Invaplex 50 Vaccine Dose-Ranging

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082069
• Other study ID #: NMRC 2003.0006
• Secondary ID: WRAIR 1085HSRRB
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2004
• Last updated: April 28, 2015
• Start date: April 2004
• Est. completion date: November 2006

Study information

• Verified date: April 2015
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

Intervention

Biological:
• Shigella flexneri 2a Invaplex 50

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Mucosal immune response
Primary	Systemic immune response

External Links

•   Clinical Trials Center website