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

Completed · Phase 1

Conditions studied: Cytomegalovirus

In brief

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).

Key facts

Study ID

NCT01195571

Run by

CMV Research Foundation

People needed

36

Starts

2010-09-01

Expected to finish

2014-10-01

Last updated by the study team

2015-05-19

Who can join

Age: 30 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Significant acute or chronic infection at the time of vaccination.
• Household contact with an immunosuppressed individual.
• History of anaphylaxis or severe vaccine reaction.
• 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.
• Seropositive sexual partner who desires to become pregnant within one year following vaccination, currently is pregnant, or is currently breast feeding.
• Has a close contact who is CMV seronegative or who is ineligible or chooses not to participate in the study.
• Received blood products in proceeding three months or expects to receive blood products within the following year.
• A childcare provider.
• A health care provider who routinely comes in contact with pregnant women or immunologically compromised persons.
• Any condition which, in the opinion of the investigator, may interfere with adherence to the protocol or make it inadvisable to enroll the participant.
• Currently participating in a study of any other experimental or investigational agent, or has participated in such a study within a month of vaccination.
• Previous vaccination with an investigational HCMV vaccine.
• Treatment with excluded antiviral or immunosuppressive drugs (Appendix D) within one month prior to vaccination.
• Expected use of antiviral or immunosuppressive agents within two months following vaccination.
• 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).

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.