Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
3 other identifiers
interventional
113
1 country
2
Brief Summary
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2007
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 11, 2007
CompletedFirst Posted
Study publicly available on registry
June 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
September 11, 2017
CompletedSeptember 11, 2017
August 1, 2017
2.2 years
June 11, 2007
October 24, 2016
August 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).
7 days after challenge
Secondary Outcomes (5)
Post-challenge Loose Stool Samples Occurrences by Study Group
7 days after challenge
Post-challenge Loose Stool Sample Volumes by Study Group
7 days after challenge
Post-challenge Loose Stool Sample Durations by Study Group
7 days after challenge
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
56 days post-challenge
Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS
56 days post-vaccination in stage 1
Study Arms (6)
Stage 1: Group A, Dolphin 240 µg
EXPERIMENTAL240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of lipopolysaccharides (LPS). 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (DolphinTM).
Stage 1: Group B, Dolphin 480 µg
EXPERIMENTAL480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (DolphinTM).
Stage 1: Group C, Dolphin 690 µg
EXPERIMENTAL690 Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (DolphinTM).
Stage 1: Group D, Pipette 240 µg
OTHER240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.
Stage 2: Immunized / Challenge
OTHERThe selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.
Stage 2: Controls
PLACEBO COMPARATORA control was to be administered with the DolphinTM using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.
Interventions
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T
Eligibility Criteria
You may qualify if:
- Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved ≥ 70% accuracy).
- Signed informed consent form.
- 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 during the study or within two (2) months following study completion.
You may not qualify if:
- General Health
- Health problems affecting study participation from medical history specifically to include chronic medical conditions such as psychiatric conditions, diabetes mellitus and hypertension or any other condition requiring chronic daily therapy that would place the volunteer at increased risk - as determined by a study physician, current use of antihypertensive medications, or other medications that may interact with pseudoephedrine in the event it is required to treat rhinorrhea).
- Clinically significant abnormalities on physical examination.
- 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) 30 days before planned date of first vaccination or anytime throughout the duration of the study.
- Positive blood test for HBsAG, HCV, HIV-1.
- Clinically significant abnormalities on basic laboratory screening.
- Immunosuppressive illness or IgA deficiency (below the normal limits).
- Research specific
- Presence of nasal polyps, ulcers, or deviated nasal septum (further defined in section 4.2).
- History of chronic sinusitis or chronic/seasonal rhinitis (further defined in section 4.2)
- History of rhinoplasty.
- History of reactive airway disease (asthma), chronic obstructive pulmonary disease, or chronic bronchitis.
- History of Bell's palsy.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Immunization Research (CIR) John Hopkins Bayview Medical Center
Baltimore, Maryland, 21287, United States
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, 20910, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Division of Regulated Activies and Compliance
- Organization
- US Army Medical Materiel Development Activity (USAMMDA)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Riddle, MD
Naval Medical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2007
First Posted
June 12, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2009
Study Completion
September 1, 2010
Last Updated
September 11, 2017
Results First Posted
September 11, 2017
Record last verified: 2017-08