Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
Condition: Mosquito-Borne Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Vector Borne Diseases
Intervention: AGS-v PLUS Vaccine; Montanide ISA-51 Adjuvant; Alhydrogel® Adjuvant; Saline Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Aluminum Hydroxide; Monatide (IMS 3015)
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a
      universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
    

Eligibility criteria:

        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.