NCT00246467

One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)

A Phase 1b, Multi-Centre, Parallel Group, Single Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Plague Vaccine (rF1 and rV Antigens) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: PharmAthene UK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).

Detailed description

Plague is an infection occurring in small rodents and mammals caused by the gram-negative bacterium Yersinia pestis (Y. pestis). Transmission from rodent to man is usually by a flea vector leading to the characteristic swelling of the lymph nodes draining the region of the bite, followed by a septicaemic illness (classic bubonic plague). Human-to-human transmission can occur via droplet nuclei spread by coughing of patients with bubonic or septicaemic plague who have developed pulmonary lesions (pneumonic plague). However, cases of pulmonary transmission have also been described from household pets. In pneumonic plague symptoms of a respiratory infection develop first followed by an acute onset septicaemic illness. In the military context, the likely exposure is via the inhalation route, as a Biological Warfare Agent (BWA), and therefore protection against pneumonic plague is the paramount requirement. This is a phase 1, parallel group, single-blind study of 105 healthy adult aged 18-55, randomly assigned to one of the three cohorts and will receive the same dose of vaccines (2x) and then re-randomized at 6 months to receive either a third dose or placebo, in order to determine the safety and tolerability associated with different primary immunization doses of recombinant IM plague vaccine (rF1 and rV) antigen proteins for optimum safe dose, assess responses (both antibody and cell-mediated) following immunization, investigate the correlation between cell-mediated and antibody titers and to assess the duration of the immune responses to antigens following a third dose.

Conditions

• Plague

Interventions

Type	Name	Description
BIOLOGICAL	Alhydrogel
BIOLOGICAL	rF1 and rV protein antigens

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-10-31
• Last updated: 2008-09-15

Locations

10 sites across 2 countries: United States, United Kingdom