PatientsVille.com LogoPatientsVille.com

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

Cytomegalovirus Infections research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cytomegalovirus Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:V160 Low Dose IMV160 administered as a 0.75 mL intramuscular injection

Biological:V160 Medium Dose IMV160 administered as a 0.75 mL intramuscular injection

Biological:V160 High Dose IMV160 administered as a 0.75 mL intramuscular injection

Biological:V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IMV160 plus MAPA administered as a 0.75 mL intramuscular injection

Biological:V160 High Dose plus MAPA 225 µg /dose IMV160 plus MAPA administered as a 0.75 mL intramuscular injection

Biological:V160 Maximum Dose IMV160 administered as a 0.75 mL intramuscular injection

Other:Placebo IMPlacebo administered as a 0.75 mL intramuscular injection

Biological:V160 Medium Dose IDV160 administered as a 0.1 mL intradermal injection

Other:Placebo IDPlacebo administered as a 0.1 mL intradermal injection

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

HCMV seronegative (-) 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 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 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 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 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 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 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 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 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 IMParticipants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

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

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

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

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

Study Status

Completed

Start Date: November 25, 2013

Completed Date: March 14, 2017

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Percentage of Participants with an Adverse Event (AE)

Secondary Outcome: Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma

Study sponsors, principal investigator, and references

Principal Investigator: Medical Director

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01986010

Discuss Aluminium