NCT00332956 is a Phase 2 clinical trial of rFIV vaccine in Healthy Volunteers, sponsored by DynPort Vaccine Company LLC, A GDIT Company.

Who is sponsoring NCT00332956?

NCT00332956 is sponsored by DynPort Vaccine Company LLC, A GDIT Company.

What drugs are being tested in NCT00332956?

Interventions in NCT00332956: rFIV vaccine, rF1V vaccine, rF1V vaccine, rF1V vaccine 160 mcg given on Study Days 0, 56, 182.

What condition does NCT00332956 study?

NCT00332956 studies Healthy Volunteers.

Is NCT00332956 still recruiting?

NCT00332956 is currently completed. Last updated 28 November 2011.

Last reviewed 2011-11-28 · How we verify

NCT00332956

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 (a), Dose-Blinded, Block-Randomized, Dose and Schedule Selection Study to Evaluate the Immunogenicity and Safety of the Recombinant Plague Vaccine rF1V in Healthy Volunteers

Completed Phase 2 Last updated 28 November 2011

What this trial tests

Phase 2 trial testing rFIV vaccine in Healthy Volunteers in 400 participants. Completed in 1 October 2008.

Timeline

1 May 2006

Primary endpoint
1 February 2008

1 October 2008

Quick facts

Lead sponsor	DynPort Vaccine Company LLC, A GDIT Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Enrollment	400
Start date	1 May 2006
Primary completion	1 February 2008
Estimated completion	1 October 2008
Sites	9 locations across United States

Drugs / interventions tested

rFIV vaccine — full drug profile →
rF1V vaccine — full drug profile →
rF1V vaccine — full drug profile →
rF1V vaccine 160 mcg given on Study Days 0, 56, 182 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

DynPort Vaccine Company LLC, A GDIT Company — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210
Time frame: Day 210 Interim Analysis

Sponsor's own description

This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies for biodefense.
Froude JW, Stiles B, Pelat T, Thullier P. · · 2011 · cited 46× · PMID 22123065 · DOI 10.4161/mabs.3.6.17621
<i>Yersinia pestis</i> and Plague: some knowns and unknowns.
Yang R, Atkinson S, Chen Z, Cui Y, et al · · 2023 · cited 29× · PMID 37602146 · DOI 10.15212/zoonoses-2022-0040
UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments.
Noad RJ, Simpson K, Fooks AR, Hewson R, et al · · 2019 · cited 23× · PMID 31522809 · DOI 10.1016/j.vaccine.2019.09.009
Biological threat preparedness through vaccine development and stockpiling: challenges and strategic implications.
Lee J. · · 2025 · cited 1× · PMID 40529698 · DOI 10.3389/fpubh.2025.1614626

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00332956 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by DynPort Vaccine Company LLC, A GDIT Company
Last refreshed: 28 November 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00332956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing