Chikungunya Virus Vaccine Trial in Healthy Adults
Condition: Viral Vaccines; Chikungunya Fever; Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Intervention: VRC-CHKVLP059-00-VP
Intervention description: VRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine-Mediated Protection; Antibody Response; Chikungunya Virus; Immune Response; Healthy Volunteer; Humoral Inmunity; Virus-like Particles

Summary:

      Background:

      - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache,
      muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint
      pain, which may be directly related to the infecting virus, may be severe and last for
      several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new
      experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy
      adults. Participants cannot develop CHIKV from this vaccine.

      Objectives:

      - To test the safety and effectiveness of a Chikungunya virus vaccine.

      Eligibility:

      - Healthy individuals between 18 and 50 years of age.

      Design:

        -  This study, including vaccine doses and followup tests, will last about 44 weeks.
           Participants will have three vaccination visits, six followup clinic visits, and three
           telephone contacts during this study. Vaccination visits will take about 4 hours. Most
           other clinic visits will usually take 2 hours. The telephone contacts will take about 15
           minutes.

        -  Participants will be screened with a physical exam and medical history. Blood samples
           will also be collected.

        -  Participants will be assigned to one of three dose groups. Information about doses will
           be provided before the start of the vaccinations.

        -  Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks.
           Participants will be asked to keep an eye on the injection site for 7 days and to notify
           researchers if there are any side effects.

        -  Participants will be monitored throughout the study with blood samples and clinic
           visits.
    

Eligibility criteria:

        INCLUSION CRITERIA:

        A participant must meet all of the following criteria:

          1. 18 to 50 years old

          2. Available for clinical follow-up through Week 44

          3. Able to provide proof of identity to the satisfaction of the study clinician
             completing the enrollment process

          4. Complete an Assessment of Understanding prior to enrollment and verbalize
             understanding of all questions answered incorrectly

          5. Able and willing to complete the informed consent process

          6. Willing to donate blood for sample storage to be used for future research

          7. In good general health, with a BMI less than or equal to 40, without clinically
             significant medical history, and has satisfactorily completed screening

          8. Physical examination and laboratory results without clinically significant findings
             within the 56 days prior to enrollment

             Laboratory Criteria within 56 days prior to enrollment:

          9. Hemoglobin greater than or equal to11.5 g/dL for women; greater than or equal to13.5
             g/dL for men

         10. WBC: 3,000-12,000 cells/mm(3).

         11. Differential either within institutional normal range or accompanied by physician
             approval

         12. Total lymphocyte count: greater than or equal to 800 cells/mm(3)

         13. Platelets = 125,000-500,000/mm(3)

         14. Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal
             range

         15. Serum creatinine less than or equal to1x upper limit of normal (less than or equal
             to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males).

         16. Negative FDA-approved HIV blood test

             Female-Specific Criteria

         17. Negative Beta-HCG pregnancy test (urine or serum) on day of enrollment for women
             presumed to be of reproductive potential

         18. A woman of childbearing potential must agree to use an effective means of birth
             control from at least 21 days prior to enrollment through 12 weeks after last study
             vaccination

        EXCLUSION CRITERIA:

        A participant will be excluded if one or more of the following conditions apply:

        Female-Specific Criteria

          1. Woman who is breast-feeding or planning to become pregnant during the time projected
             for individual study participation

          2. Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior
             to enrollment [with the exceptions that a short course of corticosteroids (less than
             or equal to10 days duration or a single injection) for a self-limited condition at
             least 2 weeks prior to enrollment will not exclude study participation]

          3. Blood products within 16 weeks prior to enrollment

          4. Immunoglobulin within 8 weeks prior to enrollment

          5. Prior vaccinations with an investigational CHIKV vaccine

          6. Investigational research agents within 4 weeks prior to enrollment

          7. Live attenuated vaccines within 4 weeks prior to enrollment

          8. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or
             allergy treatment with antigen injections, within 2 weeks prior to enrollment

          9. Current anti-TB prophylaxis or therapy

             Subject has a history of any of the following clinically significant conditions:

         10. A history of confirmed or suspected CHIKV infection

         11. A history of immune-mediated or clinically significant arthritis

         12. Serious reactions to vaccines that preclude receipt of study vaccinations as
             determined by the investigator

         13. Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of
             angioedema

         14. Asthma that is unstable or required emergent care, urgent care, hospitalization or
             intubation during the past two years or that is expected to require the use of oral or
             intravenous corticosteroids

         15. Diabetes mellitus (type I or II), with the exception of gestational diabetes

         16. Idiopathic urticaria within the past year

         17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or
             platelet disorder requiring special precautions) or significant bruising or bleeding
             difficulties with IM injections or blood draws

         18. Malignancy that is active, or treated malignancy for which there is not reasonable
             assurance of sustained cure, or malignancy that is likely to recur during the period
             of the study

         19. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol
             withdrawal more than 3 years ago, or 3) seizures that have not required treatment
             within the last 3 years

         20. Asplenia, functional asplenia or any condition resulting in the absence or removal of
             the spleen

         21. Psychiatric condition that may preclude compliance with the protocol; past or present
             psychoses; disorder requiring lithium; or within five years prior to enrollment, a
             history of suicide plan or attempt

         22. Any medical condition (such as thyroid disease or hypertension that are not well
             controlled by medication, or viral hepatitis) that, in the judgment of the
             investigator, is a contraindication to protocol participation or impairs a volunteer's
             ability to give informed consent