Completed

Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine

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What is being tested

Data Collection

Who is being recruted

Diarrhea

+ Signs and Symptoms, Digestive

From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorU.S. Army Medical Research and Development Command
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24 allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart: Test articles/dose Group / N\* / Invaplex 50 A / 8 / 10 micrograms B / 8 / 50 micrograms C / 8 / 240 micrograms D / 8 / 480 micrograms \*minimum of 6 volunteers/group An interval no less than 7 days following the third (and final) dose (total of 35 days between initial dose at the lower dose level and the next initial dose at the next higher dose level) will separate volunteer groups receiving different doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+- one day), and the third is Day 28 (+- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccination dose.

Official TitleSafety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine 
NCT00082069
Principal SponsorU.S. Army Medical Research and Development Command
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DiarrheaSigns and Symptoms, Digestive

Criteria

Inclusion Criteria: * Be in very good health. Exclusion Criteria: * Smoker, or have stopped smoking less than one year ago * Pregnant * History of chronic illnesses, such as: asthma, chronic sinusitis, or chronic seasonal allergies (such as hay fever) * Received a vaccination for Shigella or exposure to Shigella bacteria in a research study or through work in a laboratory * Positive for HIV, hepatitis B, and hepatitis C by blood test * Using anti-diarrheal, anti-constipation, or antacid medications on a regular basis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Walter Reed Army Institute of Research

Silver Spring, United StatesSee the location
CompletedOne Study Center