Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT01331161
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2011-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053061', 'term': 'Herpes Zoster Vaccine'}], 'ancestors': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nroupha@emory.edu', 'phone': '404-712-1435', 'title': 'Nadine Rouphael, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Older Group', 'description': 'Participants between the ages of 60-79\n\nZOSTAVAX: shingles vaccine, one dose', 'otherNumAtRisk': 44, 'otherNumAffected': 13, 'seriousNumAtRisk': 44, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Younger Group', 'description': 'Participants between the ages of 25-40\n\nZOSTAVAX: shingles vaccine, one dose', 'otherNumAtRisk': 33, 'otherNumAffected': 3, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Local Injection site reactions', 'notes': 'All were attributed as related to study product- severity was between 1 and 2- all resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise at blood draw site', 'notes': 'realted to phlebotomy intervention- all resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold symptoms', 'notes': 'None related to study product- severity varied between 1 to 3 - all resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyponatremia', 'notes': 'resulted in hospitalization- unrelated to study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'notes': 'Breast cancer unrelated to study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants 60-79 Years', 'description': 'participants who received one dose of vaccine'}, {'id': 'OG001', 'title': 'Participants 25-40 Years of Age', 'description': 'participants with one dose of vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with immunoglobulin gene responses that correlated with adaptive immune responses'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 60-79 Years', 'description': 'Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.'}, {'id': 'OG001', 'title': 'Age 25-40 Years', 'description': 'Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both T and B cell responses to vaccine'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Older Group', 'description': 'Participants between the ages of 60-79\n\nZOSTAVAX: shingles vaccine, one dose'}, {'id': 'FG001', 'title': 'Younger Group', 'description': 'Participants between the ages of 25-40\n\nZOSTAVAX: shingles vaccine, one dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Age 60-79 Years', 'description': 'Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.'}, {'id': 'BG001', 'title': 'Age 25-40 Years', 'description': 'Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '77'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '40'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Non hispanic', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2013-04-23', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2011-04-06', 'dispFirstSubmitQcDate': '2013-04-23', 'resultsFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2011-04-06', 'dispFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-19', 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX', 'timeFrame': '2 years', 'description': 'The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX', 'timeFrame': '2 years', 'description': 'The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shingles vaccine', 'immune responses'], 'conditions': ['Shingles']}, 'descriptionModule': {'briefSummary': 'Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.\n\nIn this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.', 'detailedDescription': 'RATIONALE: Zoster vaccine is known to induce diminished antigen-specific T cell responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses to the live attenuated virus, which translates into sub-optimal functional adaptive immune responses. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of Zoster vaccine in the young and elderly.\n\nSTUDY DESIGN: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected on day D-30 (pre- vaccination) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 (post vaccination) to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and give informed consent.\n* Immunocompetent subjects aged 25-40 years, or community dwelling subjects between the ages of 60-79.\n\nExclusion Criteria:\n\n* Young adults aged 25-40 years who are Varicella-Zoster virus seronegative or equivocal results (mean value OD for Varicella-Zoster virus IgG lower than 1.1 by commercial enzyme-linked immunosorbent assay (ELISA) (Hope Clinic: IgG VZV ELISAII-Wampole Laboratories®, NJ, USA- Vaccine Research Trials Center:: Liaison VZV IgG Assay, DiaSorin, Italy)\n* Receipt of immune products:\n\n * Receipt of blood products within 6 months prior to vaccination with Zoster vaccine or expected receipt through 6 months after vaccination with Zoster vaccine\\*\n * Receipt of any vaccine within 4 weeks prior to vaccination with Zoster vaccine or expected receipt within 4 weeks after vaccination with Zoster vaccine\\*\n * Receipt of Zoster vaccine or varicella vaccines at any time prior to study entry.\n* Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir 3 days prior to vaccination or 14 days after\\*.\n* Prior history of shingles.\n* Presence of certain co morbidities or immunosuppressive states such as:\n\n * Chronic medical problems including (but not limited to) insulin-dependent diabetes, severe heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.\n * Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.\n * Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C, tuberculosis, organ transplant, cancer, current and or expected receipt of chemotherapy, radiation therapy, steroids \\[i.e., \\> 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days\\*); (nasal and topical steroids are allowed)\\],antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.\n * Pregnant or breast-feeding women, or women expecting to conceive 30 days before and 90 days after vaccination\\*\\*.\n* Conditions that could affect the safety of the volunteers such as:\n\n * Severe reactions to prior vaccinations.\n * History of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine.\n * History of bleeding disorders\n* Any acute illness, including any fever (\\> 100.4 F \\[\\> 38.0C\\], regardless of the route) within 3 days prior to study entry \\*.\n* Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.\n\nNote:\n\n\\*An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be considered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.\n\nSubjects receiving \\> 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.\n\n\\*\\*Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 90 days after zoster vaccination.'}, 'identificationModule': {'nctId': 'NCT01331161', 'briefTitle': 'Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly', 'orgStudyIdInfo': {'id': 'IRB00050285'}, 'secondaryIdInfos': [{'id': 'U19AI090023', 'link': 'https://reporter.nih.gov/quickSearch/U19AI090023', 'type': 'NIH'}, {'id': 'HIPCVAX005', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Older group', 'description': 'Participants between the ages of 60-79', 'interventionNames': ['Biological: ZOSTAVAX']}, {'type': 'EXPERIMENTAL', 'label': 'Younger group', 'description': 'Participants between the ages of 25-40', 'interventionNames': ['Biological: ZOSTAVAX']}], 'interventions': [{'name': 'ZOSTAVAX', 'type': 'BIOLOGICAL', 'otherNames': ['shingles vaccine'], 'description': 'shingles vaccine, one dose', 'armGroupLabels': ['Older group', 'Younger group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Nadine Rouphael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nadine Rouphael', 'investigatorAffiliation': 'Emory University'}}}}