A Phase 1 interventional study of V212 in Herpes Zoster, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Prevention
An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at \~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 80 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: V212
V212 viral antigen for HZ
Also known as: Inactivated Varicella-Zoster (VZV) vaccine
Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)
The VZV ELISPOT 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 on Day 1.
Time frame: Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)
Percentage of Participants With an Adverse Event
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.
Time frame: Up to ~28 days after Vaccination 4 (~Day 118)
Percentage of Participants With an Injection-site Adverse Event
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.
Time frame: Up to 5 days after any vaccination
Percentage of Participants With a Systemic Adverse Event
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.
Time frame: Up to ~28 days after Vaccination 4 (~Day 118)
Percentage of Participants With a Serious Adverse Event
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.
Time frame: Up to ~28 days after Vaccination 4 (~Day 118)
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.
Time frame: Up to ~28 days after Vaccination 4 (~Day 118)
Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.
Time frame: Up to Vaccination 4 (~Day 90)
A total of 88 participants were screened and 80 were enrolled.
| Milestone | V212 |
|---|---|
| Started | 80 |
| Vaccination 1 (day 1) | 80 |
| Vaccination 2 (~day 30) | 78 |
| Vaccination 3 (~day 60) | 78 |
| Vaccination 4 (~day 90) | 78 |
| Completed | 78 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
The VZV ELISPOT 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 on Day 1.
| Ratio | V212 |
|---|---|
| Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT) | 4.34 (3.01 to 6.24) |
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With an Adverse Event | 85.0 |
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With an Injection-site Adverse Event | 43.8 |
An adverse experience (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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With a Systemic Adverse Event | 73.8 |
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With a Serious Adverse Event | 15.0 |
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With a Vaccine-related Serious Adverse Event | 1.3 |
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 product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.
| Percentage of participants | V212 |
|---|---|
| Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 1.3 |
Collected over Up to Day 140. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V212 | 1/80 (1.3%) | 12/80 (15%) | 67/80 (83.8%) |
| Event | V212 |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 4/80 |
| NeutropeniaBlood and lymphatic system disorders | 2/80 |
| PneumoniaInfections and infestations | 2/80 |
| DiarrhoeaGastrointestinal disorders | 1/80 |
| NauseaGastrointestinal disorders | 1/80 |
| PyrexiaGeneral disorders | 1/80 |
| CandidiasisInfections and infestations | 1/80 |
| SalmonellosisInfections and infestations | 1/80 |
| Subdural haematomaInjury, poisoning and procedural complications | 1/80 |
| Hodgkin's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/80 |
| Event | V212 |
|---|---|
| Injection site painGeneral disorders | 26/80 |
| Injection site erythemaGeneral disorders | 25/80 |
| Injection site swellingGeneral disorders | 21/80 |
| PyrexiaGeneral disorders | 20/80 |
| DiarrhoeaGastrointestinal disorders | 10/80 |
| HeadacheNervous system disorders | 7/80 |
| NeutropeniaBlood and lymphatic system disorders | 6/80 |
| Arthropod biteInjury, poisoning and procedural complications | 6/80 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/80 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 6/80 |
| Age, Continuous(Years) | V212 |
|---|---|
| Mean | 61.0 ± 11.3 |
| Sex: Female, Male(Participants) | V212 |
|---|---|
| Female | 43 |
| Male | 37 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Merck Sharp & Dohme LLC