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Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.

ABSTRACT: HPV remains the most common sexually transmitted disease worldwide, despite improvements in awareness, screening, prophylactic vaccination uptake, and surgical treatment. VGX-3100 is an immunotherapy that uses electroporation to introduce DNA encoding for modified HPV-16 and HPV-18, E6-and E7 proteins into myocytes to stimulate an effector T cell response. We now report immunogenicity and safety of VGX-3100 for a refrigeration-stable formulation, which improves patient-care setting usability. This multi-arm, double-blinded, randomized trial enrolled 235 healthy men and women to receive either a refrigerated (RF) or frozen formulation (FF) of VGX-3100. Three doses were administered intramuscularly with electroporation at 0, 4, and 12 weeks. Non-inferiority of RF to FF was assessed by comparing the proportion of subjects who achieved a ?2-fold increase from baseline to Week 14 in Spot Forming Units/106 PMBCs using an interferon-? enzyme-linked immunospot assay. There were no related SAEs. Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration. The primary endpoint was met with 89.9% of RF recipients and 97.2% of FF recipients reaching a ?2-fold rise in SFU/106 PBMC, 2 weeks following the last dose; RF was statistically non-inferior to FF (p = .022). A systemic, immunologic approach has the potential to fill a critical gap in the ability to treat men and women with high grade HPV diseases. These safety and immunogenicity data are supportive of the continued development of a refrigerated formulation of VGX-3100.

SUBMITTER: Hollenberg RK

PROVIDER: S-EPMC7482708 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.

Hollenberg Rebecca K RK Krieger Diane R DR Samuels Robert R Kraynyak Kim K Sylvester Albert A Morrow Matthew M Boyer Jean J Dallas Michael M Bhuyan Prakash K PK

Human vaccines & immunotherapeutics 20191220 6

HPV remains the most common sexually transmitted disease worldwide, despite improvements in awareness, screening, prophylactic vaccination uptake, and surgical treatment. VGX-3100 is an immunotherapy that uses electroporation to introduce DNA encoding for modified HPV-16 and HPV-18, E6-and E7 proteins into myocytes to stimulate an effector T cell response. We now report immunogenicity and safety of VGX-3100 for a refrigeration-stable formulation, which improves patient-care setting usability. Th ...[more]

PMID: 31860383

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Project description:This paper describes and presents a stable and reliable set of stereo-photogrammetric normative data for global and spino-pelvic sagittal alignment, as a proven reference system for evaluating/measuring a fully unconstrained natural upright neutral standing attitude in a young healthy adult population. The methodological features described in this article will enable future studies to replicate and/or directly compare a wide range of different postural tests and/or sagittal alignment assessment procedures including the study of sagittal spine shape variations occurring during gait performance. To date, the quantitative evaluation of adult spinal deformity (ASD) has been mainly confined to the X-ray imaging approach and, more recently, to 3D X-ray reconstruction. Within the existing evaluation framework an opportunity exists for an additional approach: a quantitative evaluation procedure which is easy, accurate, relatively speedy and non-ionising, in order to monitor and track the progress of patients in the areas of both surgical and non-surgical treatment. The resources and methodology described in this paper have been proven to meet all these criteria. They have enabled full 3D posture (including 3D spine shape and sagittal alignment of the skeleton) to be consistently and successfully measured in adult volunteers. All the measurement/evaluation procedures and outcomes carried out were based entirely on the new non-ionising 3D opto-electronic stereo-photogrammetric approach described in this article. The protocol for this methodology was based on a standard set of 27 pre-selected anatomical "landmarks" on the human body, providing standard reference points for observation and measurement. A total of 124 healthy subjects were successfully assessed and, for each subject, 27 individual markers were applied to the corresponding locations on his/her body. Statistical tests to investigate gender differences were also carried out. Descriptive statistics are provided for all 15 of the spino-pelvic parameters under consideration. Results indicated significant differences between genders in five sets of parameters: Kyphosis tilt, Head tilt, Pelvic tilt, Spino-pelvic angle and T1-pelvic angle. The data also demonstrate a high degree of congruity with results obtained using the X-ray method, as evidenced by the existing literature in the field. In summary, the current study presents a new stereo-photogrammetric opto-electronic technology which can be used successfully for ASD evaluation and introduces a comprehensive set of normative data analogous to those proposed in X-ray analysis for sagittal spino-pelvic and total body alignment.

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Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.

Publications

Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.

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