Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram-negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant
Terminated
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2011-11-01
The purpose of this study is to test the safety of an experimental vaccine against sepsis
(infection of the blood) alone and with an experimental adjuvant (a substance that may
improve vaccine effectiveness). This study will also find out how well antibodies are made
after receiving vaccine alone or vaccine combined with adjuvant. Participants will include up
to 34 healthy volunteers between the ages 18-50 years. Participants will be randomly assigned
to 1 of 4 groups to receive vaccine alone, vaccine with adjuvant (2 different dosages) or
placebo (inactive substance). Participants will receive 3 vaccinations at different times
during the study (Day 0, Day 29 and Day 59). Study procedures will include blood samples,
urine samples, electrocardiogram (measures heart activity) and a completion of a memory aid
to document side effects. Participation will involve 16 clinic visits and 3 follow-up
telephone calls over 12 months.
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
Completed
Public Health England
Phase 4
2013-09-01
The trial includes groups receiving various combinations of meningitis C and pertussis
containing vaccines, to be administered concomitantly in adolescents due their school leaving
booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age).
Immunogenicity and reactogenicity will be assessed.
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