Herpes ZosterPhase 1/2NCT01213810
Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study
A Phase 1/2 study testing Zostavax in people with Herpes Zoster, run by University of Zurich.
Trial summary
The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status. Trial with medicinal product Trial with immunomodulatory product / biological Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Zostavax
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Male, or female with negative urine pregnancy test
- VZV-seropositive (serologically documented)
- Agree to use a barrier method of birth control (such as a condom)
- Written informed consent HIV positive individuals on ART (group A1-A3)
- Continuous ART for >3 months before baseline
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- No change of ART regimen within 1 month before baseline
- HIV-RNA (value must be <3 months old )<50 copies/ml at last visit
- CD4-count (value must be <3 months old) > 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3
- Participation in the SHCS HIV-positive individuals without ART (group B)
- HIV-1 RNA >1000 copies/ml (<3 months before baseline)
- CD4-cell count >500 cells/µl (<3 months before baseline)
- Participation in the SHCS Healthy HIV-negative volunteers (group C)
- Negative HIV-screening test (<3 months before baseline)
- CD4 cell count >500 cells/µl
Who cannot join
- Contraindications on ethical grounds
- Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
- Pregnancy or breast feeding.
- Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
- Known or suspected non-compliance, drug- or alcohol abuse.
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- Specific exclusion criteria
- Fever > 38.3 °C or acute illness during the last 4 weeks
- Exposure to chickenpox or shingles within four weeks prior to study entry
- History of shingles
- Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids)
- Household contact with known immunodeficiency (e.g. HIV-positive with CD4 <250 cells/µl)
- Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination
- Previous allergic reaction to vaccine components (i.e. neomycin or gelatin)
- Vaccination with a life attenuated vaccine one month prior to study entry
- History of chickenpox vaccination
- Treatment with anti-herpes drugs 4 weeks before baseline
- Severe coagulation disorder or oral anticoagulant treatment
- Laboratory exclusion criteria.
- Thrombocytopenia < 50x 103/?l
- Haemoglobin <12 g/dl
- More than threefold elevation of ALT
- Creatinine of more than150 µmol/l
- Glucose >10 mmol/l
About this study
The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status.
- Trial with medicinal product
- Trial with immunomodulatory product / biological
- Conditions
- Herpes Zoster
- Being tested
- Zostavax
- Keywords
- HIV, VZV (Varicella zoster Virus), vaccine, T cell, immunogenicity, safety
- Medical subject headings
- Herpes Zoster, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZostavaxBiological
Biological/Vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Geometric mean titer of Varicella zoster virus-specific IgG, VZV-specific T- cells per 106 peripheral mononuclear cells, Frequency of VZV-specific T- cells of total T-cells, CD4+ T-cells in different HIV-positive persons.
Measured: half a year
Safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Hasse, MD, Principal investigator, University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213810
- Sponsor's protocol ID
- SHCS 610
- Status last verified
- Feb 2013
- First submitted
- 13 Aug 2010
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study
- ClinicalTrials.gov ID
- NCT01213810
- Acronym / sponsor ID
- SHCS 610
- Conditions
- Herpes Zoster
- Keywords
- HIV, VZV (Varicella zoster Virus), vaccine, T cell, immunogenicity, safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 4 Oct 2010 (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.
The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status.
- Trial with medicinal product
- Trial with immunomodulatory product / biological
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >18 years
- Male, or female with negative urine pregnancy test
- VZV-seropositive (serologically documented)
- Agree to use a barrier method of birth control (such as a condom)
- Written informed consent HIV positive individuals on ART (group A1-A3)
Key exclusion criteria (24 listed)
- Contraindications on ethical grounds
- Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
- Pregnancy or breast feeding.
- Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
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 |
|---|---|---|
| ZostavaxBiological/Vaccine | Biological | – |
Primary outcome
Immunogenicity
Time frame: half a year
Geometric mean titer of Varicella zoster virus-specific IgG, VZV-specific T- cells per 106 peripheral mononuclear cells, Frequency of VZV-specific T- cells of total T-cells, CD4+ T-cells in different HIV-positive persons.
Safety
Time frame: half a year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
Barbara Hasse, MD principal investigator
University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zostavax in people with Herpes Zoster, run by University of Zurich.
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 15 inclusion and 24 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: withdrawn, as of the sponsor's last update on 1 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Immunogenicity (time frame: half a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2013.