Immunogenicity and Safety of Subunit Plague Vaccine
Condition: Plague
MeSH terms: Plague
Study type: Interventional
Phase: Phase 2

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 description: 
      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).
    

Intervention name(s): Plague vaccine
Intervention type(s): Biological
Intervention description(s): Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Plague vaccine; Immunogenicity; Safety