An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1
نویسندگان
چکیده
This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection.
منابع مشابه
Expression of the Herpes Simplex Virus Type 2 Glycoprotein D in Baculovirus Expression System and Evaluation of Its Immunogenicity in Guinea Pigs
Background: Herpes simplex virus type 2 (HSV-2) is highly prevalent and major cause of genital herpes in humans. The life-long nature of infection and the increasing prevalence of genital herpes imply that vaccination is the best strategy for controlling the spread of infection and limiting HSV disease. HSV glycoprotein D (gD) is one of the most important viral immunogen which has an essential ...
متن کاملConstruction of an Eukaryotic Expression Vector Encoding Herpes Simplex Virus Type 2 Glycoprotein D and In Vitro Expression of the Desired Protein
To construct of an eukaryotic expression vector encoding herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2), an Iranian isolate of HSV-2 was propagated in HeLa cell line and its DNA was extracted and used as template in polymerase chain reactions (PCR), to amplify gD2 gene. Primers were designed and the restriction enzyme sites for EcoRI and XhoI were considered at their 5′ ends respectiv...
متن کاملAn Endogenous Immune Adjuvant Released by Necrotic Cells for Enhancement of DNA Vaccine Potency
Background: Improving vaccine potency in the induction of a strong cell-mediated cytotoxicity can enhance the efficacy of vaccines. Necrotic cells and the supernatant of necrotic tumor cells are attractive adjuvants, on account of their ability to recruit antigen-presenting cells to the site of antigen synthesis as well as its ability to stimulate the maturation of dendritic cells. Objective: T...
متن کاملتاثیر ادجوانتی یک وهله فعالیت ورزشی استقامتی با شدت متوسط در واکسیناسیون ویروس هرپس سیمپلکس 1 و یادآورهای آن بر سطوح اینترلوکین 10 و گرانزیم B در مدل موش
Background: The herpes simplex viruses cause a variety of clinical illnesses that are painful and often distressing. To control the infection, the development of an effective vaccine that prevents or reduces the primary and recurrent infections would be of great significance. With considering to immunological changes following an acute endurance exercise, the purpose of this study was to assess...
متن کاملThe Changing Epidemiology of Herpes Simplex Virus Type 1 Infection: The Associated Effects on the Incidence of Ocular Herpes
Herpes simplex virus type 1 (HSV-1) with a worldwide distribution has been reported in all human populations, resulting in a clinical spectrum of infections. Although HSV type 2 (HSV-2) is known as the most common cause of genital herpes, an increasing number of cases with genital herpes are caused by HSV-1. The present study aimed to discuss the changes in the epidemiology of HSV-1 infection i...
متن کامل