Clinical Trial: Immunogenicity and Safety of Subunit Plague Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety of Subunit Plague Vaccine Comprised by Fraction 1 Capsule (F1) and Virulence-Associated (V) Antigens: A Random Phase 2a Clinical Trial

Brief Summary: Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis. Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history for plague as an agent of biowarfare, and poses a serious threat to international security. Althought the killed whole-cell plague vaccine and live attenuated vaccine have been licensed, they are rarely used today because of toxicities, limited evidence for efficacy to prevent plague, and limited commercial availability. In the last twenty years,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing greater protection than vaccines comprised of either subunit alone. This study was aimed to explor the safety and immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and recombined V antigen (F1+rV).

Detailed Summary: Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis, transmitted naturally from rodent reservoirs to humans via fleas. Human diseases may also result from contact with blood or tissues of infected animals or exposure to aerosolized droplets containing bacteria. Pneumonic plague is typically diagnosed in humans with with high mortality. It has a long history for plague as an agent of biowarfare, and poses a serious threat to international security. In human history, there were three outbreaks of plague all over the world, about 200 million people died from the disease. The increasing trend of plague epidemic in recent years, some regions and countries in the world still have the outbreak of the plague. It implies that safe and effective vaccine is urgently to developing. Althought the killed whole-cell plague vaccine and live attenuated vaccine have been licensed, these vaccines cause significant adverse reactions, including fever, headache, malaise, lymphadenopathy, erythema and induration at the injection site with high degree of immune variability. They are rarely used today because of toxicities, limited evidence for efficacy to prevent plague, and limited commercial availability. Based on the researches in the last twenty years,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing greater protection than vaccines comprised of either subunit alone. This study was aim to exploring the safety and immunogenicity of a new type plague subunit vaccine which comprised by native F1 antigen and recombined V antigen (F1+rV).
Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Current Primary Outcome:

  • To evaluate immunogenicity after vaccination. [ Time Frame: Day 28 post-dose 2 ]
    the GMT of antibodies to F1 antigen at day 28 post-dose2
  • Proportion of subjects reporting solicited adverse reactions. [ Time Frame: Day 7 post-each dose ]
    Proportion of subjects reporting solicited adverse events within 7 days post-each dose


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • GMI of antibodies to F1 antigen. [ Time Frame: Day 28 post-each dose ]
  • The seroconversion rate of antibodies to F1 antigen [ Time Frame: Day 28 post-each dose ]
  • GMT of antibodies to F1 antigen at day 28 [ Time Frame: Day 28 post- dose1 ]
  • GMT of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  • GMI of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  • The seroconversion rate of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  • Proportion of subjects reporting unsolicited adverse events [ Time Frame: Day 28 post-each dose ]
    Proportion of subjects reporting unsolicited adverse events within 28 days post-each dose
  • Proportion of subjects with serious adverse events (SAE)occurring throughout the trial [ Time Frame: Day 0 up to day 28 post-dose 2 ]
    Proportion of subjects with serious adverse events (SAE)occurring throughout the trial from day 0 to 56.


Original Secondary Outcome: Same as current

Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: November 2, 2015
Date Started: October 2014
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015