NCT01122784 is a Phase 2 clinical trial of rF1V vaccine (with Adjuvant) in Plague Vaccine, sponsored by DynPort Vaccine Company LLC, A GDIT Company.

Who is sponsoring NCT01122784?

NCT01122784 is sponsored by DynPort Vaccine Company LLC, A GDIT Company.

What drugs are being tested in NCT01122784?

Interventions in NCT01122784: rF1V vaccine (with Adjuvant), rF1V vaccine (without Adjuvant), rF1V vaccine (with Adjuvant), rF1V vaccine (without Adjuvant).

What condition does NCT01122784 study?

NCT01122784 studies Plague Vaccine.

Is NCT01122784 still recruiting?

NCT01122784 is currently completed. Last updated 28 July 2020.

Last reviewed 2020-07-28 · How we verify

NCT01122784

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

A Phase 2b Randomized, Single-Blinded Study to Evaluate the Safety and Immunogenicity of 80 µg Recombinant Plague Vaccine (rF1V) With and Without Adjuvant at Two Vaccination Schedules in Healthy Adult Volunteers

Completed Phase 2 Last updated 28 July 2020

What this trial tests

Phase 2 trial testing rF1V vaccine (with Adjuvant) in Plague Vaccine in 402 participants. Completed in 1 July 2012.

Timeline

1 July 2010

Primary endpoint
1 May 2012

1 July 2012

Quick facts

Lead sponsor	DynPort Vaccine Company LLC, A GDIT Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	402
Start date	1 July 2010
Primary completion	1 May 2012
Estimated completion	1 July 2012
Sites	11 locations across United States

Drugs / interventions tested

rF1V vaccine (with Adjuvant) — full drug profile →
rF1V vaccine (without Adjuvant) — full drug profile →
rF1V vaccine (with Adjuvant) — full drug profile →
rF1V vaccine (without Adjuvant) — full drug profile →

Conditions studied

Plague Vaccine — all drugs for Plague Vaccine →

Sponsor

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

Who can join

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

What's being measured

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

To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210.
Time frame: Day 210 for Cohorts 1 through 4

Sponsor's own description

Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).

Publications & conference data

2 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
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:

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 NCT01122784 (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 July 2020

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/NCT01122784.

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