Status:
COMPLETED
Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
Lead Sponsor:
CMV Research Foundation
Collaborating Sponsors:
International AIDS Vaccine Initiative
Conditions:
Cytomegalovirus
Eligibility:
MALE
30-50 years
Phase:
PHASE1
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 ne...
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 investig...
Eligibility Criteria
Inclusion
- 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
- 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).
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Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01195571
Start Date
September 1 2010
End Date
October 1 2014
Last Update
May 19 2015
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298