Invaplex 50 Vaccine Dose-Ranging - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diarrhea	Biological: Shigella flexneri 2a Invaplex 50	Phase I

MedlinePlus related topics:

Diarrhea

U.S. FDA Resources

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

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

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

Safety
Mucosal immune response
Systemic immune response

Estimated Enrollment:	32
Study Start Date:	April 2004
Estimated Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082069

Locations


United States, Maryland
	Walter Reed Army Institute of Research
	Silver Spring, Maryland, United States, 20910

Sponsors and Collaborators

U.S. Army Office of the Surgeon General

Investigators


Principal Investigator:	David Tribble, MD, PhD	Naval Medical Research Center

More Information

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

Study ID Numbers:	NMRC 2003.0008, WRAIR 1085, HSRRB A-12528, Invaplex50
First Received:	April 28, 2004
Last Updated:	November 1, 2006
ClinicalTrials.gov Identifier:	NCT00082069
Health Authority:	United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

Shigella

diarrhea

Study placed in the following topic categories:

Signs and Symptoms

Diarrhea

Signs and Symptoms, Digestive

Shigellosis

Dysentery, Bacillary

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	U.S. Army Office of the Surgeon General
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00082069