCT ID: NCT02388009
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2015-02-28
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flexyn2a
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
Flexyn2a
Intramuscular doses of 0.5 mL
Flexyn2a plus adjuvant
2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart
Flexyn2a plus adjuvant
Intramuscular doses of 0.5 mL
Placebo
2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart
Placebo
Intramuscular doses of 0.5 mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flexyn2a
Intramuscular doses of 0.5 mL
Placebo
Intramuscular doses of 0.5 mL
Flexyn2a plus adjuvant
Intramuscular doses of 0.5 mL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wellcome Trust
OTHER
Naval Medical Research Center
FED
LimmaTech Biologics AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark S. Riddle, MD Dr Ph
Role: PRINCIPAL_INVESTIGATOR
Navy Medical Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
WRAIR Clinical Trial Center (CTC)
Silver Spring, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Riddle MS, Kaminski RW, Di Paolo C, Porter CK, Gutierrez RL, Clarkson KA, Weerts HE, Duplessis C, Castellano A, Alaimo C, Paolino K, Gormley R, Gambillara Fonck V. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study. Clin Vaccine Immunol. 2016 Dec 5;23(12):908-917. doi: 10.1128/CVI.00224-16. Print 2016 Dec.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SF2A-1
Identifier Type: -
Identifier Source: org_study_id