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

NCT02388009 | Completed Phase 1

• 1 other identifier: SF2A-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Shigellosis

Keywords

bioconjugate vaccine; safety; immunogenicity; shigellosis

Outcome Measures

Primary Outcomes (1)

• Occurrence and severity of adverse events

  Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study

  until Day 56

Secondary Outcomes (2)

• Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups.

  until Day 56

• Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant

  until Day 56

Study Arms (3)

Flexyn2a

ACTIVE COMPARATOR

2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart

Biological: Flexyn2a

Flexyn2a plus adjuvant

ACTIVE COMPARATOR

2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart

Biological: Flexyn2a plus adjuvant

Placebo

PLACEBO COMPARATOR

2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart

Biological: Placebo

Interventions

Flexyn2a BIOLOGICAL

Intramuscular doses of 0.5 mL

Flexyn2a

Placebo BIOLOGICAL

Intramuscular doses of 0.5 mL

Placebo

Flexyn2a plus adjuvant BIOLOGICAL

Intramuscular doses of 0.5 mL

Flexyn2a plus adjuvant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteers, age of 18 to 50 years (inclusive) at the time of enrollment.
• Signed informed consent form.
• Completion and review of comprehension test (achieved \>70% accuracy)
• Available for the required follow-up period and scheduled clinic visits.
• 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.

You may not qualify if:

• 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.
• Clinically significant abnormalities on physical examination.
• Clinically significant abnormalities on basic laboratory screening.
• Presence of significant unexplained laboratory abnormalities that, in the opinion of the PI, may potentially confound the analysis of the study results
• Regular use of constipation, antacid or anti-diarrheal medications or treatments.
• Abnormal stool pattern (fewer than 3 stools per week or more than 3 per day) or loose/liquid stools more than occasionally.
• Use of immunosuppressive drugs such as corticosteroids or chemotherapeutics that may influence antibody development.
• Women currently nursing.
• 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.
• Positive blood test for HBsAg, hepatitis C Virus (HCV), HIV-1.
• Positive blood test for HLA-B27.
• Immunosuppressive illness or immunoglobulin deficiency (serum immunoglobulin A level \< 7 mg/dL or limit of detection of assay).
• Family history of congenital or hereditary immunodeficiency.
• Treatment with immunoglobulins or blood products within 3 months from first candidate vaccine injection.
• History of microbiologically confirmed Shigella infection.

Sponsors & Collaborators

• LimmaTech Biologics AG: lead
• Wellcome Trust: collaborator
• Naval Medical Research Center: collaborator

Study Sites (1)

WRAIR Clinical Trial Center (CTC)

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

• 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.

  PMID: 27581434 DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Mark S. Riddle, MD Dr Ph

  Navy Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 13, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

US (1)