Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine

-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 subject 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 4) 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 prior to study initiation through 12 weeks after the second vaccine administration. Acceptable methods of contraception include 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 <1%; 4) oral contraceptives; and 5) double barrier method including diaphragm.
• Willing to have samples stored for future research (including genetic research).
• Agrees to abstain from alcohol intake for 24 hours prior to each study visit.
• Agrees to not donate blood or blood products throughout the study.

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) baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
• Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
• Receipt of any unlicensed vaccine within 6 months prior to enrollment.
• Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine/serum test for drugs of abuse at screening
• Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI 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, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent.
• Has a known allergy to any of the components of the vaccine.
• Has a history of severe immunization reaction.
• Has a severe allergic reaction to mosquito bites