Invaplex 50 Vaccine Dose-Ranging - Tabular View

Tracking Information

First Received Date ^ICMJE

April 28, 2004

Last Updated Date

November 1, 2006

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety
Mucosal immune response
Systemic immune response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00082069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Invaplex 50 Vaccine Dose-Ranging

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Diarrhea

Intervention ^ICMJE

Biological: Shigella flexneri 2a Invaplex 50

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00082069

Responsible Party

Study ID Numbers ^ICMJE

NMRC 2003.0008, WRAIR 1085, HSRRB A-12528, Invaplex50

Study Sponsor ^ICMJE

U.S. Army Office of the Surgeon General

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David Tribble, MD, PhD

Naval Medical Research Center

Information Provided By

Walter Reed Army Institute of Research (WRAIR)

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP