Cytomegalovirus InfectionsPhase 1NCT01986010

Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

A Phase 1 study testing V160 Low Dose IM, V160 Medium Dose IM and V160 High Dose IM in people with Cytomegalovirus Infections, 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cytomegalovirus Infections
What is being tested?: V160 Low Dose IM, V160 Medium Dose IM and V160 High Dose IM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: No sites listed yet
Study dates: 25 Nov 2013to 14 Mar 2017
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy based on medical history and physical examination
Serologically confirmed to be HCMV seronegative or HCMV seropositive
Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine
Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2
If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity

Who cannot join

Has previously received any cytomegalovirus vaccine
Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
Has history of any severe allergic reaction that required medical intervention
Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine
Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug
Has impairment of immunologic function including, but not limited to autoimmune disease, splenectomy, or human immunodeficiency virus acquired immunodeficiency syndrome (HIV/AIDS)

Show all 15Show fewer

Received systemic corticosteroids for ≥14 consecutive days and has not completed treatment within 30 days of study start
Received immunosuppressive therapy including, but not limited to rapamycin and equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy, or other therapy known to interfere with the immune response within 1 year of study start
Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or significantly impaired venous access
Has a condition that requires active medical intervention or monitoring such as diabetes mellitus, autoimmune disease, or a clinically significant chronic medical condition that is considered progressive
Has history within the past 5 years or current drug or alcohol abuse
Has major psychiatric illness
Is legally or mentally incapacitated
Has participated in another clinical study in the past 4 weeks, or plans during the present study to participate in a treatment-based study or a study in which an invasive procedure is performed
Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from 4 weeks prior to 1 month following each V160 vaccination

About this study

Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults

This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.

Conditions: Cytomegalovirus Infections
Being tested: V160 Low Dose IM, V160 Medium Dose IM, V160 High Dose IM, V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM, V160 High Dose plus MAPA 225 µg /dose IM
Medical subject headings: Cytomegalovirus Infections

What participants receive

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

V160 Low Dose IMBiological
V160 administered as a 0.75 mL intramuscular injection
V160 Medium Dose IMBiological
V160 administered as a 0.75 mL intramuscular injection
V160 High Dose IMBiological
V160 administered as a 0.75 mL intramuscular injection
V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IMBiological
V160 plus MAPA administered as a 0.75 mL intramuscular injection
V160 High Dose plus MAPA 225 µg /dose IMBiological
V160 plus MAPA administered as a 0.75 mL intramuscular injection
V160 Maximum Dose IMBiological
V160 administered as a 0.75 mL intramuscular injection
Placebo IMOther
Placebo administered as a 0.75 mL intramuscular injection
V160 Medium Dose IDBiological
V160 administered as a 0.1 mL intradermal injection
Placebo IDOther
Placebo administered as a 0.1 mL intradermal injection

Study groups in NCT01986010
Study group	Role	What they receive
HCMV seropositive (+) V160 Low Dose Intramuscular (IM)	Experimental	Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Low Dose IM
HCMV seronegative (-) V160 Low Dose IM	Experimental	Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Low Dose IM
HCMV+ V160 Medium Dose IM	Experimental	Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Medium Dose IM
HCMV- V160 Medium Dose IM	Experimental	Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Medium Dose IM
HCMV+ V160 High Dose IM	Experimental	Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 High Dose IM
HCMV- V160 Medium Dose plus MAPA 225 µg IM	Experimental	Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
HCMV- V160 High Dose IM	Experimental	Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 High Dose IM
HCMV+ V160 High Dose plus MAPA 225 µg IM	Experimental	Participants seropositive for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 High Dose plus MAPA 225 µg /dose IM
HCMV+ V160 Maximum Dose IM	Experimental	Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Maximum Dose IM
HCMV- V160 High Dose plus MAPA 225 µg IM	Experimental	Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 High Dose plus MAPA 225 µg /dose IM
HCMV- V160 Maximum Dose IM	Experimental	Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Maximum Dose IM
HCMV+ Placebo IM	Placebo comparator	Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6 Receives: Other: Placebo IM
HCMV- Placebo IM	Placebo comparator	Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6 Receives: Other: Placebo IM
HCMV+ V160 Medium Dose Intradermal (ID)	Experimental	Participants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Medium Dose ID
HCMV- V160 Medium Dose ID	Experimental	Participants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6 Receives: Biological: V160 Medium Dose ID
HCMV+ Placebo ID	Placebo comparator	Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6 Receives: Other: Placebo ID
HCMV- Placebo ID	Placebo comparator	Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6 Receives: Other: Placebo ID

What is being measured

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

Percentage of Participants With an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With an Injection-site AE
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Measured: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Systemic AE
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Measured: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Serious Adverse Event (SAE)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
Measured: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Serious Vaccine-Related Adverse Event
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
Measured: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to Month 6
Percentage of Participants With Events of Clinical Interest (ECI)
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase <2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
Measured: Up to 18 months
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.
Measured: Month 7 (1 month after vaccination 3 at Month 6)

Secondary outcomes (3)

Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock.
Measured: Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB.
Measured: Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA.
Measured: Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])

Timeline

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

25 Nov 201314 Mar 2017

First posted18 Nov 2013 (estimated)
Study start25 Nov 2013
Primary completion19 Apr 2016
Study completion14 Mar 2017

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 (2)Papers the sponsor has linked to this study.
Other trials for Cytomegalovirus InfectionsStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986010
Sponsor's protocol ID: V160-001
Status last verified: Sep 2021
First submitted: 11 Nov 2013
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Cox KS, Zhang L, Freed DC, Tang A, Zhang S, Zhou Y, Wang IM, Rupp RE, Adler SP, Musey LK, Wang D, Vora KA, Fu TM. Functional Evaluation and Genetic Evolution of Human T-Cell Responses After Vaccination With a Conditionally Replication-Defective Cytomegalovirus Vaccine. J Infect Dis. 2021 Jun 4;223(11):2001-2012. doi: 10.1093/infdis/jiaa631.
PubMed 33031517
Adler SP, Lewis N, Conlon A, Christiansen MP, Al-Ibrahim M, Rupp R, Fu TM, Bautista O, Tang H, Wang D, Fisher A, Culp T, Das R, Beck K, Tamms G, Musey L; V160-001 Study Group. Phase 1 Clinical Trial of a Conditionally Replication-Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. J Infect Dis. 2019 Jul 2;220(3):411-419. doi: 10.1093/infdis/jiz141.
PubMed 31535143

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

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

All Cytomegalovirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults
ClinicalTrials.gov ID: NCT01986010
Acronym / sponsor ID: V160-001
Conditions: Cytomegalovirus Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Nov 2013 (actual)
Primary completion: 19 Apr 2016 (actual)
Study completion: 14 Mar 2017 (actual)
First posted: 18 Nov 2013 (estimated)
Results: Posted 1 Nov 2021

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 17

Arm	Type	Receives
HCMV seropositive (+) V160 Low Dose Intramuscular (IM)	Experimental	Biological: V160 Low Dose IMParticipants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV seronegative (-) V160 Low Dose IM	Experimental	Biological: V160 Low Dose IMParticipants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV+ V160 Medium Dose IM	Experimental	Biological: V160 Medium Dose IMParticipants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV- V160 Medium Dose IM	Experimental	Biological: V160 Medium Dose IMParticipants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV+ V160 High Dose IM	Experimental	Biological: V160 High Dose IMParticipants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV- V160 Medium Dose plus MAPA 225 µg IM	Experimental	Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IMParticipants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
HCMV- V160 High Dose IM	Experimental	Biological: V160 High Dose IMParticipants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV+ V160 High Dose plus MAPA 225 µg IM	Experimental	Biological: V160 High Dose plus MAPA 225 µg /dose IMParticipants seropositive for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
HCMV+ V160 Maximum Dose IM	Experimental	Biological: V160 Maximum Dose IMParticipants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV- V160 High Dose plus MAPA 225 µg IM	Experimental	Biological: V160 High Dose plus MAPA 225 µg /dose IMParticipants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
HCMV- V160 Maximum Dose IM	Experimental	Biological: V160 Maximum Dose IMParticipants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
HCMV+ Placebo IM	Placebo comparator	Other: Placebo IMParticipants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
HCMV- Placebo IM	Placebo comparator	Other: Placebo IMParticipants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
HCMV+ V160 Medium Dose Intradermal (ID)	Experimental	Biological: V160 Medium Dose IDParticipants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
HCMV- V160 Medium Dose ID	Experimental	Biological: V160 Medium Dose IDParticipants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
HCMV+ Placebo ID	Placebo comparator	Other: Placebo IDParticipants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
HCMV- Placebo ID	Placebo comparator	Other: Placebo IDParticipants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy based on medical history and physical examination
Serologically confirmed to be HCMV seronegative or HCMV seropositive
Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine
Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2
If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity

Key exclusion criteria (15 listed)

Has previously received any cytomegalovirus vaccine
Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
Has history of any severe allergic reaction that required medical intervention
Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine
Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug

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
V160 Low Dose IMV160 administered as a 0.75 mL intramuscular injection	Biological	HCMV seronegative (-) V160 Low Dose IM, HCMV seropositive (+) V160 Low Dose Intramuscular (IM)
V160 Medium Dose IMV160 administered as a 0.75 mL intramuscular injection	Biological	HCMV+ V160 Medium Dose IM, HCMV- V160 Medium Dose IM
V160 High Dose IMV160 administered as a 0.75 mL intramuscular injection	Biological	HCMV+ V160 High Dose IM, HCMV- V160 High Dose IM
V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IMV160 plus MAPA administered as a 0.75 mL intramuscular injection	Biological	HCMV- V160 Medium Dose plus MAPA 225 µg IM
V160 High Dose plus MAPA 225 µg /dose IMV160 plus MAPA administered as a 0.75 mL intramuscular injection	Biological	HCMV+ V160 High Dose plus MAPA 225 µg IM, HCMV- V160 High Dose plus MAPA 225 µg IM
V160 Maximum Dose IMV160 administered as a 0.75 mL intramuscular injection	Biological	HCMV+ V160 Maximum Dose IM, HCMV- V160 Maximum Dose IM
Placebo IMPlacebo administered as a 0.75 mL intramuscular injection	Other	HCMV+ Placebo IM, HCMV- Placebo IM
V160 Medium Dose IDV160 administered as a 0.1 mL intradermal injection	Biological	HCMV+ V160 Medium Dose Intradermal (ID), HCMV- V160 Medium Dose ID
Placebo IDPlacebo administered as a 0.1 mL intradermal injection	Other	HCMV+ Placebo ID, HCMV- Placebo ID

Primary outcome

Percentage of Participants With an Adverse Event (AE)
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Percentage of Participants With an Injection-site AE
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Percentage of Participants With a Systemic AE
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Percentage of Participants With a Serious Adverse Event (SAE)
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
Percentage of Participants With a Serious Vaccine-Related Adverse Event
Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to Month 6
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Percentage of Participants With Events of Clinical Interest (ECI)
Time frame: Up to 18 months
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase <2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.

3 secondary outcomes

Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
Time frame: Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Time frame: Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])

Results and safety

Results posted to the registry on 1 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HCMV Seropositive (+) V160 10u Intramuscular (IM)	13	7
HCMV + V160 30u IM	14	6
HCMV+ V160 100u IM	14	7
HCMV+ V160 100u MAPA IM	10	8
HCMV+ V160 250u IM	11	6
HCMV+ Placebo IM	19	11
HCMV+ V160 30u ID	10	10
HCMV+ Placebo ID	4	4
HCMV Seronegative (-) V160 10u IM	12	6
HCMV- V160 30u IM	10	7
HCMV- V160 30u MAPA IM	10	3
HCMV- V160 100u IM	11	1
HCMV- V160 100u MAPA IM	10	0
HCMV- V160 250u IM	11	0
HCMV- V160 Placebo IM	16	6
HCMV- V160 30u ID	11	0
HCMV- Placebo ID	4	0

Primary outcome: Percentage of Participants With an Adverse Event (AE)

Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26). Number. Unit: Percentage of participants

Measure	HCMV Seropositive (+) V160 10u Intramuscular (IM) n = 12	HCMV + V160 30u IM n = 14	HCMV+ V160 100u IM n = 13	HCMV+ V160 100u MAPA IM n = 10	HCMV+ V160 250u IM n = 11	HCMV+ Placebo IM n = 19	HCMV+ V160 30u ID n = 10	HCMV+ Placebo ID n = 4	HCMV Seronegative (-) V160 10u IM n = 12	HCMV- V160 30u IM n = 10	HCMV- V160 30u MAPA IM n = 10	HCMV- V160 100u IM n = 11	HCMV- V160 100u MAPA IM n = 10	HCMV- V160 250u IM n = 11	HCMV- V160 Placebo IM n = 16	HCMV- V160 30u ID n = 11	HCMV- Placebo ID n = 4
Value	75.0	92.9	84.6	100.0	100.0	57.9	100.0	50.0	75.0	90.0	90.0	100.0	90.0	90.9	56.3	100.0	100.0

Population analysed: All randomized participants who received at least 1 vaccination and had follow-up safety data available

Primary outcome: Percentage of Participants With an Injection-site AE

Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26). Number. Unit: Percentage of participants

Measure	HCMV Seropositive (+) V160 10u Intramuscular (IM) n = 12	HCMV + V160 30u IM n = 14	HCMV+ V160 100u IM n = 13	HCMV+ V160 100u MAPA IM n = 10	HCMV+ V160 250u IM n = 11	HCMV+ Placebo IM n = 19	HCMV+ V160 30u ID n = 10	HCMV+ Placebo ID n = 4	HCMV Seronegative (-) V160 10u IM n = 12	HCMV- V160 30u IM n = 10	HCMV- V160 30u MAPA IM n = 10	HCMV- V160 100u IM n = 11	HCMV- V160 100u MAPA IM n = 10	HCMV- V160 250u IM n = 11	HCMV- V160 Placebo IM n = 16	HCMV- V160 30u ID n = 11	HCMV- Placebo ID n = 4
Value	58.3	85.7	69.2	80.0	100.0	26.3	90.0	0.0	66.7	80.0	80.0	90.9	90.0	81.8	31.3	100.0	50.0

Population analysed: All randomized participants who received at least 1 vaccination and had follow-up safety data available

Primary outcome: Percentage of Participants With a Systemic AE

Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26). Number. Unit: Percentage of participants

Measure	HCMV Seropositive (+) V160 10u Intramuscular (IM) n = 12	HCMV + V160 30u IM n = 14	HCMV+ V160 100u IM n = 13	HCMV+ V160 100u MAPA IM n = 10	HCMV+ V160 250u IM n = 11	HCMV+ Placebo IM n = 19	HCMV+ V160 30u ID n = 10	HCMV+ Placebo ID n = 4	HCMV Seronegative (-) V160 10u IM n = 12	HCMV- V160 30u IM n = 10	HCMV- V160 30u MAPA IM n = 10	HCMV- V160 100u IM n = 11	HCMV- V160 100u MAPA IM n = 10	HCMV- V160 250u IM n = 11	HCMV- V160 Placebo IM n = 16	HCMV- V160 30u ID n = 11	HCMV- Placebo ID n = 4
Value	66.7	64.3	69.2	90.0	90.9	57.9	80.0	50.0	66.7	90.0	70.0	100.0	70.0	90.9	56.3	100.0	100.0

Population analysed: All randomized participants who received at least 1 vaccination and had follow-up safety data available

Primary outcome: Percentage of Participants With a Serious Adverse Event (SAE)

Time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26). Number. Unit: Percentage of participants

Measure	HCMV Seropositive (+) V160 10u Intramuscular (IM) n = 12	HCMV + V160 30u IM n = 14	HCMV+ V160 100u IM n = 13	HCMV+ V160 100u MAPA IM n = 10	HCMV+ V160 250u IM n = 11	HCMV+ Placebo IM n = 19	HCMV+ V160 30u ID n = 10	HCMV+ Placebo ID n = 4	HCMV Seronegative (-) V160 10u IM n = 12	HCMV- V160 30u IM n = 10	HCMV- V160 30u MAPA IM n = 10	HCMV- V160 100u IM n = 11	HCMV- V160 100u MAPA IM n = 10	HCMV- V160 250u IM n = 11	HCMV- V160 Placebo IM n = 16	HCMV- V160 30u ID n = 11	HCMV- Placebo ID n = 4
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least 1 vaccination and had follow-up safety data available

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HCMV + V160 10u IM	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13
HCMV + V160 30u IM	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
HCMV + V160 100u IM	0 of 14 (0%)	12 of 14 (85.7%)	0 of 14
HCMV+ V160 100u MAPA IM	0 of 10 (0%)	10 of 10 (100%)	0 of 10
HCMV + V160 250u IM	0 of 11 (0%)	11 of 11 (100%)	0 of 11
HCMV+ Placebo IM	0 of 19 (0%)	12 of 19 (63.2%)	0 of 19
HCMV + V160 30u ID	0 of 10 (0%)	10 of 10 (100%)	0 of 10
HCMV+ Placebo ID	0 of 4 (0%)	2 of 4 (50%)	0 of 4
HCMV- V160 10u IM	0 of 12 (0%)	9 of 12 (75%)	0 of 12
HCMV- V160 30u IM	0 of 10 (0%)	9 of 10 (90%)	0 of 10
HCMV- V160 30u MAPA IM	0 of 10 (0%)	9 of 10 (90%)	0 of 10
HCMV- V160 100u IM	0 of 11 (0%)	11 of 11 (100%)	0 of 11
HCMV- V160 100u MAPA IM	0 of 10 (0%)	9 of 10 (90%)	0 of 10
HCMV- V160 250u IM	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11
HCMV- V160 Placebo IM	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16
HCMV- V160 30u ID	0 of 11 (0%)	11 of 11 (100%)	0 of 11
HCMV- V160 Placebo ID	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33031517Cox KS, Zhang L, Freed DC, Tang A, Zhang S, Zhou Y, Wang IM, Rupp RE, Adler SP, Musey LK, Wang D, Vora KA, Fu TM. Functional Evaluation and Genetic Evolution of Human T-Cell Responses After Vaccination With a Conditionally Replication-Defective Cytomegalovirus Vaccine. J Infect Dis. 2021 Jun 4;223(11):2001-2012. doi: 10.1093/infdis/jiaa631.
Derived from this study: PubMed 31535143Adler SP, Lewis N, Conlon A, Christiansen MP, Al-Ibrahim M, Rupp R, Fu TM, Bautista O, Tang H, Wang D, Fisher A, Culp T, Das R, Beck K, Tamms G, Musey L; V160-001 Study Group. Phase 1 Clinical Trial of a Conditionally Replication-Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. J Infect Dis. 2019 Jul 2;220(3):411-419. doi: 10.1093/infdis/jiz141.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Cytomegalovirus Infections

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

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 V160 Low Dose IM, V160 Medium Dose IM and V160 High Dose IM in people with Cytomegalovirus Infections, 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 5 inclusion and 15 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 1 Nov 2021. 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 1 Nov 2021). 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?

Percentage of Participants With an Adverse Event (AE) (time frame: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)). The study lists 8 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 NCT01986010, which also lists 2 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 1 Nov 2021.