NCT01122784

Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The objectives of this trial are: to compare the safety of rF1V vaccine administered in two different schedules through 28 days after each vaccination and cumulatively to Day 210; to compare the immunogenicity of rF1V vaccine administered in two different schedules through 28 days after Vaccination 3; to compare the safety and immunogenicity of rF1V vaccine administered by two different schedules through 12 months after Vaccination 3; and to assess the contribution of the adjuvant to the immunogenicity of the rF1V antigen.

Conditions

• Plague Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	rF1V vaccine (with Adjuvant)	80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
BIOLOGICAL	rF1V vaccine (without Adjuvant)	80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
BIOLOGICAL	rF1V vaccine (with Adjuvant)	80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
BIOLOGICAL	rF1V vaccine (without Adjuvant)	80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2010-05-13
• Last updated: 2020-07-30

Locations

11 sites across 1 country: United States