Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

This is an interventional prevention trial for Mosquito-Borne Infectious Diseases Read More

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.