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Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins

NCT02230163 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-11-03

No results posted yet for this study

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.

Conditions

  • Chikungunya Virus Infection

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Guadeloupe

    lead OTHER

Principal Investigators

  • Bruno HOEN, Professor · Centre Hospitalier Universitaire de Pointe-à-Pitre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2016-04-30

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230163 on ClinicalTrials.gov