Invaplex 50 Vaccine Dose-Ranging

NCT ID: NCT00082069

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-11-30

Brief 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.

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.

Conditions

Diarrhea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Shigella flexneri 2a Invaplex 50

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Tribble, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Research Center

Locations

Walter Reed Army Institute of Research

Silver Spring, Maryland, United States

Countries

United States

References

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. doi: 10.1016/j.vaccine.2010.06.086. Epub 2010 Jul 7.

Reference Type: DERIVED

PMID: 20619378 (View on PubMed)

Other Identifiers

WRAIR 1085

Identifier Type: OTHER

Identifier Source: secondary_id

HSRRB A-12528

Identifier Type: OTHER

Identifier Source: secondary_id

NMRC 2003.0006

Identifier Type: -

Identifier Source: org_study_id