A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Condition: Chikungunya Virus
MeSH terms: Chikungunya Fever
Intervention: CHIKV VLP, adjuvanted
Intervention description: Adjuvanted formulation includes aluminum hydroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Open Label Safety and Immunogenicity
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to assess the safety and immunogenicity of PXVX0317
      (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able and willing to provide informed consent voluntarily signed by participant.

          2. Any gender, 18 to 45 years of age (inclusive).

          3. Generally healthy, in the opinion of the Investigator, based on medical history,
             physical examination, and screening laboratory assessments.

          4. Women who are either:

             (i). Not of childbearing potential (CBP): pre-menarche, anatomically sterile, or
             post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the
             following criteria: Negative urine pregnancy test at screening visit; and Negative
             urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable
             method of contraception (if female of childbearing potential) for the duration of
             participation, such as: Hormonal contraceptives (e.g., implants, pills, patches)
             initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days
             prior to dosing or; double barrier type of birth control (male condom with female
             diaphragm, male condom with cervical cap).

        Exclusion Criteria:

          1. Currently pregnant, breastfeeding, or planning to become pregnant during the study.

          2. Body Mass Index (BMI) ≥35 kg/m2.

          3. Positive laboratory evidence of current infection with human immunodeficiency virus
             (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).

          4. History of severe allergic reaction or anaphylaxis to any component of the
             investigational product (IP).

          5. History of known congenital or acquired immunodeficiency that could impact response to
             vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic
             asplenia, alcoholic cirrhosis).

          6. Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six
             months prior to screening through Day 64.

          7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior
             to screening through Day 64.

          8. Acute disease within the last 14 days (participants with an acute mild febrile illness
             can be considered for a deferral of vaccination two weeks after the illness has
             resolved and treatment has been completed).

          9. Clinically significant cardiac, pulmonary, respiratory, rheumatologic, or other
             chronic disease, in the opinion of the Investigator. This may include chronic illness
             requiring hospitalization in the last one month prior to screening.

         10. Enrollment in an interventional study and/or receipt of another investigational
             product from 30 days prior to screening through the duration of study participation.

         11. Receipt or anticipated receipt of any vaccine from 30 days prior to screening through
             Day 64.

         12. Prior receipt of an investigational CHIKV vaccine/product.

         13. Detectable baseline anti-CHIKV IgG antibody as determined by ELISA.

         14. Any other condition that, in the opinion of the investigator, could adversely impact
             the participant's participation or the conduct of the study, creates an unacceptable
             risk to the participant, or may interfere with the conduct of the study or validity of
             the data.

         15. Restricted venous access that would prevent the collection of plasma and serum
             necessary for participation.

         16. Weight <110 pounds.