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

NCT ID: NCT01986010

Last Updated: 2021-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-25

Study Completion Date

2017-03-14

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HCMV seropositive (+) V160 Low Dose Intramuscular (IM)

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Low Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV seronegative (-) V160 Low Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Low Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV+ V160 Medium Dose IM

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Medium Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV- V160 Medium Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Medium Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV+ V160 High Dose IM

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 High Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV- V160 Medium Dose plus MAPA 225 µg IM

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

Group Type EXPERIMENTAL

V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM

Intervention Type BIOLOGICAL

V160 plus MAPA administered as a 0.75 mL intramuscular injection

HCMV- V160 High Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 High Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV+ V160 High Dose plus MAPA 225 µg IM

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

Group Type EXPERIMENTAL

V160 High Dose plus MAPA 225 µg /dose IM

Intervention Type BIOLOGICAL

V160 plus MAPA administered as a 0.75 mL intramuscular injection

HCMV+ V160 Maximum Dose IM

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Maximum Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV- V160 High Dose plus MAPA 225 µg IM

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

Group Type EXPERIMENTAL

V160 High Dose plus MAPA 225 µg /dose IM

Intervention Type BIOLOGICAL

V160 plus MAPA administered as a 0.75 mL intramuscular injection

HCMV- V160 Maximum Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Maximum Dose IM

Intervention Type BIOLOGICAL

V160 administered as a 0.75 mL intramuscular injection

HCMV+ Placebo IM

Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6

Group Type PLACEBO_COMPARATOR

Placebo IM

Intervention Type OTHER

Placebo administered as a 0.75 mL intramuscular injection

HCMV- Placebo IM

Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6

Group Type PLACEBO_COMPARATOR

Placebo IM

Intervention Type OTHER

Placebo administered as a 0.75 mL intramuscular injection

HCMV+ V160 Medium Dose Intradermal (ID)

Participants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Medium Dose ID

Intervention Type BIOLOGICAL

V160 administered as a 0.1 mL intradermal injection

HCMV- V160 Medium Dose ID

Participants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6

Group Type EXPERIMENTAL

V160 Medium Dose ID

Intervention Type BIOLOGICAL

V160 administered as a 0.1 mL intradermal injection

HCMV+ Placebo ID

Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6

Group Type PLACEBO_COMPARATOR

Placebo ID

Intervention Type OTHER

Placebo administered as a 0.1 mL intradermal injection

HCMV- Placebo ID

Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6

Group Type PLACEBO_COMPARATOR

Placebo ID

Intervention Type OTHER

Placebo administered as a 0.1 mL intradermal injection

Interventions

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V160 Low Dose IM

V160 administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

V160 Medium Dose IM

V160 administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

V160 High Dose IM

V160 administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM

V160 plus MAPA administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

V160 High Dose plus MAPA 225 µg /dose IM

V160 plus MAPA administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

V160 Maximum Dose IM

V160 administered as a 0.75 mL intramuscular injection

Intervention Type BIOLOGICAL

Placebo IM

Placebo administered as a 0.75 mL intramuscular injection

Intervention Type OTHER

V160 Medium Dose ID

V160 administered as a 0.1 mL intradermal injection

Intervention Type BIOLOGICAL

Placebo ID

Placebo administered as a 0.1 mL intradermal injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Germany United States

References

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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.

Reference Type DERIVED
PMID: 33031517 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31535143 (View on PubMed)

Other Identifiers

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V160-001

Identifier Type: -

Identifier Source: org_study_id