Recruitment

Recruitment Status
Completed
Estimated Enrollment
46

Inclusion Criteria

Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 30 days after final injection.
Must currently be receiving hemodialysis treatment and for a period of at least 6 months prior to Screening.
...
Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 30 days after final injection.
Must currently be receiving hemodialysis treatment and for a period of at least 6 months prior to Screening.
CMV-seronegative at Screening.
Highly likely to comply with the protocol and complete the study.
Must have adequate venous access.
BMI range of 18.5 - 40.0 kg/m2; weighs at least 50 kg at Screening.

Exclusion Criteria

Current/active CMV infection as evidenced by positive CMV PCR plasma results at Screening.
Mean pulse < 40 or > 100 bpm or mean SBP > 180 mmHg; mean DBP > 100 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening.
Employee of the Astellas Group or CRO involved in the study.
...
Current/active CMV infection as evidenced by positive CMV PCR plasma results at Screening.
Mean pulse < 40 or > 100 bpm or mean SBP > 180 mmHg; mean DBP > 100 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening.
Employee of the Astellas Group or CRO involved in the study.
Positive test for alcohol or drugs of abuse (non-prescribed) at Screening or day -1.
Hemoglobin < 9 g/dL, TBil greater than the upper limit of normal (ULN), or an AST or ALT greater than 2 x the ULN at Screening. In such cases the assessment may be repeated once.
History of consuming more than 14 units of alcoholic beverages per week within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
Significant blood loss, donated 1 unit (450 mL) or more of blood or receipt of a transfusion of any blood, blood products or plasma within 90 days of day -14.
Positive serology test for HBsAg or HBc (IgM), anti HAV (IgM), anti-HIV-1 or anti-HIV-2 at Screening.
Positive serology test for anti-HCV and a confirmatory positive reflex viral load test at Screening.
Any history or evidence of any unstable, clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, pulmonary, neurologic, dermatologic, psychiatric and/or other major disease or malignancy.
Female subject is pregnant at Screening.
Vaccination with live attenuated vaccines within 30 days prior to day-1.
Use of alternative and complementary medications except for vitamins, within 14 days prior to first injection with ASP0113.
Febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day-14.
Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
Known or suspected hypersensitivity to ASP0113 or any components of the formulation used, including aminoglycosides as kanamycin is used during the manufacturing of the vaccine.
Participated in any interventional clinical study or treatment with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to day 1.
Vaccination with killed vaccines (including e.g., influenza and pneumococcal), or allergy treatment with antigen injections between the date of screening and day-1.
Contraindication to an IM injection.
Use of anticoagulants, including, but not limited to, vitamin K antagonists, heparin or its derivatives, low molecular weight heparin, factor X inhibitors or thrombin inhibitors within 5 half-lives of the first ASP0113 injection. Low dose anticoagulants used for prevention of deep vein thrombosis, prevention of fistula clotting, prevention of cardiovascular clotting, and heparin for use with dialysis procedure will be allowed after review and approval from the medical monitor.
History of prior organ transplant, including a kidney, unless the transplant was unsuccessful and the subject is no longer receiving immunosuppressive therapy.
History or evidence of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, psoriasis, psoriatic arthritis and inflammatory bowel disease or other disease which may require use of an immunosuppressant medication during the trial.
Subject has had use of any immunosuppressive drugs, including but not limited to, systemic corticosteroids within 14 days or 5 half-lives of initial injection, whichever is longer. History of topical or inhaled corticosteroid use should be discussed with the Medical Monitor for evaluation.

Summary

Conditions
  • Cytomegalovirus Infection
  • Dialysis
  • Healthy Subjects
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

Part 1 is open-label with no randomization, and Part 2 is single-blind and randomized. The purpose of Part 1 is to obtain pilot pharmacokinetic data so as to optimize pharmacokinetic sample collection times in Part 2.

Part 1 is open-label with no randomization, and Part 2 is single-blind and randomized. The purpose of Part 1 is to obtain pilot pharmacokinetic data so as to optimize pharmacokinetic sample collection times in Part 2.

Inclusion Criteria

Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 30 days after final injection.
Must currently be receiving hemodialysis treatment and for a period of at least 6 months prior to Screening.
...
Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 30 days after final injection.
Must currently be receiving hemodialysis treatment and for a period of at least 6 months prior to Screening.
CMV-seronegative at Screening.
Highly likely to comply with the protocol and complete the study.
Must have adequate venous access.
BMI range of 18.5 - 40.0 kg/m2; weighs at least 50 kg at Screening.

Exclusion Criteria

Current/active CMV infection as evidenced by positive CMV PCR plasma results at Screening.
Mean pulse < 40 or > 100 bpm or mean SBP > 180 mmHg; mean DBP > 100 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening.
Employee of the Astellas Group or CRO involved in the study.
...
Current/active CMV infection as evidenced by positive CMV PCR plasma results at Screening.
Mean pulse < 40 or > 100 bpm or mean SBP > 180 mmHg; mean DBP > 100 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening.
Employee of the Astellas Group or CRO involved in the study.
Positive test for alcohol or drugs of abuse (non-prescribed) at Screening or day -1.
Hemoglobin < 9 g/dL, TBil greater than the upper limit of normal (ULN), or an AST or ALT greater than 2 x the ULN at Screening. In such cases the assessment may be repeated once.
History of consuming more than 14 units of alcoholic beverages per week within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
Significant blood loss, donated 1 unit (450 mL) or more of blood or receipt of a transfusion of any blood, blood products or plasma within 90 days of day -14.
Positive serology test for HBsAg or HBc (IgM), anti HAV (IgM), anti-HIV-1 or anti-HIV-2 at Screening.
Positive serology test for anti-HCV and a confirmatory positive reflex viral load test at Screening.
Any history or evidence of any unstable, clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, pulmonary, neurologic, dermatologic, psychiatric and/or other major disease or malignancy.
Female subject is pregnant at Screening.
Vaccination with live attenuated vaccines within 30 days prior to day-1.
Use of alternative and complementary medications except for vitamins, within 14 days prior to first injection with ASP0113.
Febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day-14.
Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
Known or suspected hypersensitivity to ASP0113 or any components of the formulation used, including aminoglycosides as kanamycin is used during the manufacturing of the vaccine.
Participated in any interventional clinical study or treatment with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to day 1.
Vaccination with killed vaccines (including e.g., influenza and pneumococcal), or allergy treatment with antigen injections between the date of screening and day-1.
Contraindication to an IM injection.
Use of anticoagulants, including, but not limited to, vitamin K antagonists, heparin or its derivatives, low molecular weight heparin, factor X inhibitors or thrombin inhibitors within 5 half-lives of the first ASP0113 injection. Low dose anticoagulants used for prevention of deep vein thrombosis, prevention of fistula clotting, prevention of cardiovascular clotting, and heparin for use with dialysis procedure will be allowed after review and approval from the medical monitor.
History of prior organ transplant, including a kidney, unless the transplant was unsuccessful and the subject is no longer receiving immunosuppressive therapy.
History or evidence of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, psoriasis, psoriatic arthritis and inflammatory bowel disease or other disease which may require use of an immunosuppressant medication during the trial.
Subject has had use of any immunosuppressive drugs, including but not limited to, systemic corticosteroids within 14 days or 5 half-lives of initial injection, whichever is longer. History of topical or inhaled corticosteroid use should be discussed with the Medical Monitor for evaluation.

Tracking Information

NCT #
NCT02103426
Collaborators
Vical
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.
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