Herpes ZosterPhase 1NCT00535236

A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

A Phase 1 study testing V212 in people with Herpes Zoster and Herpes Zoster-related Complications, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Herpes Zoster, Herpes Zoster-related Complications
What is being tested?: V212
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 341 participants
Where: No sites listed yet
Study dates: 2 Nov 2007to 26 Jan 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3
Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Who cannot join

History of allergy to any vaccine component
Prior history of HZ
Prior history of receipt of any varicella or zoster vaccine

About this study

Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults

This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.

Conditions: Herpes Zoster, Herpes Zoster-related Complications
Being tested: V212, Placebo
Keywords: Prevention of herpes zoster and HZ-related complications
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V212Biological
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
PlaceboBiological
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Study groups in NCT00535236
Study group	Role	What they receive
Autologous HCT-V212	Experimental	Participants receive V212 as a 0.65 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. Receives: Biological: V212
Autologous HCT-Placebo	Placebo comparator	Participants receive placebo as a 0.65 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. Receives: Biological: Placebo
Allogeneic HCT-V212	Experimental	Participants receive V212 as a 0.65 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. Receives: Biological: V212
Allogeneic HCT-Placebo	Placebo comparator	Participants receive placebo as a 0.65 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. Receives: Biological: Placebo
STM-V212	Experimental	Participants receive V212 as a 0.65 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. Receives: Biological: V212
STM-Placebo	Placebo comparator	Participants receive placebo as a 0.65 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. Receives: Biological: Placebo
HM-V212	Experimental	Participants receive V212 as a 0.65 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. Receives: Biological: V212
HM-Placebo	Placebo comparator	Participants receive placebo as a 0.65 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. Receives: Biological: Placebo
HIV-V212	Experimental	Participants receive V212 as a 0.65 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. Receives: Biological: V212
HIV-Placebo	Placebo comparator	Participants receive placebo as a 0.65 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. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Measured: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Measured: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
An SAE was 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 that experienced at least 1 SAE was summarized.
Measured: up to 28 days post vaccination 4 (up to ~Day 118)

Secondary outcomes (3)

Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.
Measured: Up to Day 5 post any vaccination
Percentage of Participants With a Systemic Adverse Event Prompted on the VRC
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.
Measured: Up to 28 days post vaccination 4 (up to ~118 days)
Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.
Measured: Up to 28 days post any vaccination (up to ~118 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 200726 Jan 2010

First posted26 Sep 2007 (estimated)
Study start2 Nov 2007
Primary completion25 Jan 2010
Study completion26 Jan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00535236
Sponsor's protocol ID: V212-002
Other IDs: 2007_608, V212-002
Status last verified: May 2019
First submitted: 25 Sep 2007
Last updated: 20 May 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
PubMed 40396505
Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
PubMed 40237463
Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.
PubMed 23908479

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults
ClinicalTrials.gov ID: NCT00535236
Acronym / sponsor ID: V212-002
Conditions: Herpes Zoster, Herpes Zoster-related Complications
Keywords: Prevention of herpes zoster and HZ-related complications
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 2 Nov 2007 (actual)
Primary completion: 25 Jan 2010 (actual)
Study completion: 26 Jan 2010 (actual)
First posted: 26 Sep 2007 (estimated)
Results: Posted 16 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Autologous HCT-V212	Experimental	Biological: V212Participants receive V212 as a 0.65 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.
Autologous HCT-Placebo	Placebo comparator	Biological: PlaceboParticipants receive placebo as a 0.65 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.
Allogeneic HCT-V212	Experimental	Biological: V212Participants receive V212 as a 0.65 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.
Allogeneic HCT-Placebo	Placebo comparator	Biological: PlaceboParticipants receive placebo as a 0.65 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.
STM-V212	Experimental	Biological: V212Participants receive V212 as a 0.65 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.
STM-Placebo	Placebo comparator	Biological: PlaceboParticipants receive placebo as a 0.65 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.
HM-V212	Experimental	Biological: V212Participants receive V212 as a 0.65 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.
HM-Placebo	Placebo comparator	Biological: PlaceboParticipants receive placebo as a 0.65 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.
HIV-V212	Experimental	Biological: V212Participants receive V212 as a 0.65 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.
HIV-Placebo	Placebo comparator	Biological: PlaceboParticipants receive placebo as a 0.65 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3
Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Key exclusion criteria (3 listed)

History of allergy to any vaccine component
Prior history of HZ
Prior history of receipt of any varicella or zoster vaccine

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
V2120.65 ml V212 in 4 dose regimen. Treatment period of 125 days	Biological	Allogeneic HCT-V212, Autologous HCT-V212, HIV-V212, HM-V212, STM-V212
Placebo0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days	Biological	Allogeneic HCT-Placebo, Autologous HCT-Placebo, HIV-Placebo, HM-Placebo, STM-Placebo

Primary outcome

Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Time frame: up to 28 days post vaccination 4 (up to ~Day 118)
An SAE was 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 that experienced at least 1 SAE was summarized.

3 secondary outcomes

Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)
Time frame: Up to Day 5 post any vaccination
Percentage of Participants With a Systemic Adverse Event Prompted on the VRC
Time frame: Up to 28 days post vaccination 4 (up to ~118 days)
Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC
Time frame: Up to 28 days post any vaccination (up to ~118 days)

Results and safety

Results posted to the registry on 16 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autologous HCT-V212	40	33
Autologous HCT-Placebo	10	8
Allogeneic HCT-V212	41	29
Allogeneic HCT-Placebo	10	6
STM-V212	59	47
STM-Placebo	20	19
HM-V212	62	51
HM-Placebo	19	18
HIV-V212	60	47
HIV-Placebo	20	16

Primary outcome: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)

Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118). Geometric mean (90% Confidence Interval). Unit: Ratio

Measure	STM-V212 n = 55	HM-V212 n = 59	HIV-V212 n = 60
Value	2.35 (1.84 to 3.01)	1.28 (1.12 to 1.45)	1.37 (1.11 to 1.70)

STM-V212: p <0.001, Single longitudinal regression model
HM-V212: p = 0.003, Single longitudinal regression model
HIV-V212: p = 0.017, Single longitudinal regression model

Population analysed: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination gpELISA data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.

Primary outcome: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay

Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118). Geometric mean (90% Confidence Interval). Unit: Ratio

Measure	STM-V212 n = 56	HM-V212 n = 60	HIV-V212 n = 60
Value	3.00 (1.97 to 4.57)	2.23 (1.42 to 3.48)	1.76 (1.17 to 2.67)

STM-V212: p <0.001, Single longitudinal regression model
HM-V212: p = 0.004, Single longitudinal regression model
HIV-V212: p = 0.026, Single longitudinal regression model

Population analysed: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination IFN-g data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.

Primary outcome: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

Time frame: up to 28 days post vaccination 4 (up to ~Day 118). Number. Unit: Percentage of Participants

Measure	Autologous HCT-V212 n = 40	Autologous HCT-Placebo n = 10	Allogeneic HCT-V212 n = 40	Allogeneic HCT-Placebo n = 10	STM-V212 n = 57	STM-Placebo n = 19	HM-V212 n = 61	HM-Placebo n = 19	HIV-V212 n = 60	HIV-Placebo n = 20
Value	32.5	20.0	80.0	70.0	12.3	10.5	19.7	5.3	13.3	10.0

Autologous HCT-V212 vs Autologous HCT-Placebo: Difference in Percentages: 12.5 (95% CI -21.7 to 35.3)
Allogeneic HCT-V212 vs Allogeneic HCT-Placebo: Difference in Percentages: 10.0 (95% CI -15.1 to 42.9)
STM-V212 vs STM-Placebo: Difference in Percentages: 1.8 (95% CI -20.4 to 15.7)

Population analysed: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 days post vaccination 4 (~118 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous HCT-V212	13 of 40 (32.5%)	40 of 40 (100%)	1 of 40
Autologous HCT-Placebo	2 of 10 (20%)	10 of 10 (100%)	0 of 10
Allogeneic-V212	32 of 40 (80%)	40 of 40 (100%)	11 of 40
Allogeneic-Placebo	7 of 10 (70%)	9 of 10 (90%)	2 of 10
STM-V212	7 of 57 (12.3%)	38 of 57 (66.7%)	1 of 57
STM-Placebo	2 of 19 (10.5%)	13 of 19 (68.4%)	0 of 19
HM-V212	12 of 61 (19.7%)	51 of 61 (83.6%)	4 of 61
HM-Placebo	1 of 19 (5.3%)	10 of 19 (52.6%)	0 of 19
HIV-V212	8 of 60 (13.3%)	33 of 60 (55%)	1 of 60
HIV-Placebo	2 of 20 (10%)	12 of 20 (60%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40396505Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
Derived from this study: PubMed 40237463Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
Derived from this study: PubMed 23908479Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V212 in people with Herpes Zoster and Herpes Zoster-related Complications, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 3 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 20 May 2019. 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. 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?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) (time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00535236, which also lists 3 linked publications.

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 20 May 2019.