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Invaplex 50 Vaccine Dose-Ranging

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00082069
First received: April 28, 2004
Last updated: January 7, 2010
Last verified: January 2010
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014