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

This is an interventional other trial for Mosquito-Borne Disease focused on measuring Mosquito-Borne Diseases, Universal Mosquito Vaccine, Mosquito Transmission, Vector Borne Viruses, Vaccine Read More

-INCLUSION CRITERIA:

1. Healthy women and men who are greater than or equal to 18 and less than or equal to 50 years of age.
2. Willingness to complete all study visits and comply with all study requirements.
3. 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.

4. 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.
5. Willing to have samples stored for future research (including genetic research).
6. Agrees to abstain from alcohol intake for 24 hours prior to each study visit.
7. Agrees to not donate blood or blood products throughout the study.

EXCLUSION CRITERIA:

1. Participant has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the participation in the study.
2. Individual with body mass index (BMI) less than or equal to 18 and greater than or equal to 40.
3. 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.
4. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
5. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
6. Receipt of any unlicensed vaccine within 6 months prior to enrollment.
7. 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
8. 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.
9. History of a previous severe allergic reaction with generalized urticaria, angioedema, anaphylaxis or anaphylactoid reaction.
10. 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.
11. Has a known allergy to any of the components of the vaccine.
12. Has a history of severe immunization reaction.
13. Has a severe allergic reaction to mosquito bites