1. Safety, bioavailability, and pharmacokinetics of VGX-1027-A novel oral anti-inflammatory drug in healthy human subjects.

    Clinical Pharmacology in Drug Development 5(2):91 (2016) PMID 27138022

    VGX-1027, a novel oral immune modulator, is under development for the treatment of rheumatoid arthritis. The safety, tolerability, and pharmacokinetics of single (1-800 mg) and multiple (40-400 mg) oral doses were evaluated in 2 clinical studies. The doses were well tolerated up to 800 mg in a s...
  2. A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3).

    Gynecologic Oncology 140(2):245 (2016) PMID 26616223 PMCID PMC4724445

    The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3. Eligible patients with HPV16(+) CIN2...
  3. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial.

    The Lancet 386(10008):2078 (2015) PMID 26386540 PMCID PMC4888059

    Despite preventive vaccines for oncogenic human papillomaviruses (HPVs), cervical intraepithelial neoplasia (CIN) is common, and current treatments are ablative and can lead to long-term reproductive morbidity. We assessed whether VGX-3100, synthetic plasmids targeting HPV-16 and HPV-18 E6 and E...
  4. Synthetic consensus HIV-1 DNA induces potent cellular immune responses and synthesis of granzyme B, perforin in HIV infected individuals.

    Molecular Therapy 23(3):591 (2015) PMID 25531694 PMCID PMC4351468

    This study evaluated the safety and immunogenicity of PENNVAX-B in 12 HIV infected individuals. PENNVAX-B is a combination of three optimized synthetic plasmids encoding for multiclade HIV Gag and Pol and a consensus CladeB Env delivered by electroporation. HIV infected individuals whose virus w...
  5. Arthralgia among women taking aromatase inhibitors: is there a shared inflammatory mechanism with co-morbid fatigue and insomnia?

    Breast Cancer Research (Online Edition) 17(1):89 (2015) PMID 26126656 PMCID PMC4504449

    Arthralgia is a common toxicity among women taking aromatase inhibitors (AIs) and can lead to premature discontinuation of therapy. We evaluated the association between arthralgia, co-morbid fatigue and/or insomnia, and inflammatory biomarkers among women taking AIs. Women taking AIs for early-s...
  6. Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study.

    Endoscopy 46(2):127 (2014) PMID 24477368

    Endoscopic papillectomy of early tumors of the ampulla of Vater is an alternative to surgery. This large prospective multicenter study was aimed at evaluating the long-term results of endoscopic papillectomy. Between September 2003 and January 2006, 10 centers included all patients referred for ...
  7. A prospective study of chemotherapy immunologic effects and predictors of humoral influenza vaccine responses in a pediatric oncology cohort.

    Influenza and Other Respiratory Viruses 7(6):1158 (2013) PMID 23199016 PMCID PMC4634289

    Pediatric oncology patients represent a cohort of individuals uniquely at risk of complications from influenza, yet less likely to respond to the vaccine. It is not yet clear how to best protect this vulnerable population. We performed a prospective analysis of 177 pediatric oncology patients to...
  8. Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery.

    Journal of Infectious Diseases 208(5):818 (2013) PMID 23840043 PMCID PMC3733506

    DNA vaccines have been very poorly immunogenic in humans but have been an effective priming modality in prime-boost regimens. Methods to increase the immunogenicity of DNA vaccines are needed. HIV Vaccine Trials Network (HVTN) studies 070 and 080 were multicenter, randomized, clinical trials. Th...
  9. Pancreatoscopy-guided intracorporeal laser lithotripsy for difficult pancreatic duct stones: a case series with prospective follow-up (with video).

    Gastrointestinal Endoscopy 78(1):179 (2013) PMID 23540440

  10. Therapeutic and prophylactic DNA vaccines for HIV-1.

    Expert Opinion in Biological Therapy 13(4):563 (2013) PMID 23477730

    DNA vaccines have moved into clinical trials in several fields and their success will be important for licensure of this vaccine modality. An effective vaccine for HIV-1 remains elusive and the development of one is troubled by safety and efficacy issues. Additionally, the ability for an HIV-1 v...
  11. Antiviral effects of autologous CD4 T cells genetically modified with a conditionally replicating lentiviral vector expressing long antisense to HIV.

    Blood 121(9):1524 (2013) PMID 23264589 PMCID PMC3587318

    We report the safety and tolerability of 87 infusions of lentiviral vector–modified autologous CD4 T cells (VRX496-T; trade name, Lexgenleucel-T) in 17 HIV patients with well-controlled viremia. Antiviral effects were studied during analytic treatment interruption in a subset of 13 patients. VRX...
  12. Rituximab-treated patients have a poor response to influenza vaccination.

    Journal of Clinical Immunology 33(2):388 (2013) PMID 23064976 PMCID PMC3565069

    The efficacy of influenza vaccination in patients treated with rituximab is a clinically important question. Rheumatology clinics are populated with patients receiving rituximab for a broad array of disorders. Although several studies have explored the efficacy of other vaccines in rituximab-tre...
  13. Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial.

    Annals of Internal Medicine 158(1):19 (2013) PMID 23277897

    HIV-infected persons have less robust antibody responses to influenza vaccines. To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants. Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846) The MacGregor Clin...
  14. Effects of behavioral stress reduction Transcendental Meditation intervention in persons with HIV.

    AIDS Care 25(10):1291 (2013) PMID 23394825 PMCID PMC3659206

    Stress is implicated in the pathogenesis and progression of HIV. The Transcendental Meditation (TM) is a behavioral stress reduction program that incorporates mind-body approach, and has demonstrated effectiveness in improving outcomes via stress reduction. We evaluated the feasibility of implem...
  15. Immunologic consequences of chemotherapy for acute myeloid leukemia.

    Journal of Pediatric Hematology/Oncology 35(1):46 (2013) PMID 23018569 PMCID PMC3526680

    There are few data characterizing the immunologic consequences of chemotherapy for acute myeloid leukemia (AML) and almost nothing is known about the effects of chemotherapy in a pediatric AML cohort. We identified T-cell subsets, B-cell subsets, and used Enzyme-linked immunosorbent spot analyse...
  16. Adoptive transfer of autologous T cells improves T-cell repertoire diversity and long-term B-cell function in pediatric patients with neuroblastoma.

    Clinical Cancer Research 18(24):6732 (2012) PMID 23092876

    Children with high-risk neuroblastoma have a poor prognosis with chemotherapy alone, and hematopoietic stem cell transplantation offers improved survival. As a dose-escalation strategy, tandem transplants have been used, but are associated with persistent immunocompromise. This study evaluated t...
  17. Phase I/II randomized trial of dendritic cell vaccination with or without cyclophosphamide for consolidation therapy of advanced ovarian cancer in first or second remission.

    Cancer Immunology, Immunotherapy 61(5):629 (2012) PMID 22021066

    In spite of increased rates of complete response to initial chemotherapy, most patients with advanced ovarian cancer relapse and succumb to progressive disease. Immunotherapy may have potential for consolidation therapy. This randomized open-label phase I/II trial evaluated responses of patients...
  18. A prospective study of influenza vaccination and a comparison of immunologic parameters in children and adults with chromosome 22q11.2 deletion syndrome (digeorge syndrome/velocardiofacial syndrome).

    Journal of Clinical Immunology 31(6):927 (2011) PMID 21863400

    Prior to the advent of cardiac bypass, most children with congenital cardiac anomalies and chromosome 22q11.2 deletion syndrome died. With improved technology, there is now a wave of young adults with chromosome 22q11.2 deletion syndrome requiring clinical care. Fifteen young children and 20 adu...
  19. Transfer of influenza vaccine-primed costimulated autologous T cells after stem cell transplantation for multiple myeloma leads to reconstitution of influenza immunity: results of a randomized clinical trial.

    Blood 117(1):63 (2011) PMID 20864577 PMCID PMC3037760

    Severe immune deficiency follows autologous stem cell transplantation for multiple myeloma and is associated with significant infectious morbidity. This study was designed to evaluate the utility of a pretransplantation vaccine and infusion of a primed autologous T-cell product in stimulating sp...
  20. Long-term programming of antigen-specific immunity from gene expression signatures in the PBMC of rhesus macaques immunized with an SIV DNA vaccine.

    PLoS ONE 6(6):e19681 (2011) PMID 21701683 PMCID PMC3119060

    While HIV-1-specific cellular immunity is thought to be critical for the suppression of viral replication, the correlates of protection have not yet been determined. Rhesus macaques (RM) are an important animal model for the study and development of vaccines against HIV/AIDS. Our laboratory has ...