VaricellaNCT00338442
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
A study testing VariZIG™ in people with Varicella, run by Cangene Corporation.
Trial summary
This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent.
- Cangene Corporation VariZIG™ release requirement.
- Any of the following at-risk patients exposed to varicella within the previous 96 hours:
- Immunocompromised pediatric or adult patients.
- Neonates (less than 1 year of age) and pre-term infants.
- Pregnant women.
- Newborns whose mothers had VZV infection shortly before delivery (< 5 days) or after (< 2 days) delivery.
- Healthy non-immune adults
Who cannot join
- Hypersensitivity to blood or blood products, including intravenous (IV) or intramuscular (IM) human immunoglobulin preparations.
- Selective immunoglobulin A (IgA) deficiency.
- Evidence of VZV infection.
- Evidence of zoster infection.
- Known immunity to VZV(previous varicella infection or varicella vaccination)
- Severely thrombocytopenic ( platelets < 50 x 10x9 / L )
About this study
This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.
Read the detailed description
In most individuals, chicken pox or varicella zoster (VZV) infections are benign; however, in certain at-risk populations such as immunocompromised patients or infants VZV disease can produce significant morbidity and mortality. In such patients, varicella zoster immune globulin (VZIG) has been used to prevent or reduce the severity of VZV infections in at-risk patients exposed to individuals with active infections. Massachusetts Public Health Biologic Laboratories (Boston, MA) has discontinued manufacture of the only FDA approved VZIG product. Cangene Corporation (Winnipeg, Canada) is conducting this expanded access IND protocol for VariZIG™, which is a purified human immune globulin preparation made from plasma of donors with high anti-varicella antibody titers.
This study is an open label, non-randomized, expanded access study that will make VariZIG™ available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted. The study will begin recruiting in February 2006 and will collect safety and basic efficacy data over 42 days following VariZIG™ administration. Physicians will be required to assess measures of varicella infection as well as provide study specific documentation.
- Conditions
- Varicella
- Being tested
- VariZIG™
- Keywords
- Immune compromised, Varicella Zoster Virus ( VZV) Infection, Pediatric
- Medical subject headings
- Chickenpox, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VariZIG™Drug
Biological / Vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VaricellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cangene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Gale, MD, Principal investigator, FFF Enterprises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338442
- Sponsor's protocol ID
- VZ-009
- Status last verified
- Apr 2013
- First submitted
- 15 Jun 2006
- Last updated
- 4 Apr 2013
- Results posted
- No
Publications
Gans H, Chemaly RF. Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program. BMC Infect Dis. 2021 Jan 11;21(1):46. doi: 10.1186/s12879-020-05656-6.
PubMed 33430796Duchon JM, Levin MJ, Gershon AA. Safety and Varicella Outcomes in In Utero-Exposed Newborns and Preterm Infants Treated With Varicella Zoster Immune Globulin (VARIZIG): A Subgroup Analysis of an Expanded-Access Program. J Pediatric Infect Dis Soc. 2020 Sep 17;9(4):449-453. doi: 10.1093/jpids/piz070.
PubMed 31774916
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
- ClinicalTrials.gov ID
- NCT00338442
- Acronym / sponsor ID
- VZ-009
- Conditions
- Varicella
- Keywords
- Immune compromised, Varicella Zoster Virus ( VZV) Infection, Pediatric
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Cangene CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.
Detailed description
In most individuals, chicken pox or varicella zoster (VZV) infections are benign; however, in certain at-risk populations such as immunocompromised patients or infants VZV disease can produce significant morbidity and mortality. In such patients, varicella zoster immune globulin (VZIG) has been used to prevent or reduce the severity of VZV infections in at-risk patients exposed to individuals with active infections. Massachusetts Public Health Biologic Laboratories (Boston, MA) has discontinued manufacture of the only FDA approved VZIG product. Cangene Corporation (Winnipeg, Canada) is conducting this expanded access IND protocol for VariZIG™, which is a purified human immune globulin preparation made from plasma of donors with high anti-varicella antibody titers.
This study is an open label, non-randomized, expanded access study that will make VariZIG™ available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted. The study will begin recruiting in February 2006 and will collect safety and basic efficacy data over 42 days following VariZIG™ administration. Physicians will be required to assess measures of varicella infection as well as provide study specific documentation.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent.
- Cangene Corporation VariZIG™ release requirement.
- Any of the following at-risk patients exposed to varicella within the previous 96 hours:
Key exclusion criteria (6 listed)
- Hypersensitivity to blood or blood products, including intravenous (IV) or intramuscular (IM) human immunoglobulin preparations.
- Selective immunoglobulin A (IgA) deficiency.
- Evidence of VZV infection.
- Evidence of zoster infection.
- Known immunity to VZV(previous varicella infection or varicella vaccination)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VariZIG™Biological / Vaccine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Derived from this study: PubMed 33430796Gans H, Chemaly RF. Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program. BMC Infect Dis. 2021 Jan 11;21(1):46. doi: 10.1186/s12879-020-05656-6.
- Derived from this study: PubMed 31774916Duchon JM, Levin MJ, Gershon AA. Safety and Varicella Outcomes in In Utero-Exposed Newborns and Preterm Infants Treated With Varicella Zoster Immune Globulin (VARIZIG): A Subgroup Analysis of an Expanded-Access Program. J Pediatric Infect Dis Soc. 2020 Sep 17;9(4):449-453. doi: 10.1093/jpids/piz070.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gale, MD principal investigator
FFF Enterprises
Questions about this trial
What is this clinical trial studying?
A study testing VariZIG™ in people with Varicella, run by Cangene Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338442, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.