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Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins (CHIKIVIG-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02230163
Recruitment Status : Unknown
Verified August 2014 by Centre Hospitalier Universitaire de Pointe-a-Pitre.
Recruitment status was:  Recruiting
First Posted : September 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Pointe-a-Pitre

Brief Summary:

Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several other Caribbean islands as well as French Guyana, South America. During the outbreak of Chikungunya that affected the Reunion island in 2005/2006, it was observed that the neonatal forms of infections acquired by mother to child transmission during childbirth, were not the exception and were critical. Mother-to-child transmission occurs when the mother is viremic at the time of delivery. The mean duration of viremia after the onset of first clinical symptoms is six days. The rate of mother-to-child transmission is 50%. All neonates contaminated during labor and delivery present with a symptomatic disease and the rate of severe forms is about 50%, primarily due to damage of the central nervous system, often leaving permanent damage (seizures, cerebral palsy).Due to the severity of Chikungunya in neonates and the burden of cerebral palsy, it is imperative to identify a safe and effective preventive and/or curative intervention. Human polyvalent immunoglobulins purified from plasma samples obtained from Chikungunya-convalescent donors exhibit a potent neutralizing activity in vitro. They were evaluated for their preventive and curative effects in a neonatal mouse model of CHIKV infection. After administration of a lethal dose of CHIKV, all neonatal mice that had received immunoglobulins survived while all control animals that had received non hyperimmune immunoglobulins died. In humans, specific human immunoglobulins proved to be effective and safe in neonates born to hepatitis B viremic mothers.

Hypothesis : The investigators hypothesize that the administration of anti-CHIKV hyperimmune human intravenous immunoglobulins to neonates exposed to a high risk of severe form of Chikungunya infection is safe enough to justify its evaluation in an open non randomized trial aimed to confirm the safety and preliminary assess the efficacy of this intervention.


Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Biological: anti-CHIKV hyperimmune immunoglobulins Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Chikungunya Infection in Neonates: Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins
Study Start Date : September 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya


Intervention Details:
  • Biological: anti-CHIKV hyperimmune immunoglobulins
    Anti-CHIKV immunoglobulins (CHIKVIg) were purified after the Tégéline manufacturing process from a pool of 583 plasma samples from donors in the convalescent phase of CHIKV infections. Anti-CHIKV hyper immune intravenous immunoglobulin (50 mg/ml) is prepared as a powder to be reconstituted. The therapeutic regimen will consist of 2 doses of 0.5 g/kg 12 hours apart.


Primary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]

    The primary endpoint will measure tolerability and safety of anti-CHIKV hyperimmune IVIG. It will be evaluated in all enrolled neonates and will be based on the occurrence of the following events:

    • patent ductus arteriosus,
    • ulceronecrotizing enterocolitis,
    • pulmonary hemorrhage,
    • tachycardia, hypotension, decreased O2 saturation during anti-CHIKV IVIG infusion,
    • hemolytic anemia,
    • fluid overload, as indicated by hyponatremia and/or ascites.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 30 days ]

    The following secondary endpoints will be evaluated only in neonates born to mothers who had a definite CHIKV-infection.

    Neonates will be classified in one of the following 3 categories:

    • Neonatal CHIKV clinical disease:

      • Clinical symptoms consistent with acute CHIKV infection
      • Demonstration of infection based on CHIKV IgM seroconversion and/or identification of CHIKV viremia (positive CHIKV qRT-PCR at Day 3),
    • Neonatal CHIKV asymptomatic infection:

      • Absence of any symptom consistent with CHIV infection
      • Demonstration of infection based on CHIKV IgM seroconversion and/or identification of CHIKV viremia (positive CHIKV qRT-PCR at Day 3),
    • Neonatal CHIKV infection excluded:

      • Absence of CHIKV IgM seroconversion.

    Below is an indicative list of symptoms that are consistent with Chikungunya infection in neonates:

    • Skin rash, severe desquamative disorder, bullous dermatitis,
    • Acral edema
    • Symptoms of encephalopathy/encephalitis : stupor, seizures, impaired sucking



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Inclusion criteria in mothers:

    • Clinical symptoms consistent with CHIKV infection (acute-onset high-grade fever combined with bilateral polyarthralgia and no other cause than Chikungunya) during the pre-partum period or within the 48 hours post-partum,
    • Written informed consent obtained,
    • Negative Dengue fever rapid diagnostic test,
    • Blood sampled for CHIKV RT-PCR, processed in emergency, to be used to define 3 diagnosis categories at neonate's birth:
    • positive: definite maternal CHIKV infection,
    • pending: probable maternal CHIKV infection,
    • negative: maternal CHIKV infection excluded.
  • 2. Inclusion criteria in neonates:

    • Neonate born to a mother fulfilling ALL maternal inclusion criteria and NO maternal exclusion criteria,
    • Written informed consent signed by both neonate's parents (or legal guardians).

Exclusion Criteria:

  • 1. Exclusion criteria in mothers:

    • Delivery more than 6 days after the onset of first symptoms of CHIKV infection,
    • Maternal CHIKV infection excluded,
    • Chronic active HBV infection (positive HBs Ag),
    • HIV infection.
  • 2. Exclusion criteria in neonates:

    • Preterm neonate below 28 weeks of gestational age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230163


Contacts
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Contact: Bruno HOEN, Professor 5 90 89 15 89 ext 33 bruno.hoen@chu-guadeloupe.fr
Contact: Marc LECUIT, Professor 1 40 61 30 29 ext 33 marc.lecuit@pasteur.fr

Locations
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France
Centre Hospitalier de la Basse-Terre Not yet recruiting
Basse-Terre, Guadeloupe, France, 97109
Contact: Gérard SIBILLE, Doctor    5 90 80 54 54 ext 33    gerard.sibille@ch-labasseterre.fr   
Contact: Jean-Christophe HEBERT, Doctor    5 90 80 54 54 ext 33    jean-christophe.hebert@ch-labasseterre.fr   
Centre Hospitalier de Cayenne "Andrée ROSEMON" Not yet recruiting
Cayenne, Guyane, France, 97306
Contact: Félix DJOSSOU, Dr    5 94 39 50 40 ext 33    felix.djossou@ch-cayenne.fr   
CHU de Martinique Recruiting
Fort-de-France, Martinique, France, 97261
Contact: André CABIE, Professor    5 96 55 23 01 ext 33    andre.cabie@chu-fortdefrance.fr   
Contact: Olivier FLECHELLES, Doctor    5 96 70 93 71 ext 33    olivier.flechelles@chu-fortdefrance.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre
Investigators
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Principal Investigator: Bruno HOEN, Professor Centre Hospitalier Universitaire de Pointe-à-Pitre

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Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
ClinicalTrials.gov Identifier: NCT02230163    
Other Study ID Numbers: RBM-PAP-2014/39
2014-001853-18 ( EudraCT Number )
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: August 2014
Keywords provided by Centre Hospitalier Universitaire de Pointe-a-Pitre:
Chikungunya virus
Human anti-CHIKV hyperimmune intravenous immunoglobulins
Neonates
Additional relevant MeSH terms:
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Infection
Chikungunya Fever
Virus Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs