Invaplex 50 Vaccine Dose-Ranging - Tabular View

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Invaplex 50 Vaccine Dose-Ranging

This study is ongoing, but not recruiting participants.

Study NCT00082069. Last updated on November 1, 2006. Information provided by Walter Reed Army Institute of Research (WRAIR)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Invaplex 50 Vaccine Dose-Ranging

Official Title ^†

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

Brief Summary

The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.

Detailed Description

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Safety
Mucosal immune response
Systemic immune response

Secondary Outcome Measure ^†

Condition ^†

Diarrhea

Intervention ^†

Biological: Shigella flexneri 2a Invaplex 50

MEDLINE PMIDs

Links

Clinical Trials Center website This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

April 2004

Completion Date

November 2006

Eligibility 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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00082069

Organization ID

NMRC 2003.0008

Secondary IDs ^††

WRAIR 1085, HSRRB A-12528, Invaplex50

Study Sponsor ^†

U.S. Army Office of the Surgeon General

Collaborators ^††

Investigators ^†

Principal Investigator:

David Tribble, MD, PhD

Naval Medical Research Center

Information Provided By

Walter Reed Army Institute of Research (WRAIR)

Verification Date

November 2006

First Received Date ^†

April 28, 2004

Last Updated Date

November 1, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.