Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

Fecha de inicio: 8 de julio de 2019

Inclusion Criteria: * Healthy women and men who are greater than or equal to 18 and less than or equal to 50 years of age. * Willingness to complete all study visits and comply with all study requirements. * A male participant is eligible for the study if he agrees to practicing abstinence or using a condom with spermicide plus an acceptable form of contraception (see inclusion criteria below) being used by any female partner from 4 weeks before study start to 12 weeks after the second vaccine administration. * A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following: * Of non-child bearing potential (i.e., women who have had a hysterectomy or tubal ligation, or are postmenopausal, as defined by no menses in greater than or equal to 1 year). * Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks before study initiation and 12 weeks after the second vaccine administration. Acceptable methods of contraception include a female partner who is the sole sexual partner of the female participant, a male partner who is sterile and is the sole sexual partner of the female participant, or a male partner who uses a condom with spermicide plus 1 or more of the following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of less than 1%; 4) oral contraceptives; and 5) double barrier method including diaphragm. * Willing to have samples stored for future research. * Agrees to abstain from alcohol intake for 24 hours before each study visit. * Agrees to not donate blood or blood products throughout the study. * Score greater than or equal to 70% on comprehension quiz at screening Exclusion Criteria: * Participant has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the participation in the study. * Individual with body mass index (BMI) less than or equal to 18 and greater than or equal to 40. * Participants who have a clinically significant (as determined by the PI or designee) baseline Grade 1 or greater toxicity, or any Grade 2 or greater toxicity (regardless of clinical significance) by the toxicity table. * Receipt of blood or blood products including immunoglobulin within 3 months before enrollment. * Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) before enrollment. * Receipt of any unlicensed vaccine within 6 months before enrollment. * Participated in study NCT03055000 testing safety and immunogenicity of AGS-v. * Self-reported or known history of alcoholism or drug abuse within 6 months before enrollment. * Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI or designee to be a contraindication to protocol participation. * History of a previous severe allergic reaction with generalized urticaria, angioedema, anaphylaxis or anaphylactoid reaction. * Any condition or event that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent. * Known allergy to any vaccine component, including adjuvants. * History of severe immunization reaction. * Severe allergic reaction to mosquito bites (anaphylaxis) * Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days before study vaccination * Have taken high-dose inhaled corticosteroids\* within 30 days before each study vaccination (\* High-dose defined per age as using inhaled high dose per reference chart: https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthma\_qrg\_0\_0.pdf) * Received or plan to receive a licensed, live vaccine within 30 days before or after the study vaccination * Received or plan to receive a licensed, inactivated vaccine within 14 days before or after study vaccination * Serologic evidence of infection with HIV, hepatitis B virus, or hepatitis C virus * Ongoing chronic skin condition, or acute skin condition at the time of vaccination or mosquito feeding, except for mild eczema. * History of keloid formation after previous biopsies, lacerations, abrasions, surgeries, or other skin procedures (e.g., cosmetic piercings) that are deemed by the PI or designee to be a contraindication to protocol participation. * Pregnancy, breastfeeding, or planning to become pregnant up to one month after mosquito feeding.