Herpes ZosterPhase 1NCT01137669
ZOSTAVAX® in Renal Transplant Patients
A Phase 1 study testing Live attenuated herpes zoster vaccine in people with Herpes Zoster, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Live attenuated herpes zoster vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Feb 2015
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Subjects must be willing and able to provide informed consent prior to study procedures. -Age 18 years or older at the time of vaccination. -Chronic kidney disease (CKD) activated on the United Network for Organ Sharing (UNOS) deceased donor waitlist or anticipating living donor renal transplant no sooner than 4 weeks following vaccination. -Varicella Zoster Virus (VZV) seropositive by local laboratory or Center for Disease Control (CDC) serologic testing -Negative pregnancy test (women of childbearing age potential) performed at enrollment- or within 48 hours prior. The use of contraception for women of childbearing potential will be per renal transplant team's standard of care
Who cannot join
- -Any pharmacologic immunosuppression at the time of enrollment, within one year prior to enrollment, or between enrollment and transplant (e.g., for underlying autoimmune disease or previous failed allograft). This includes prednisone at >/= 0.3 mg/kg/day or steroid equivalent for > 10 days, any use of anti-metabolites (azathioprine, mycophenolic acid, cytoxan), leflunomide, TNF-alpha inhibitors, calcineurin inhibitors, mTOR inhibitors, IL-6 or IL-6 receptor inhibitors. -Any transplant other than solitary kidney (e.g., no kidney/pancreas, kidney/liver transplants). Second kidney transplants are permitted. -Anticipated use of any post-transplant experimental immunosuppressive agent -Prior ZOSTAVAX® or Varivax® vaccination -Shingles or any other herpes zoster within 12 months of planned vaccination -Receipt of any killed vaccines within 2 weeks prior and 4 weeks following study vaccination or receipt of any live vaccines within 4 weeks prior and 6 weeks following study vaccination -Intercurrent illness at time of planned vaccination -Inability to vaccinate in either arm (e.g. due to A-V fistula or graft) -Known Human immunodeficiency virus (HIV) infection, Hepatitis C virus (HCV) infection, or chronic hepatitis B determined from review of laboratory data obtained from pre-transplant evaluation by renal transplant team. Note positive IgG hepatitis B surface antibody alone (negative HBcAb and negative IgM) is indicative of vaccine induced immunity and is not grounds for exclusion -History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other components of the vaccine -Asthma requiring systemic or inhaled steroid treatment within 12 months prior to enrollment -Allergy to ganciclovir, valgancyclovir, acyclovir, or famciclovir -Panel Reactive Antibody (PRA) >/= 20 percent or donor-specific sensitization (by solid phase assay or flow cytometry) or treatment with intravenous immunoglobulin (IVIG) for desensitization prior to transplant -History of primary or acquired immunodeficiency states. -Routine use of anti-viral prophylaxis for Herpes Simplex Virus (HSV) at the time of vaccination or within 3 months prior -Any other condition that in the opinion of the investigator might interfere with the subject's safety or ability to participate in the study -Abnormal screening laboratory data resulting in a disqualification of transplant candidacy. Abnormalities due to underlying disease (e.g., renal failure, anemia, hyperlipidemia, cardiovascular disease, diabetes) are not exclusionary except as denoted above for HIV, hepatitis B, hepatitis C, autoimmune disease. -The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. -The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) psychiatric diagnosis identified at the pre-transplant evaluation. -The subject has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others identified at the pre-transplant evaluation. -Dual listing at more than one transplant center. -Unwilling to be temporarily inactivated on UNOS wait list for 4 weeks post vaccination.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore - School of Medicine - Medicine
Baltimore, Maryland, 21201-1509
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
Vanderbilt University - Medicine - Infectious Diseases
Nashville, Tennessee, 37232-2035
About this study
Official title: Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation
The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed persons and in the United States for individuals less than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive substance) no less than 4 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for up to 18 months.
Read the detailed description
Infection with varicella-zoster virus (VZV) produces a life-long latent infection in sensory ganglia. Reactivation of viral replication from latency results in a number of clinical syndromes, most commonly herpes zoster, or shingles. Herpes zoster is typically a unilateral vesicular rash in a dermatomal distribution accompanied by radicular pain that may be severe. Immunocompromised persons are at higher risk for herpes zoster than immunocompetent adults. The markedly increased risk of herpes zoster in organ transplant recipients suggests that this population would benefit substantially if a similar strategy could be adopted. The currently licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live), is not licensed for use in immunosuppressed persons and in the United States for those less than 50 years of age. A small Phase I study is important to address immunogenicity in patients with Chronic Kidney Disease (CKD) prior to transplantation as well as safety and persistence of immune responses following transplantation. This study is a multi-center, double blind, randomized, placebo-controlled trial of ZOSTAVAX® immunization in subjects who will undergo renal transplantation from a living donor or are wait-listed for a deceased donor no less than 4 weeks prior to transplantation. The primary objective of this study is to assess the safety of ZOSTAVAX® when administered to subjects with CKD a minimum of 4 weeks prior to live donor renal transplantation. This will be accomplished by comparing the rates of specific local and systemic reactogenicity events and adverse events (AEs) between the vaccine and placebo groups. Subjects likely to be suitable for renal transplant and who have an identified living donor will be consented for screening serology for antibodies to VZV if such serology is not standard of care or serostatus is not known. Subjects with positive VZV serology, an identified living donor, and meeting inclusion and exclusion criteria will provide signed informed consent for study enrollment. Subjects will be randomized to receive either active vaccine (ZOSTAVAX®) [30 subjects] or placebo vaccine [10 subjects]. Blood will be drawn on day 0 (day of vaccine) prior to vaccine administration for assessment of baseline humoral and cellular immunity to VZV. Subjects will receive ZOSTAVAX® or placebo vaccination. At approximately 5 weeks post-vaccination, subjects will have blood drawn for measurement of humoral and cellular immune response. Subjects will undergo living donor renal transplant with immunosuppression according to standard of care at each institution. All transplanted subjects will receive anti-viral prophylaxis for 3 months post-transplant, consisting of either valganciclovir (or ganciclovir) or acyclovir (or valacyclovir or famciclovir) depending on risk of cytomegalovirus (CMV) disease. Subjects will be followed and treated by the renal transplant team at each center according to local standard of care with concomitant monitoring by the vaccine study teams. Subjects will have blood drawn for humoral and cell-mediated immune assays at day 0, and week 5 post vaccination, and 6 months and 12 months post-transplantation if they undergo transplantation. Parent protocol to sub-study 09-0025.
- Conditions
- Herpes Zoster
- Being tested
- Live attenuated herpes zoster vaccine, Placebo
- Keywords
- immunocompromised,parent protocol,shingles,varicella-zoster virus,ZOSTAVAX®
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated herpes zoster vaccineBiological
ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation. The vaccine will be supplied in 3-mL glass vials. Sterile diluent will be used to reconstitute study vaccine. The reconstituted vial will be gently agitated to mix thoroughly. The entire contents of the reconstituted vaccine vial (approximately 0.65 mL) will be withdrawn into a syringe. The vaccine will be administered immediately subcutaneously in the deltoid region.
PlaceboOther
Placebo for Zoster Vaccine Live (ZOSTAVAX®) is sterile normal saline which will be obtained from the Fisher Repository in single-dose containers. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. The placebo will be administered subcutaneously in the deltoid region.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 10 subjects to receive placebo subcutaneously. Receives: Other: Placebo |
| ZOSTAVAX® | Experimental | 30 subjects to receive 0.65 mL ZOSTAVAX® subcutaneously. Receives: Biological: Live attenuated herpes zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy proven graft rejection
Measured: During 12 months post- vaccination or post- transplantation
Safety: any occurrence of proven [polymerase chain reaction (PCR) confirmed] vaccine strain varicella zoster virus (VZV) infection at any site not contiguous with the injection site.
Measured: Entire post-immunization period up to 12 months following transplantation.
Safety: incidence of grade 3 or higher vaccine related adverse events (AEs) and vaccine related serious adverse events (SAEs).
Measured: During the 4 weeks post-immunization.
Safety: incidence of vaccine related serious adverse events (SAEs).
Measured: During 12 months post- vaccination or post-transplantation
Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) after immunization in the absence of any other attributable cause.
Measured: Prior to vaccination, to following vaccination while on the wait list (for up to 12 months)
Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) prior to transplantation in the absence of any other attributable cause.
Measured: Study Day 0, through Study Day 35 post vaccination, or to the time of transplantation in those subjects who are transplanted. The ideal time for transplantation is 6 weeks post vaccination.
Secondary outcomes (2)
Immune response: changes from baseline glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) varicella zoster virus (VZV) antibody titer.
Measured: Approximately 5 weeks post immunization, 6 months and 12 months post-vaccination or 6 months and 12 months post-transplantation.If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional.
Immune response: changes from baseline number of VZV specific T cells by flow cytometry measuring intracellular interleukin-2 (IL-2), interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha after stimulation with VZV antigens.
Measured: Approximately 5 weeks post-immunization, 6 months and 12 months post-immunization or post-transplantation. If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2015
- Study completionFeb 2015
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137669
- Sponsor's protocol ID
- 09-0016
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2010
- Last updated
- 9 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation
- ClinicalTrials.gov ID
- NCT01137669
- Acronym / sponsor ID
- 09-0016
- Conditions
- Herpes Zoster
- Keywords
- immunocompromised,parent protocol,shingles,varicella-zoster virus,ZOSTAVAX®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Jun 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 purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed persons and in the United States for individuals less than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive substance) no less than 4 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for up to 18 months.
Detailed description
Infection with varicella-zoster virus (VZV) produces a life-long latent infection in sensory ganglia. Reactivation of viral replication from latency results in a number of clinical syndromes, most commonly herpes zoster, or shingles. Herpes zoster is typically a unilateral vesicular rash in a dermatomal distribution accompanied by radicular pain that may be severe. Immunocompromised persons are at higher risk for herpes zoster than immunocompetent adults. The markedly increased risk of herpes zoster in organ transplant recipients suggests that this population would benefit substantially if a similar strategy could be adopted. The currently licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live), is not licensed for use in immunosuppressed persons and in the United States for those less than 50 years of age. A small Phase I study is important to address immunogenicity in patients with Chronic Kidney Disease (CKD) prior to transplantation as well as safety and persistence of immune responses following transplantation. This study is a multi-center, double blind, randomized, placebo-controlled trial of ZOSTAVAX® immunization in subjects who will undergo renal transplantation from a living donor or are wait-listed for a deceased donor no less than 4 weeks prior to transplantation. The primary objective of this study is to assess the safety of ZOSTAVAX® when administered to subjects with CKD a minimum of 4 weeks prior to live donor renal transplantation. This will be accomplished by comparing the rates of specific local and systemic reactogenicity events and adverse events (AEs) between the vaccine and placebo groups. Subjects likely to be suitable for renal transplant and who have an identified living donor will be consented for screening serology for antibodies to VZV if such serology is not standard of care or serostatus is not known. Subjects with positive VZV serology, an identified living donor, and meeting inclusion and exclusion criteria will provide signed informed consent for study enrollment. Subjects will be randomized to receive either active vaccine (ZOSTAVAX®) [30 subjects] or placebo vaccine [10 subjects]. Blood will be drawn on day 0 (day of vaccine) prior to vaccine administration for assessment of baseline humoral and cellular immunity to VZV. Subjects will receive ZOSTAVAX® or placebo vaccination. At approximately 5 weeks post-vaccination, subjects will have blood drawn for measurement of humoral and cellular immune response. Subjects will undergo living donor renal transplant with immunosuppression according to standard of care at each institution. All transplanted subjects will receive anti-viral prophylaxis for 3 months post-transplant, consisting of either valganciclovir (or ganciclovir) or acyclovir (or valacyclovir or famciclovir) depending on risk of cytomegalovirus (CMV) disease. Subjects will be followed and treated by the renal transplant team at each center according to local standard of care with concomitant monitoring by the vaccine study teams. Subjects will have blood drawn for humoral and cell-mediated immune assays at day 0, and week 5 post vaccination, and 6 months and 12 months post-transplantation if they undergo transplantation. Parent protocol to sub-study 09-0025.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo10 subjects to receive placebo subcutaneously. |
| ZOSTAVAX® | Experimental | Biological: Live attenuated herpes zoster vaccine30 subjects to receive 0.65 mL ZOSTAVAX® subcutaneously. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Subjects must be willing and able to provide informed consent prior to study procedures. -Age 18 years or older at the time of vaccination. -Chronic kidney disease (CKD) activated on the United Network for Organ Sharing (UNOS) deceased donor waitlist or anticipating living donor renal transplant no sooner than 4 weeks following vaccination. -Varicella Zoster Virus (VZV) seropositive by local laboratory or Center for Disease Control (CDC) serologic testing -Negative pregnancy test (women of childbearing age potential) performed at enrollment- or within 48 hours prior. The use of contraception for women of childbearing potential will be per renal transplant team's standard of care
Key exclusion criteria (1 listed)
- -Any pharmacologic immunosuppression at the time of enrollment, within one year prior to enrollment, or between enrollment and transplant (e.g., for underlying autoimmune disease or previous failed allograft). This includes prednisone at >/= 0.3 mg/kg/day or steroid equivalent for > 10 days, any use of anti-metabolites (azathioprine, mycophenolic acid, cytoxan), leflunomide, TNF-alpha inhibitors, calcineurin inhibitors, mTOR inhibitors, IL-6 or IL-6 receptor inhibitors. -Any transplant other than solitary kidney (e.g., no kidney/pancreas, kidney/liver transplants). Second kidney transplants are permitted. -Anticipated use of any post-transplant experimental immunosuppressive agent -Prior ZOSTAVAX® or Varivax® vaccination -Shingles or any other herpes zoster within 12 months of planned vaccination -Receipt of any killed vaccines within 2 weeks prior and 4 weeks following study vaccination or receipt of any live vaccines within 4 weeks prior and 6 weeks following study vaccination -Intercurrent illness at time of planned vaccination -Inability to vaccinate in either arm (e.g. due to A-V fistula or graft) -Known Human immunodeficiency virus (HIV) infection, Hepatitis C virus (HCV) infection, or chronic hepatitis B determined from review of laboratory data obtained from pre-transplant evaluation by renal transplant team. Note positive IgG hepatitis B surface antibody alone (negative HBcAb and negative IgM) is indicative of vaccine induced immunity and is not grounds for exclusion -History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other components of the vaccine -Asthma requiring systemic or inhaled steroid treatment within 12 months prior to enrollment -Allergy to ganciclovir, valgancyclovir, acyclovir, or famciclovir -Panel Reactive Antibody (PRA) >/= 20 percent or donor-specific sensitization (by solid phase assay or flow cytometry) or treatment with intravenous immunoglobulin (IVIG) for desensitization prior to transplant -History of primary or acquired immunodeficiency states. -Routine use of anti-viral prophylaxis for Herpes Simplex Virus (HSV) at the time of vaccination or within 3 months prior -Any other condition that in the opinion of the investigator might interfere with the subject's safety or ability to participate in the study -Abnormal screening laboratory data resulting in a disqualification of transplant candidacy. Abnormalities due to underlying disease (e.g., renal failure, anemia, hyperlipidemia, cardiovascular disease, diabetes) are not exclusionary except as denoted above for HIV, hepatitis B, hepatitis C, autoimmune disease. -The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. -The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) psychiatric diagnosis identified at the pre-transplant evaluation. -The subject has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others identified at the pre-transplant evaluation. -Dual listing at more than one transplant center. -Unwilling to be temporarily inactivated on UNOS wait list for 4 weeks post 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 |
|---|---|---|
| Live attenuated herpes zoster vaccineZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation. The vaccine will be supplied in 3-mL glass vials. Sterile diluent will be used to reconstitute study vaccine. The reconstituted vial will be gently agitated to mix thoroughly. The entire contents of the reconstituted vaccine vial (approximately 0.65 mL) will be withdrawn into a syringe. The vaccine will be administered immediately subcutaneously in the deltoid region. | Biological | ZOSTAVAX® |
| PlaceboPlacebo for Zoster Vaccine Live (ZOSTAVAX®) is sterile normal saline which will be obtained from the Fisher Repository in single-dose containers. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. The placebo will be administered subcutaneously in the deltoid region. | Other | Placebo |
Primary outcome
Biopsy proven graft rejection
Time frame: During 12 months post- vaccination or post- transplantation
Safety: any occurrence of proven [polymerase chain reaction (PCR) confirmed] vaccine strain varicella zoster virus (VZV) infection at any site not contiguous with the injection site.
Time frame: Entire post-immunization period up to 12 months following transplantation.
Safety: incidence of grade 3 or higher vaccine related adverse events (AEs) and vaccine related serious adverse events (SAEs).
Time frame: During the 4 weeks post-immunization.
Safety: incidence of vaccine related serious adverse events (SAEs).
Time frame: During 12 months post- vaccination or post-transplantation
Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) after immunization in the absence of any other attributable cause.
Time frame: Prior to vaccination, to following vaccination while on the wait list (for up to 12 months)
Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) prior to transplantation in the absence of any other attributable cause.
Time frame: Study Day 0, through Study Day 35 post vaccination, or to the time of transplantation in those subjects who are transplanted. The ideal time for transplantation is 6 weeks post vaccination.
2 secondary outcomes
Immune response: changes from baseline glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) varicella zoster virus (VZV) antibody titer.
Time frame: Approximately 5 weeks post immunization, 6 months and 12 months post-vaccination or 6 months and 12 months post-transplantation.If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional.
Immune response: changes from baseline number of VZV specific T cells by flow cytometry measuring intracellular interleukin-2 (IL-2), interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha after stimulation with VZV antigens.
Time frame: Approximately 5 weeks post-immunization, 6 months and 12 months post-immunization or post-transplantation. If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Live attenuated herpes zoster vaccine in people with Herpes Zoster, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biopsy proven graft rejection (time frame: During 12 months post- vaccination or post- transplantation). The study lists 6 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 9 Jan 2017.