safety, reactogenicity and immunogenicity of a venezuelan equine encephalitis dna vaccine candidate administered by jet injection

Conditions: Vaccine Reaction

Summary: the goal of this clinical trial is to evaluate the safety and reactogenicity of a vee dna vaccine candidate delivered by either intramuscular or intradermal jet injection. the main question it aims to answer is: • is the vee dna vaccine candidate safe participants will: * receive the vee dna vaccine candidate by either intramuscular or intradermal jet injection * provide blood and urine samples * complete ecgs * complete physical exams * complete diaries


Eligibility criteria:
inclusion criteria: * healthy adults, male or female. * ages at least 18 at the start of the study and no greater than 49 years of age on day 1 of vaccination. * participants must be available for all visits and for the complete duration of the study. * participants must, in the opinion of the investigator or person obtaining consent, understand the information provided and be capable of providing informed consent. * women of child bearing potential (wocbp) must have a negative pregnancy test and be willing to use an effective method of contraception: oral contraception, diaphragm, cervical cap, intrauterine device, condom, or be anatomically sterile (in self or partner) from the date of screening until at least 6 months after the last vaccination. * if subject is a sexually active male, must be willing to use an effective method of contraception (such as condoms or be anatomically sterile) from screening until 6 months after the last vaccination. exclusion criteria: * clinically relevant abnormality on history or examination including a history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered to be significant by the designated trial physician in the last 6 months. * any acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation. * any of the following laboratory parameters with abnormal values that are moderate in severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, ast, alt). * if female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination. * receipt of a blood transfusion or blood products 6 months prior to enrollment. * participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study. * history of severe local or systemic reactions to vaccination or a history of severe allergic reactions. * history of guillain-barre syndrome. * confirmed diagnosis of hbv infection (surface antigen positive, hbsag); hepatitis c infection (hcv ab positive); hiv infection, or active syphilis. * history of grand mal epilepsy, or currently taking anti-epileptics. * any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection. * abnormal ecg finding that, in the opinion of the investigator, excludes the subject from participating. * history of syncope or history of a fainting episode within one year of study entry. * extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles). * presence of any surgical/traumatic metal implants, or significant scar tissue that may impair appropriate injection at the eligible sites of administration (skin or muscle of the upper left and right deltoid muscles). * in the opinion of the investigator, is unlikely to comply with the protocol. * as confirmed/reported by the study subject, a history of: exposure to venezuelan equine encephalitis virus (veev) or related alphavirus; prior immunization with an alphavirus replicon-based vaccine; prior immunization with a live-attenuated alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine. * a history of encephalitis as confirmed/reported by the study subject. * prior immunization against veev or related alphavirus or encephalitis, as confirmed/reported by the study subject. * history of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse (excluding marijuana) or addiction within 12 months of screening. * involved in the planning or conduct of the study.