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| ID | Type | Description | Link |
|---|---|---|---|
| V212-009 | Other Identifier | Merck Protocol Number | |
| 2011-002313-11 | EudraCT Number |
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This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V212 | Experimental | Participants receive V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
|
| Placebo | Placebo Comparator | Participants receive placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V212 | Biological | V212 viral antigen for HZ |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and ~28 days after Vaccination 4 (~Day 118) |
| GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | Serum samples were tested for activity using a VZV ELISPOT assay. The assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC predose on Day 1. | Baseline and ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs were erythema, pain, and swelling. The percentage of participants with one or more VRC-prompted injection-site AE was assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29126292 | Result | Eberhardson M, Hall S, Papp KA, Sterling TM, Stek JE, Pang L, Zhao Y, Parrino J, Popmihajlov Z. Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Clin Infect Dis. 2017 Oct 1;65(7):1174-1182. doi: 10.1093/cid/cix484. |
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A total of 362 participants were screened and 354 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| FG001 | Placebo | Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1. | Participants with Day 1 and/or postdose data available. This outcome measure applied only to participants who received V212; placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days after Vaccination 4 (~Day 118) |
|
Up to Day 140
All participants who received at least one dose of vaccine and had safety follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Biological | Placebo comparator to V212 vaccine |
|
| Up to Day 5 after any vaccination |
| Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and HZ-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card | Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Physician Decision |
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| Pregnancy |
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| Protocol Violation |
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| Screen failure |
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| Participant moved |
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| Withdrawal by Subject |
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Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Autoimmune Therapy Regimen: Biologic or Non-biologic | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | Serum samples were tested for activity using a VZV ELISPOT assay. The assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC predose on Day 1. | Participants with Day 1 and/or postdose data available. This outcome measure applied only to participants who received V212; placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days after Vaccination 4 (~Day 118) |
|
|
|
|
| Primary | Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed. | All participants who received at least one dose of vaccine and had safety follow-up | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
|
|
|
| Secondary | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs were erythema, pain, and swelling. The percentage of participants with one or more VRC-prompted injection-site AE was assessed. | All participants who received at least one dose of vaccine and had safety follow-up | Posted | Number | Percentage of participants | Up to Day 5 after any vaccination |
|
|
|
| Secondary | Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and HZ-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed. | All participants who received at least one dose of vaccine and had safety follow-up | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
|
|
|
| Secondary | Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card | Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed. | All participants who received at least one dose of vaccine and had safety follow-up | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
|
|
|
| 1 |
| 289 |
| 9 |
| 289 |
| 171 |
| 289 |
| EG001 | Placebo | Participants received placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 0 | 62 | 1 | 62 | 11 | 62 |
| Keratitis | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| D007239 | Infections |
| Injection-site swelling |
|