A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine...
Yellow FeverYellow Fever ImmunisationThis study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by s ubcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN.
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Dengue FeverDengue Hemorrhagic Fever1 moreThe aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue. Primary Objective: To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Secondary Objectives: To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue. To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Observational Objective: To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously...
Dengue FeverDengue Hemorrhagic FeverThe aim of the study was to assess and describe the booster effect of a tetravalent CYD dengue vaccine dose administered about 5 years or more after the completion of a 3-dose vaccination schedule in Singapore. Primary Objective: To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GMTRs) of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). Secondary Objectives: If the primary objective of non-inferiority achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in participants who received three doses of the CYD dengue vaccine in the CYD28 trial in all participants. To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28 participants) and immediately prior to booster or placebo injection in all participants. To describe the neutralizing antibody persistence 6 months, 1 year and 2 years post booster or placebo injection in all study participants. To evaluate the safety of booster vaccination with CYD dengue vaccine in all participants.
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
FeverAnticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents. The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia...
Febrile NeutropeniaThe purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.
Understanding Typhoid Disease After Vaccination
Typhoid FeverEnteric Fever1 moreUsing an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents...
DengueDengue Hemorrhagic Fever2 morePrimary objectives: To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Dengue FeverDengue Hemorrhagic Fever2 morePrimary Objectives: To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years...
Dengue VirusDengue Fever2 moreThe aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
Various G-CSF Regimens to Prevent Infection During Chemotherapy
Breast CancerChemotherapy1 moreThe purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia. Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia. The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear. So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis.