Overview

This trial is active, not recruiting.

Condition cytomegalovirus infections
Treatments 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, v160 maximum dose im, placebo im, v160 medium dose id, placebo id
Phase phase 1
Sponsor Merck Sharp & Dohme Corp.
Start date November 2013
End date April 2016
Trial size 170 participants
Trial identifier NCT01986010, V160-001

Summary

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. Each treatment arm of 10 participants will be accompanied by a placebo arm of 4 participants. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 low dose im
V160 administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 low dose im
V160 administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 medium dose im
V160 administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 medium dose im
V160 administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 high dose im
V160 administered as a 0.75 mL intramuscular injection
(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
v160 medium dose plus merck aluminum phosphate adjuvant (mapa) 225 µg /dose im
V160 plus MAPA administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 high dose im
V160 administered as a 0.75 mL intramuscular injection
(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
v160 high dose plus mapa 225 µg /dose im
V160 plus MAPA administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 maximum dose im
V160 administered as a 0.75 mL intramuscular injection
(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
v160 high dose plus mapa 225 µg /dose im
V160 plus MAPA administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
v160 maximum dose im
V160 administered as a 0.75 mL intramuscular injection
(Placebo Comparator)
Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
placebo im
Placebo administered as a 0.75 mL intramuscular injection
(Placebo Comparator)
Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
placebo im
Placebo administered as a 0.75 mL intramuscular injection
(Experimental)
Participants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
v160 medium dose id
V160 administered as a 0.1 mL intradermal injection
(Experimental)
Participants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
v160 medium dose id
V160 administered as a 0.1 mL intradermal injection
(Placebo Comparator)
Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
placebo id
Placebo administered as a 0.1 mL intradermal injection
(Placebo Comparator)
Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
placebo id
Placebo administered as a 0.1 mL intradermal injection

Primary Outcomes

Measure
Percentage of Participants with an Adverse Event (AE)
time frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6)
Percentage of Participants with an Injection-site AE
time frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6)
Percentage of Participants with a Systemic AE
time frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6)
Percentage of Participants with a Serious Adverse Event (SAE)
time frame: From the time of vaccination up to 14 days after any vaccination (vaccinations are administered on Day 1, Month 1 and Month 6)
Geometric Mean Titer of HCMV-specific Neutralizing Antibody
time frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6)

Secondary Outcomes

Measure
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
time frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6)
Geometric Mean Concentration of Interferon-Gamma after Stimulation of Whole Blood Sample with Pooled HCMV Antigen Peptides
time frame: 1 month after vaccination 3 (vaccination 3 is administered at Month 6)

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..