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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02562482 |
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Date of registration:
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21/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
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Scientific title:
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Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults |
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Date of first enrolment:
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November 18, 2015 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02562482 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Dominican Republic
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Guadeloupe
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Haiti
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Martinique
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Puerto Rico
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Contacts
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Name:
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Clemente Diaz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Puerto Rico Clinical and Translational Research Consortium |
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Name:
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Jean W Pape, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centres GHESKIO, Haiti |
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Name:
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Andre Cabie, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire (CHU), Martinique |
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Name:
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Yeycy Donastorg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Dermatológico y Cirugía de Piel |
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Name:
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Nicolas Rosario, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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San Juan Hospital |
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Name:
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Bruno Hoen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Pointe-a-Pitre, Guadeloupe |
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Name:
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Grace Chen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VRC, NIAID, NIH |
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Name:
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Julie Ledgerwood, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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VRC, NIAID, NIH |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chikungunya Virus Infection
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Intervention(s)
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Other: VRC-PBSPLA043-00-VP
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Biological: VRC-CHKVLP059-00-VP
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Primary Outcome(s)
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Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection
[Time Frame: 7 days after any injection]
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
[Time Frame: Through study completion, an average of 72 weeks after first injection]
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Number of Subjects With an Abnormal Laboratory Result
[Time Frame: 4 weeks after last injection]
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Number of Subjects Reporting Serious Adverse Events (SAEs)
[Time Frame: Through study completion, an average of 72 weeks after first injection]
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Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection
[Time Frame: 7 days after any injection]
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Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events
[Time Frame: Through study completion, an average of 72 weeks after first injection]
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Secondary Outcome(s)
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Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population
[Time Frame: Week 8]
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Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat
[Time Frame: 4 weeks after last study injection]
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Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population
[Time Frame: Week 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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