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Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195571
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : May 19, 2015
International AIDS Vaccine Initiative
Information provided by (Responsible Party):
Stuart P. Adler, CMV Research Foundation

Tracking Information
First Submitted Date  ICMJE September 2, 2010
First Posted Date  ICMJE September 6, 2010
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2010)
Safety [ Time Frame: 2 years ]
To evaluate the safety and tolerability, in adults without prior HCMV immunity (seronegative), of four live attenuated HCMV investigational vaccines at each of three dose levels.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01195571 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
Official Title  ICMJE A Dose Escalation Study to Assess the Safety and Immunogenicity of Four Live Attenuated Human Cytomegalovirus(HCMV) Vaccines in Healthy Adults Without Prior Immunity.
Brief Summary The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the United States by the age of twenty-one. CMV does not usually cause illness in adults or children. However, CMV can be a cause of deafness and mental retardation in a child if a mother is infected during pregnancy. It also can be a serious illness in patients with impaired immunity (decreased ability to fight infection).
Detailed Description A total of thirty six participants will be enrolled. The first 12 participants will be randomized into four groups. Four groups will receive one of the four investigational vaccines. The four investigational HCMV vaccine candidates will be administered subcutaneously to 3 volunteers at 10 pfu (the lowest dose to be used). The safety and tolerability of the four investigational HCMV vaccine candidates will be monitored closely for a period of 12 weeks following vaccination at this dose. Investigational vaccines that are found to be safe and well tolerated at a dose of 10pfu will be administered to 3 additional individuals at 102 pfu and then at 103 pfu. Safety and tolerability will be evaluated at each dose level by monitoring clinical signs and symptoms, laboratory parameters and virus detection in the blood, urine, and saliva. After the 12-week safety-monitoring period, participants will be followed for the remainder of one year to assess long-term safety and immunogenicity of the investigational vaccines.
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cytomegalovirus
Intervention  ICMJE Biological: cmv vaccine
dose escalation study of 4 towne-toledo chimera vaccines
Other Names:
  • Towne vaccine
  • Toledo vaccine
Study Arms No Intervention: vaccine administration
Each subject will receive on of four chimera CMV vaccines
Intervention: Biological: cmv vaccine
Publications * Adler SP, Manganello AM, Lee R, McVoy MA, Nixon DE, Plotkin S, Mocarski E, Cox JH, Fast PE, Nesterenko PA, Murray SE, Hill AB, Kemble G. A Phase 1 Study of 4 Live, Recombinant Human Cytomegalovirus Towne/Toledo Chimera Vaccines in Cytomegalovirus-Seronegative Men. J Infect Dis. 2016 Nov 1;214(9):1341-1348. Epub 2016 Aug 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • a) Healthy male adult, between the ages of 30 to 50 years with no children <18 years of age at home and in a stable sexual or household relationship with an individual who must be CMV seropositive, non-pregnant, not planning a pregnancy within one year and not currently breastfeeding.

    b) HCMV seronegative. c) HIV seronegative. d) Hepatitis B surface antigen negative. e) No evidence of active hepatitis C infection by serologic evaluation. f) HCMV culture negative (to be determined by shell vial or routine culture of urine, blood and saliva collected at the screening visit).

    g) Agrees to abstain from sex or to use condoms during intercourse for 52 weeks following vaccination.

    h) Available by telephone or pager for one year following vaccination. i) Willing and able to comply with the requirements of the protocol and to properly complete participant diaries.

    j) Signed informed consent and completed social/demographic questionnaire. k) Willing to forego blood, bone marrow or whole organ donation for 1year post vaccination.

    l) Willing to forego enrollment in studies of other investigational agents for one year following vaccination.

Exclusion Criteria:

  1. History of immunodeficiency or any ongoing serious disease such as cancer, autoimmune disease, HIV infection, chronic renal failure (whether or not on dialysis), or diabetes.
  2. Significant acute or chronic infection at the time of vaccination.
  3. Household contact with an immunosuppressed individual.
  4. History of anaphylaxis or severe vaccine reaction.
  5. Vaccination with a live vaccine within the past month or an inactivated vaccine within two weeks prior to vaccination, or plan to receive any vaccine within two months following vaccination.
  6. Seropositive sexual partner who desires to become pregnant within one year following vaccination, currently is pregnant, or is currently breast feeding.
  7. Has a close contact who is CMV seronegative or who is ineligible or chooses not to participate in the study.
  8. Received blood products in proceeding three months or expects to receive blood products within the following year.
  9. A childcare provider.
  10. A health care provider who routinely comes in contact with pregnant women or immunologically compromised persons.
  11. Any condition which, in the opinion of the investigator, may interfere with adherence to the protocol or make it inadvisable to enroll the participant.
  12. Currently participating in a study of any other experimental or investigational agent, or has participated in such a study within a month of vaccination.
  13. Previous vaccination with an investigational HCMV vaccine.
  14. Treatment with excluded antiviral or immunosuppressive drugs (Appendix D) within one month prior to vaccination.
  15. Expected use of antiviral or immunosuppressive agents within two months following vaccination.
  16. Any screening safety laboratory value that is outside normal limits of the laboratory normal range (screening laboratory tests may be repeated if minor abnormalities or possible laboratory errors are noted).

Sexes Eligible for Study: Male
Ages 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01195571
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stuart P. Adler, CMV Research Foundation
Study Sponsor  ICMJE CMV Research Foundation
Collaborators  ICMJE International AIDS Vaccine Initiative
Investigators  ICMJE
Principal Investigator: Stuart P Adler, MD Virginia Commonwealth University
PRS Account CMV Research Foundation
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP