AzTrials
AzTrials

DialysisPhase 1NCT02103426

An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

A Phase 1 study testing ASP0113 in people with Dialysis and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 4 sites in United States.

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

The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
ASP0113
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
4 sitesUnited States
Study dates
30 Dec 2013to 10 May 2016
Phase
Phase 1
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Main Inclusion for Healthy Subjects:
  • Body Mass Index (BMI) range of 18.5 - 35.0 kg/m2; weighs at least 50 kg at Screening.
  • Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 28 days after final injection.
  • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final injection.
  • Highly likely to comply with the protocol and complete the study.
  • Estimated creatinine clearance calculated using the Cockcroft-Gault equation of > 80 mL/min/1.73m2 (normal renal function).
Show all 13Show fewer
  • BMI range of 18.5 - 40.0 kg/m2; weighs at least 50 kg at Screening.
  • 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.
  • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
  • Must have adequate venous access.
  • Highly likely to comply with the protocol and complete the study.
  • Must currently be receiving hemodialysis treatment and for a period of at least 6 months prior to Screening.
  • CMV-seronegative at Screening.

Who cannot join

  • Main Exclusion Healthy Subjects
  • Female subject is pregnant at Screening.
  • Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
  • Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal (for healthy subjects only) and/or other major disease or malignancy (except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been handled by local surgery).
  • History or evidence of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, psoriasis, psoriatic arthritis and inflammatory bowel disease.
  • Febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (non-cutaneous) infection within 1 week prior to day -14.
Show all 44Show fewer
  • Any of the liver function tests (LFT) (aspartate amino-transferase [AST] or alanine aminotransferase [ALT] alkaline phosphatase (ALP), gamma-glutamyl transferase [GGT], total bilirubin [TBil]) outside of normal limits at Screening.
  • Mean pulse < 40 or > 90 beats per minute (bpm), mean systolic blood pressure (SBP) > 160 mmHg or mean diastolic blood pressure (DBP) > 90 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening.
  • Positive serology test for hepatitis B surface antigen (HBsAg) or hepatitis core immunoglobulin M (HBc [IgM]) antibody, anti-hepatitis A virus (HAV) IgM or anti-human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) at Screening.
  • Positive serology test for anti-hepatitis C virus (HCV) and a confirmatory positive reflex viral load test at Screening.
  • Current/ active CMV infection as evidenced by positive CMV Polymerase chain reaction (PCR) plasma results at Screening.
  • Any 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.
  • Use of any prescribed or non-prescribed drugs, alternative and complementary medications, except for vitamins, contraceptives, hormone replacement therapy and occasional acetaminophen (to a maximum of 2 g/day), within 14 days prior to first injection with ASP0113.
  • Vaccination with killed vaccines (including e.g., influenza and pneumococcal), or allergy treatment with antigen injections within 15 days prior to day -1.
  • Vaccination with live attenuated vaccines within 30 days prior to day -1.
  • Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to day 1.
  • 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 1ounce of spirits/hard liquor).
  • Positive test for alcohol or drugs of abuse at Screening or day -1.
  • Significant blood loss, donation of 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 -1.
  • Contraindication to an intramuscular (IM) injection.
  • Employee of the Astellas Group or contract research organization (CRO) involved.
  • Female subject is pregnant at Screening.
  • Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
  • 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.
  • 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.
  • Febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day-14.
  • 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.
  • 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.
  • 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.
  • Current/active CMV infection as evidenced by positive CMV PCR plasma results at Screening.
  • 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.
  • Use of alternative and complementary medications except for vitamins, within 14 days prior to first injection with ASP0113.
  • 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.
  • 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.
  • Vaccination with killed vaccines (including e.g., influenza and pneumococcal), or allergy treatment with antigen injections between the date of screening and day-1.
  • Vaccination with live attenuated vaccines within 30 days prior to day-1.
  • 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.
  • 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).
  • Positive test for alcohol or drugs of abuse (non-prescribed) at Screening or day -1.
  • 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.
  • Contraindication to an IM injection.
  • Employee of the Astellas Group or CRO involved in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Site US10001

    Baltimore, Maryland, 21225

  • Site US10004

    Houston, Texas, 77099

  • Site US10009

    Los Angeles, California, 90017

  • Site US10003

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Single-Blind, Parallel-Group, Pharmacokinetic and Immunogenicity Study With ASP0113 in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.

Read the detailed 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.

Being tested
ASP0113, Placebo
Keywords
Cytomegalovirus, ASP0113, CMV-seropositive, Healthy subjects, CMV-seronegative, Dialysis
Medical subject headings
Cytomegalovirus Infections

What participants receive

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

  • ASP0113Drug

    intramuscular injection

  • PlaceboDrug

    intramuscular injection

Study groups in NCT02103426
Study groupRoleWhat they receive
Part 1: ASP0113 CMV-seropositive healthy cohortExperimental5 mg single dose IM injection
Receives: Drug: ASP0113
Part 1: ASP0113 CMV-seronegative healthy cohortExperimental5 mg single dose IM injection
Receives: Drug: ASP0113
Part 1: Placebo CMV-seropositive healthy cohortPlacebo comparatorsingle dose IM injection
Receives: Drug: Placebo
Part 1: Placebo CMV-seronegative healthy cohortPlacebo comparatorsingle dose IM injection
Receives: Drug: Placebo
Part 2: ASP0113 CMV-seropositive healthy cohortExperimental4 IM injections of ASP0113
Receives: Drug: ASP0113
Part 2: ASP0113 CMV-seronegative healthy cohortExperimental4 IM injections of ASP0113
Receives: Drug: ASP0113
Part 2: ASP0113 CMV-seronegative dialysis cohortExperimental4 IM injections of ASP0113
Receives: Drug: ASP0113
Part 2: Placebo CMV-seropositive healthy cohortPlacebo comparator4 placebo IM injections
Receives: Drug: Placebo
Part 2: Placebo CMV-seronegative healthy cohortPlacebo comparator4 placebo IM injections
Receives: Drug: Placebo
Part 2: Placebo CMV-seronegative dialysis cohortPlacebo comparator4 placebo IM injections
Receives: Drug: Placebo

What is being measured

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

  1. ASP0113 plasmids pharmacokinetics in plasma: AUC (Part 1 and Part 2)

    Area under the curve (AUC)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2)

  2. ASP0113 plasmids pharmacokinetics in plasma: Cmax (Part 1 and Part 2)

    Maximum Concentration (Cmax)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2

  3. ASP0113 plasmids pharmacokinetics in plasma: Tmax (Part 1 and Part 2)

    Time to maximum concentration (Tmax)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2

  4. ASP0113 plasmids pharmacokinetics in plasma: Apparent clearance (Part 1 and Part 2)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2

  5. ASP0113 plasmids pharmacokinetics in plasma: apparent volume of distribution (Part 1 and Part 2)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2

  6. ASP0113 plasmids pharmacokinetics in plasma: half-life (Part 1 and Part 2)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2

  7. pp65 protein in white blood cells (WBCs) using pp65 antigenemia assay (Part 1 and Part 2)

    Measured: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 , 28 for Part 1; Day 1, 10, 14, weeks 5, 7, 9, 11, 25 and 27 for Part 2

  8. Immunogenicity: Relative units/ml of anti-gB antibodies in serum as detected by enzyme-linked immunosorbent assay (ELISA) (Part 2)

    Measured: Day 1 and weeks 3, 5, 7, 9, 11, 25 and 27 (Part 2)

  9. Immunogenicity: Number of pp65-specific Interferon (IFN)-gamma producing T-cells in isolated peripheral blood mononuclear cells (PBMCs) upon pp65 peptide stimulation as assayed by flow cytometry with intracellular cytokine staining (ICS) (Part 2)

    Measured: Day 1 and weeks 3, 5, 7, 9, 11, 25 and 27 (Part 2)

  10. Immunogenicity: Amount of IFN-gamma produced by CMV peptide-stimulated T-cells in whole blood using the QuantiFERON T-cell CMV assay (Part 2)

    Measured: Day 1 and weeks 3, 5, 7, 9, 11, 25 and 27 (Part 2)

  11. Safety assessed by clinical labs, vital signs, and adverse events including local and systemic reactogenicity

    Measured: Up to Day 28 (Part 1), Up to 7 months (Part 2)

Timeline

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

  1. First posted3 Apr 2014 (estimated)
  2. Study start30 Dec 2013
  3. Primary completion10 May 2016
  4. Study completion10 May 2016

Resources

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
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02103426
Sponsor's protocol ID
0113-CL-0004
Status last verified
Oct 2024
First submitted
1 Apr 2014
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP0113 in people with Dialysis and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 4 sites in United States.

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 13 inclusion and 44 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ASP0113 plasmids pharmacokinetics in plasma: AUC (Part 1 and Part 2) (time frame: Day 1, 2, 3, 4, 5, 6, 7, 10, 14, 21 and 28 for Part 1; Day 1, 2, 3, 4, 5, 6, 7 and weeks 5, 9 and 25 for Part 2)). The study lists 11 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 NCT02103426.

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 17 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in