Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection

Completed · Phase 1/Phase 2

Conditions studied: Shigellosis

In brief

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.

Key facts

Study ID

NCT00485134

Run by

U.S. Army Medical Research and Development Command

People needed

113

Starts

2007-05-01

Expected to finish

2010-09-01

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.
• Current smoker or smoker in past 3 months ('smoker' defined as daily cigarette cigar, or pipe use for a period of at least 1 month).
• Regular use (weekly or more often of antidiarrheal, anti-constipation, or antacid therapy
• Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.
• Personal or family history of an inflammatory arthritis.
• Positive blood test for HLA-B27.
• Prior exposure to Shigella
• History of microbiologically confirmed Shigella infection.
• Received previous experimental Shigella vaccine or live Shigella challenge.
• Travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within two years prior to dosing.
• Occupation involving handling of Shigella bacteria currently, or in the past 3 years.

Where it is running

• Center for Immunization Research (CIR) John Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Department of Clinical Trials, WRAIR — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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