Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Sep 2023

At a glance

  • Drugs VRC-CHKVLP059-00-VP (Primary)
  • Indications Chikungunya virus infections
  • Focus Adverse reactions
  • Most Recent Events

    • 08 Sep 2023 Results of a post hoc analysis comparing safety and immunogenicity of CHIKV VLP vaccine in seropositive (n = 39) versus seronegative (n = 155) vaccine recipients for 72 weeks post-vaccination published in the Vaccine
    • 26 May 2021 Results published in the Media Release
    • 14 Apr 2020 Results published in the JAMA: the Journal of the American Medical Association.

Trial Overview

Purpose

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.

Primary Endpoints

Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection

description: Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
time_frame: 7 days after any injection

Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection

description: Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
time_frame: 7 days after any injection

Number of Subjects With an Abnormal Laboratory Result

description: Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56.
time_frame: 4 weeks after last injection

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

description: Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for "Any AE" is the number of subjects reporting at least one or more AEs.
time_frame: Through study completion, an average of 72 weeks after first injection

Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events

description: Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks.
time_frame: Through study completion, an average of 72 weeks after first injection

Other Endpoints

Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population

description: Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
time_frame: Week 8

Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population

description: Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
time_frame: Week 8

Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat

description: Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
time_frame: 4 weeks after last study injection [1]

Diseases Treated

Indication Qualifiers Patient Segments
Chikungunya virus infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 400

    Actual: 400

  • Sex male & female
  • Age Group 18-60 years (Mean age = 35 years); adult

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT02562482 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-003556-44 European Clinical Trials Database
VRC704 -
IMEA048 -

Organisations

  • Affiliations Leidos Holdings; The EMMES Corporation

Trial Dates

  • Initiation Dates

    Actual : 18 Nov 2015

  • Primary Completion Dates

    Planned : 01 Oct 2018

    Actual : 06 Mar 2018

  • End Dates

    Planned : 01 Oct 2018

    Actual : 06 Mar 2018

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Dominican Republic; France; Guadeloupe; Haiti; Martinique; Puerto Rico
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
VRC-CHKVLP059-00-VPPrimary Drug Intramuscular Injection

Group 1: VRC-CHKVLP059-00-VP 20 mcg

Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). Biological: VRC-CHKVLP059-00-VP (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).)

Group 2: Placebo (VRC-PBSPLA043-00-VP)

Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). Other: VRC-PBSPLA043-00-VP (VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.)

Results

Publications

  1. Chen GL, Coates EE, Plummer SH, Carter CA, Berkowitz N, Conan-Cibotti M, et al. Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial. JAMA 2020;323(14):1369-1377.

    PubMed | CrossRef Fulltext
  2. McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, et al. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. . Vaccine 2023;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Andrews C 1 - -
Bailer RT 1 - -
Beck A 1 - -
Bedell L 1 - -
Berkowitz N 1 - -
Bray A 1 - -
Brockett B 1 - -
Cabie A 1 - -
Carlton K 1 - -
Carter CA 1 - -
Chen GL 2 1 -
Coates EE 2 - -
Conan-Cibotti M 1 - -
Cox JH 1 - -
Diaz C 1 - -
Donastorg Y 1 - -
Dowd KA 1 - -
Gall J 1 - -
Gordon D 1 - -
Gordon IJ 1 - -
Graham BS 1 - -
Haney D 1 - -
Hoen B 1 - -
Kaltovich F 1 - -
Koup RA 1 - -
Lampley R 1 - -
Larkin B 1 - -
Ledgerwood JE 2 - 1
Mascola JR 1 - -
May J 1 - -
McCarty JM 1 1 -
Mendy J 2 - -
O'Callahan M 1 - -
Pape JW 1 - -
Pierson TC 1 - -
Plummer SH 1 - -
Richardson JS 1 - 1
Rosario N 1 - -
Schwartz R 1 - -
Tredo SR 1 - -
Warfield KL 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Andre Cabie, MD Clinical Investigation Center of French West Indies and French Guiana Martinique
Bruno Hoen, MD University Hospital Pointe-a-Pitre, Guadeloupe
-
Clemente Diaz, MD Puerto Rico Clinical and Translational Reserach Consortium
-
Jean W Pape, MD GHESKIO, Haiti
-
Julie Ledgerwood, DO VRC, NIAID, NIH
-
Midnela Acevedo-Flores, MD San Juan Hospital
-
Study coordinator

Hopital Bichat Claude Bernard 46 rue Henri Huchard
PARIS
Postcode: 75018
France
Telephone: 33140256365
Fax: 33140256356
aida.benalycherif@gmail.com
show details
IMEA Fondation Leon Mba France
Yeycy Donastorg, MD Instituto Dermatológico y Cirugía de Piel Dominican-Republic

Centres

Centre Name Location Trial Centre Country
Centres GHESKIO Port Au Prince Haiti
Clinical Investigation Center of French West Indies and French Guiana Fort-de-France Martinique
FHI 360
-
-
GHESKIO, Haiti
-
-
IMEA Fondation Leon Mba PARIS France
Instituto Dermatológico y Cirugía de Piel Santo Domingo Dominican-Republic
Leidos
-
-
National Institute of Allergy and Infectious Diseases (NIAID)
-
-
Puerto Rico Clinical and Translational Research Consortium San Juan Puerto-Rico
Puerto Rico Clinical and Translational Reserach Consortium
-
-
San Juan Hospital
-
-
San Juan Hospital, Research Unit Rio Piedras Puerto-Rico
The EMMES Corporation
-
-
University Hospital of Pointe-à-Pitre Pointe A Pitre Guadeloupe
University Hospital Pointe-a-Pitre, Guadeloupe
-
-
VRC, NIAID, NIH
-
-

Trial History

Event Date Event Type Comment
08 Sep 2023 Results Results of a post hoc analysis comparing safety and immunogenicity of CHIKV VLP vaccine in seropositive (n = 39) versus seronegative (n = 155) vaccine recipients for 72 weeks post-vaccination published in the Vaccine Updated 14 Sep 2023
26 May 2021 Results Results published in the Media Release Updated 31 May 2021
29 Oct 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 29 Oct 2020
14 Apr 2020 Results Results published in the JAMA: the Journal of the American Medical Association. Updated 17 Apr 2020
25 Apr 2019 Status change - completed Status changed from active, no longer recruiting to completed. Updated 15 May 2019
27 Feb 2019 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2015-003556-44). Updated 27 Feb 2019
15 Jun 2018 Completion date Planned End Date changed from 1 Dec 2017 to 1 Oct 2018. Updated 25 Jun 2018
15 Jun 2018 Other trial event Planned primary completion date changed from 1 Sep 2017 to 1 Oct 2018. Updated 25 Jun 2018
18 Jan 2017 New trial record New trial record Updated 18 Jan 2017
23 Oct 2016 Status change - active, no longer recruiting Status has been changed from Recruiting to Active, no longer recruiting. Updated 20 Jan 2017

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2023;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  3. Chen GL, Coates EE, Plummer SH, Carter CA, Berkowitz N, Conan-Cibotti M, et al. Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial. JAMA 2020;323(14):1369-1377.

    PubMed | CrossRef Fulltext
  4. McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, et al. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. . Vaccine 2023;.

    PubMed | CrossRef Fulltext
Back to top