Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine
Condition: Mosquito-Borne Disease
MeSH terms: Vector Borne Diseases
Intervention: AGS-v; AGS-v + adjuvant; Placebo
Intervention description: AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21; ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21; WFI (0.5mL) on Day 0 and Day 21
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mosquito-Borne Diseases; Universal Mosquito Vaccine; Mosquito Transmission; Vector Borne Viruses; Vaccine

Summary:

      Background:

      Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v
      vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne
      diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.

      Objective:

      To see if the AGS-v vaccine is safe in humans and how it affects the immune system.

      Eligibility:

      Healthy adults ages 18-50

      Design:

      Participants will be screened another study.

      Participants will be randomly assigned to get either the vaccine with a booster vaccine, the
      vaccine without the booster, or a placebo. These are given through a needle in the upper arm.

      Participants will have visits that include medical history, physical exam, and blood and
      urine tests:

      Baseline: They will get the vaccine and be monitored for 2 hours.

      Follow-up visits 1 and 2 weeks after baseline.

      Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.

      Follow-up visits 1 and 2 weeks after booster visit.

      Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the
      lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the
      feeding.

      Phone follow-up a few days after the mosquito feeding.

      After the feeding visit, 5 follow-up visits about every 2 months

      Participants will keep a symptom diary for 7 days after each vaccine. They will record their
      temperature. They will measure any redness around the injection site. They will document and
      if possible photograph any mosquito bites they get.
    

Eligibility criteria:

        -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