NCT00082069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

April 28, 2004

Last Update Submit

April 28, 2015

Conditions

Diarrhea

Keywords

Shigelladiarrhea

Outcome Measures

Primary Outcomes (3)

  • Safety

  • Mucosal immune response

  • Systemic immune response

Interventions

Shigella flexneri 2a Invaplex 50BIOLOGICAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be in very good health.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

  • 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.

    PMID: 20619378DERIVED

MeSH Terms

Conditions

DiarrheaDysentery, Bacillary

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsDysenteryGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • David Tribble, MD, PhD

    Naval Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2004

First Posted

April 30, 2004

Study Start

April 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

US(1)