Invaplex 50 Vaccine Dose-Ranging - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Invaplex 50 vaccine

U.S. FDA Resources

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
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided by Walter Reed Army Institute of Research (WRAIR)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tribble D, Kaminski R, Cantrell J, Nelson M, Porter C, Baqar S, Williams C, Arora R, Saunders J, Ananthakrishnan M, Sanders J, Zaucha G, Turbyfill R, Oaks E. Safety and immunogenicity of a Shigella flexneri 2a Invaplex 50 intranasal vaccine in adult volunteers. Vaccine. 2010 Aug 23;28(37):6076-85. Epub 2010 Jul 7.

ClinicalTrials.gov Identifier:	NCT00082069 History of Changes
Other Study ID Numbers:	NMRC 2003.0008, WRAIR 1085, HSRRB A-12528, Invaplex50
Study First Received:	April 28, 2004
Last Updated:	January 7, 2010
Health Authority:	United States: Food and Drug Administration

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

Shigella
diarrhea

Additional relevant MeSH terms:

Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012