DR3 DataRelease
Release Date: 08/01/2013
| SDY78: Antigenic and immunogenic properties of recombinant hemagglutinin proteins when produced in various protein expression systems | |||||||||
| Status: | New | ||||||||
| Description: | Assess the immunogenicity and antigenicity of recombinant hemagglutinin proteins produced and purified by various methods | ||||||||
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| DOI: | 10.21430/M3EER1F151 | ||||||||
| Subjects: | 178 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY97: CD4 T cell response to pH1N1 vaccination | |||||||||
| Status: | New | ||||||||
| Description: | Healthy adult human subjects were given monovalent inactivated pH1N1 vaccine and antibody responses were assessed using HAI and MN assays. CD4 T cell reactivity was examined using IFNg Elispot assays to look at reactivity to unique and conserved peptide pools. | ||||||||
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| DOI: | 10.21430/M3PHW2D08D | ||||||||
| Subjects: | 49 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY208: Serological Memory and Long-term Protection to Novel H1N1 Influenza Virus After Skin Vaccination | |||||||||||
| Status: | New | ||||||||||
| Description: | Investigating the long-lived immunity and improved protection after skin vaccination | ||||||||||
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| DOI: | 10.21430/M3VGBJC7TC | ||||||||||
| Subjects: | 7 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||||||||
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| DOI: | 10.21430/M37NGTHMDS | ||||||||||||
| Subjects: | 91 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY215: TIV 2008 vaccination of CD95-/- mice and ELISA for detection of influenza-specific antibodies | |||||||
| Status: | New | ||||||
| Description: | Evaluation of the mouse immune response to influenza vaccination. ELISA was used to examine the immune response of mutant mice (MRL/Mpj-Faslpr/J (Mpj/lpr), B6.MRL-Faslpr/J (B6/lpr), MRL/MpJ (Mpj) and C57BL/6L (B6)) to a single dose of the trivalent 2008 seasonal influenza vaccine | ||||||
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| DOI: | 10.21430/M38JPMTP8S | ||||||
| Subjects: | 17 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY218: Oral Immunotherapy for Childhood Egg Allergy | ||||||||||
| Status: | New | |||||||||
| Description: | In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time. This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC). For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg. Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur. |
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| DOI: | 10.21430/M3Q2O0X9Z5 | |||||||||
| Subjects: | 55 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY24: Genetic Associations in subjects of anthrax trial [Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction (AVA000)] | |||||||
| Status: | Updated | ||||||
| Description: | AVA000 is an ongoing 43-month prospective, randomized, double-blinded, placebo controlled comparison of AVA administered either SQ or IM in up to 8 doses (licensed regimen) or as few as 4 doses. From inception the trial has been on schedule in enrolling 1,560 healthy adults (as of 07/2003, 1480 subjects) at 5 clinical sites in the US, randomized into six study groups with 260 per group. Group 1 receives the licensed regimen (8 doses, SQ), and groups 2-5 receive 4-8 doses, IM. Group 6 receives placebo, either SQ or IM. For immunogenicity analysis, blood samples are obtained from all subjects at enrollment, then prior to and 4 weeks after each injection (except at week 2). Levels of AbPA are measured in all subjects at all time points. A functional in vitro toxin (PA) neutralization assay is also performed on a subset of serum samples. For reactogenicity analysis, all adverse events, including local reactions at the injection sites, are actively monitored with both subject diaries and objective assessments by research study staff. |
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| DOI: | 10.21430/M3TT5SPDGV | ||||||
| Subjects: | 1563 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY25: Genotyping and gene function in healthy volunteers | |||||||
| Status: | Updated | ||||||
| Description: | The goal of this study is to create a pool of potential subjects genotyped in a manner identical to that used in the AVA000 trial population. Subjects were screened for exclusion based on history of chronic infectious or immune diseases and to avoid sampling during current acute infection. Genotyping data are available for reference purposes. The subjects agreed to be available to be recalled for sampling of blood for ex vivo studies of differential immunologic function of genetic variants corresponding to those associated with variation in vaccine response. |
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| DOI: | 10.21430/M3L5GO913J | ||||||
| Subjects: | 1423 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY28: Humoral and Cell-Mediated Immune Responses to Vaccinia Virus Immunization | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Our broad objective is to examine the role of candidate human immune response gene polymorphisms (and their receptors, expression and function) in inter-individual variability in vaccinia vaccine-induced humoral and cell-mediated immune responses among a cohort of 1,000 recently vaccinated subjects. In Research Area 1, we propose to study associations between specific class I and II HLA alleles (HLA-A, -B, -C, -DRB, -DQA, -DQB, -DPA, -DPB), specific cytokine genes, polymorphisms of the above cytokine receptors, a genome-wide SNP analysis; and variations in immune response to smallpox vaccine. In Research Area 2, we focus on identifying associations between expression and function of these same candidate genes likely to regulate immune response variations and humoral and cell-mediated immune responses following smallpox vaccination in selected human subjects. Both gene products (i.e., secreted proteins), cell surface expression, and measures of gene regulation/activation will be pursued. We focus on gene families involved in initiating, sustaining and regulating innate and adaptive immune responses, as well as those directly involved in directing specific antibody and cytotoxic T cell responses. |
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| DOI: | 10.21430/M3K3UZWK6S | ||||||||||||
| Subjects: | 1092 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY61: Systems Biology of 2007 Influenza Vaccination in Humans (See companion studies SDY269 2008 / SDY270 2009 / SDY271 Role for CaMKIV in the Regulation of Antibody Responses to Influenza Vaccine) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Using a systems biology approach to study innate and adaptive responses to influenza vaccination in humans during the 2007-2008 influenza season. | ||||||||||
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| DOI: | 10.21430/M3FH0SA2W0 | ||||||||||
| Subjects: | 12 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY62: Vaccination with drifted variants of H5 hemagglutinin protein elicits a broadened antibody response | |||||||
| Status: | Updated | ||||||
| Description: | Substantial H5 influenza HA directed immunity is elicited after vaccination of human subjects who had been previously immunized with a drifted H5 HA variant. We sought to investigate the characteristics of H5 HA specific immune responses in more depth by developing an animal model of H5 HA vaccination using drift variants of recombinant H5 HA proteins. HA proteins derived from influenzas A/Vietnam/1203/04 (Clade 1) and A/Indonesia/05/05 (Clade 2.1) were chosen. The sequence of vaccination consisted of two doses of homologous protein, followed by one additional dose of the homologous or heterologous, drifted HA protein. Each dose of HA was combined with CpG as an adjuvant and was injected subcutaneously. All the animals exhibited a serum IgG antibody response that cross-reacted with both HAs in an ELISA. However, those animals that received the drifted variant exhibited higher reactivity to the heterologous HA. Competitive ELISA of serum from drift-variant recipients showed evidence of antibody focusing towards the drifted HA, suggesting modification of the response towards improved cross-reactivity, though development of neutralizing antibodies was limited. Nevertheless, animals were protected against live-virus challenge, and passive transfer of serum was sufficient to confer protection to otherwise naive mice, indicating that both neutralizing and non-neutralizing antibodies offer some degree of protection. These findings suggest that pre-vaccination against H5 influenza has the potential to prime immunity against emerging drifted H5 strains, and could also lower the dose requirements of vaccination in the event of a pandemic. | ||||||
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| DOI: | 10.21430/M3RH4FT7XC | ||||||
| Subjects: | 86 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY162: Immunologic and genomic signatures of response to Hepatitis C Virus infection. | |||||||
| Status: | Updated | ||||||
| Description: | Examine the immune response in primary immune cells from subjects who have spontaneously cleared HCV compared to HCV chronically infected subjects | ||||||
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| DOI: | 10.21430/M3TI5NZ7VL | ||||||
| Subjects: | 20 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY167: VRC304 - A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP) Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | The primary objective was to evaluate the safety and tolerability of an investigational vaccine VRC-AVIDNA036-00-VP in humans at doses 1 mg and 4 mg administered intramuscularly using a needle-free injection system. The secondary objectives included evaluation of whether VRC-AVIDNA036-00-VP (at doses 1 mg and 4 mg) induced antibodies as assessed by an HAI assay at Day 0 and Week 12. Exploratory analyses included evaluation of the immunogenicity of VRC-AVIDNA036-00-VP at doses 1 mg and 4 mg using intracellular cytokine staining, ELISpot, neutralizing antibody assay, HAI assay to H1 or H3HA or other immunological assays at time intervals between Day 0 and Week 42. | ||||||||||||
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| DOI: | 10.21430/M3SGHW16WZ | ||||||||||||
| Subjects: | 45 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||