24768
document
Safety and immunogenicity of IMVAMUNE , a promising candidate as a third generation smallpox vaccine . A Phase I trial was performed to investigate the safety and immunogenicity of the third generation smallpox vaccine MVA-BN ( IMVAMUNE ) , a highly attenuated clone derived from the Modified Vaccinia Virus Ankara strain 571 , in naive and pre-immunized subjects . A total of 86 healthy subjects received the vaccine in five groups using different doses and routes of administration . All 38 subjects seroconverted in the groups receiving the highest dose ( 10 ( 8 ) TCID50 ) . All vaccinations were well tolerated with mainly mild or moderate pain at the injection site being the most frequent symptom . The results indicate that MVA-BN has the potential to be developed as an efficient and safe alternative to the conventional smallpox vaccines such as Lister-Elstree or Dryvax . Unique attributes render it a promising candidate for prophylactic mass immunization , even in subjects for whom conventional smallpox vaccines are contraindicated .
24769
Intervention_Pharmacological
IMVAMUNE
24770
Intervention_Physical
third generation smallpox vaccine MVA-BN ( IMVAMUNE )
24771
Intervention_Pharmacological
vaccine
24772
Intervention_Pharmacological
Lister-Elstree or Dryvax .
24773
Outcome_Other
Safety
24774
Outcome_Physical
immunogenicity
24775
Outcome_Other
safety
24776
Outcome_Other
immunogenicity
24777
Outcome_Other
well tolerated
24778
Outcome_Adverse-effects
mild or
24779
Outcome_Pain
moderate pain
24780
Outcome_Adverse-effects
at the injection site
24781
Outcome_Other
efficient and safe
24782
Participant_Condition
naive and pre-immunized subjects
24783
Participant_Sample-size
86
24784
Participant_Condition
healthy