Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Intervention: VRC-CHKVLP059-00-VP; VRC-PBSPLA043-00-VP
Intervention description: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).; VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antibody Response; Immune Response; Healthy Volunteer; Vaccine-Mediated Protection; Chikungunya Virus; Vaccines, Virus-like Particles

Summary:

      This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the
      safety and immunogenicity of a 2-injection vaccine Chikungunya virus (CHIKV) virus-like
      particle vaccine (CHIKV VLP) in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject must meet all of the following criteria:

          -  18 to 60 years old

          -  Available for clinical follow-up through Study Week 72

          -  Able to provide proof of identity to the satisfaction of the study clinician
             completing the enrollment process

          -  Able and willing to complete the informed consent process

          -  Willing to donate blood for sample storage to be used for future research

          -  In good general health, with a body mass index (BMI)≤40, without clinically
             significant medical history, and has satisfactorily completed screening

          -  Physical examination and laboratory results without clinically significant findings
             within the 56 days prior to enrollment

        Laboratory Criteria within 56 days prior to enrollment:

          -  Hemoglobin either within institutional normal limits or accompanied by site physician
             approval as consistent with healthy adult status

          -  White blood cells either within institutional normal range or accompanied by site
             physician approval as consistent with healthy adult status

          -  Platelets = 125,000 - 500,000/mm3

          -  Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal (ULN)

          -  Serum creatinine ≤ 1.1 x ULN based on site institutional normal range

          -  Negative result on a human immunodeficiency virus (HIV) test that meets local
             standards for identification of HIV infection

          -  Negative result on the Chikungunya virus (CHIKV) screening antibody assay.

        Criteria applicable to women of childbearing potential:

          -  Negative human chorionic gonadotropin pregnancy test (urine or serum) on day of
             enrollment

          -  Agree to use an effective means of birth control from 21 days prior to enrollment
             through 12 weeks after the last study injection

        Exclusion Criteria:

        A subject will be excluded if one or more of the following conditions apply:

        Women Specific:

        -Planning to become pregnant during the 16 weeks after enrollment in the study

        Subject has received any of the following substances:

          -  Systemic immunosuppressive medications within 2 weeks prior to enrollment

          -  Blood products within 16 weeks prior to enrollment

          -  Immunoglobulin within 8 weeks prior to enrollment

          -  Prior vaccinations with an investigational CHIKV vaccine

          -  Investigational research agents within 4 weeks prior to enrollment

          -  Any vaccination within 2 weeks prior to enrollment

          -  Current anti-tuberculosis (TB) prophylaxis or therapy

        Subject has a history of any of the following clinically significant conditions:

          -  A history of immune-mediated or clinically significant arthritis

          -  Serious reactions to vaccines that preclude receipt of study injections as determined
             by the investigator

          -  Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema

          -  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

          -  Diabetes mellitus (type I or II), with the exception of gestational diabetes

          -  Idiopathic urticaria within the past year

          -  Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or
             platelet disorder requiring special precautions) or significant bruising or bleeding
             difficulties with intramuscular (IM) injections or blood draws

          -  Malignancy that is active or history of a malignancy that is likely to recur during
             the period of the study

          -  Seizure in the past 3 years or treatment for a seizure disorder within the last 3
             years

          -  Asplenia, functional asplenia or any condition resulting in the absence or removal of
             the spleen

          -  Psychiatric condition that may preclude compliance with the protocol; past or present
             psychoses; or a history of suicide plan or attempt within the five years prior to
             enrollment

          -  Any medical or social condition that, in the judgment of the investigator, is a
             contraindication to protocol participation or impairs a volunteer's ability to give
             informed consent