Track topics on Twitter Track topics that are important to you
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.
Invasive Gram negative bacterial infection resulting in sepsis continues to command substantial morbidity and mortality despite effective antibiotics and modern intensive care. It has been estimated that there are 300,000 cases per year in the United States. The emergence of multiple antibiotic resistant strains of bacteria adds to the urgency of finding novel therapies for the treatment of gram negative sepsis. Sepsis is a systemic inflammatory condition characterized by fever, hypotension, tachypnea, and tachycardia which can lead to multiple organ/system failure and ultimately death. This study is a randomized, partial blinded, placebo-controlled phase I safety and immunogenicity study in healthy subjects of detoxified J5 core glycolipid/ group B meningococcal outer membrane protein vaccine for gram-negative bacterial sepsis administered with and without synthetic unmethylated cytosine-guanosine motif (CPG) oligodeoxynucleotide 7909 adjuvant. The primary objective of this study is to establish the safety and tolerability of the combination of vaccine and CPG 7909. The secondary objective of this study is to determine if the combination of vaccine with the CPG 7909 is more immunogenic than vaccine alone. One dosage level of vaccine based on lipopolysaccharide (LPS) content will be studied in a three-dose regimen administered intramuscularly (IM). Since prior experience indicates no significant differences in immunogenicity response between the 10 and 25 microgram (mcg) doses of vaccine, researchers will test the 10 mcg dose. Researchers will also use 2 different doses of the CPG 7909 adjuvant (500 mcg and 250 mcg). There will be a control group that receives normal saline (NS) alone (placebo). The purpose of this study is to assess whether or not this vaccine is safe and well tolerated when given with an adjuvant, CPG 7909. The other goal of this study is to ascertain whether or not the combination of vaccine and adjuvant induces a more robust antibody response to the vaccine than is observed with the vaccine alone. The study population will include approximately 28-34 healthy subjects ages 18-50 years, inclusive, recruited from existing pool of Center for Vaccine Development (CVD) subjects. Subjects will be randomized to one of four study groups: (Group 1) 10 mcg vaccine alone; (Group 2) 10 mcg vaccine plus 500 mcg CPG 7909; (Group 3) 10 mcg vaccine plus 250 mcg CPG 7909; and (Group 4) placebo (normal saline). After blood is obtained for pre-vaccination antibody levels, subjects will receive 3 vaccinations at Day 0, 29 and 59. Subjects will be followed for safety (both clinical signs and symptoms and laboratory tests) and antibody response (anti-core glycolipid antibody by enzyme linked immunosorbent assay [ELISA], and opsonophagocytic response). Assessments for reactogenicity will be done for 30 minutes post vaccination and on the first and second days after each vaccination at the CVD and via 8 day memory aid, to be completed by the subject, after each vaccination. An electrocardiogram (EKG) will be performed after each vaccination. Blood sampling will be performed on Days 0, 14, 36, 66, 120, 180, and 365 to measure the immunogenicity of the vaccine with and without adjuvant and for antibody screening. A safety evaluation will be done by telephone on Day 90, Day 150 and Day 239, and a final safety antibody and immunogenicity evaluation will be done during the clinic visit at Day 365.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
CpG 7909, J5-OMP Vaccine, Placebo
University of Maryland Baltimore
Not yet recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:12:09-0400
The purpose of this study is to determine the safety of and immune response to a preventive malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare response...
The purposes of this study are to determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable immune response; to determine the safety of this vac...
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is a...
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be inclu...
Modified Vaccinia Ankara (MVA) is a live, viral vaccine under advanced development as a non-replicating smallpox vaccine. A randomised, double-blind, placebo-controlled phase III clinical trial was co...
Better tools are necessary to eliminate visceral leishmaniasis (VL). Modeling studies for regional Leishmania elimination indicate that an effective vaccine is a critical tool. Dogs are the reservoir ...
Despite progress in antiretroviral therapy, pre-exposure prophylaxis, microbicides, and other preventive strategies, a vaccine to prevent HIV-1 infection remains desperately needed. Development of an ...
Safety, tolerability and immunogenicity of the ExPEC4V (JNJ-63871860) vaccine for prevention of invasive Extraintestinal pathogenic Escherichia coli disease: a phase 1, randomized, double-blind, placebo-controlled study in healthy Japanese participants.
This Phase 1, randomized, double-blind, placebo-controlled study was conducted to evaluate the safety, tolerability and immunogenicity of different doses of ExPEC4V conjugate vaccine (4-16µg Polysacc...
The impact of dupilumab, an anti-interleukin (IL)-4Rα antibody that inhibits IL-4/IL-13 signaling, on vaccine responses in atopic dermatitis (AD) patients is unknown.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.
A systemic infection of various salmonid and a few nonsalmonid fishes caused by Viral hemorrhagic septicemia virus (see NOVIRHABDOVIRUS),
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...