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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

April 28, 2004
January 7, 2010
April 2004
November 2006   (final data collection date for primary outcome measure)
  • Safety
  • Mucosal immune response
  • Systemic immune response
Not Provided
Complete list of historical versions of study NCT00082069 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Invaplex 50 Vaccine Dose-Ranging
Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Diarrhea
Biological: Shigella flexneri 2a Invaplex 50
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082069
NMRC 2003.0008, WRAIR 1085, HSRRB A-12528, Invaplex50
Not Provided
Not Provided
U.S. Army Office of the Surgeon General
Not Provided
Principal Investigator: David Tribble, MD, PhD Naval Medical Research Center
Walter Reed Army Institute of Research (WRAIR)
January 2010

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