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

NCT01195571 | Completed Phase 1 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  2 years

Study Arms (1)

vaccine administration

NO INTERVENTION

Each subject will receive on of four chimera CMV vaccines

Biological: cmv vaccine

Interventions

cmv vaccine BIOLOGICAL

dose escalation study of 4 towne-toledo chimera vaccines

Also known as: Towne vaccine, Toledo vaccine

vaccine administration

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• CMV Research Foundation: lead
• International AIDS Vaccine Initiative: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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. doi: 10.1093/infdis/jiw365. Epub 2016 Aug 11.

  PMID: 27521362 DERIVED

MeSH Terms

Interventions

mRNA-1647 cytomegalovirus vaccine

Study Officials

• Stuart P Adler, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

US (1)