Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins
CHIKIVIG-01
Prevention of Chikungunya Infection in Neonates: Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins
2 other identifiers
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedNovember 3, 2014
August 1, 2014
1.1 years
August 28, 2014
October 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
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.
30 days
Secondary Outcomes (1)
Efficacy
30 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Written informed consent signed by both neonate's parents (or legal guardians).
- 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.
- Preterm neonate below 28 weeks of gestational age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Centre Hospitalier de la Basse-Terre
Basse-Terre, Guadeloupe, 97109, France
Centre Hospitalier de Cayenne "Andrée ROSEMON"
Cayenne, Guyane, 97306, France
CHU de Martinique
Fort-de-France, Martinique, 97261, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno HOEN, Professor
Centre Hospitalier Universitaire de Pointe-à-Pitre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 3, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2015
Study Completion
April 1, 2016
Last Updated
November 3, 2014
Record last verified: 2014-08