Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women

NCT00201448 | Terminated Phase 2 Results DMC

• 1 other identifier: 94-078
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children who attend daycare centers. Cytomegalovirus does not usually cause serious illness in adults and children. However, CMV can be a cause of deafness and mental retardation in a child born from a mother who has the infection during pregnancy. Women in the study will be given either cytomegalovirus or Hepatitis A vaccine. A blood sample will be taken before the vaccination is given. After vaccination, urine, saliva, and blood will be collected every 1-6 months for up to 3 years. Information regarding any reaction to the vaccination will be collected. All family members will be asked to provide urine and saliva to test for CMV every few months for up to 3 years. All children born to women who have been vaccinated will be tested for CMV infection. 180 women who are not infected with CMV will be vaccinated.

Conditions

Cytomegalovirus Infections

Keywords

CMV, cytomegalovirus, vaccine, Towne strain

Outcome Measures

Primary Outcomes (2)

• Participants With Adverse Events

  One year

• Immunology Response

  The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare

  Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.

Study Arms (2)

Placebo (hepatitis A)

ACTIVE COMPARATOR

Placebo group

Biological: Hepatitis A Vaccine

Towne vaccine

EXPERIMENTAL

Towne vaccine given at 3000 pfu/subject

Biological: Towne CMV Vaccine

Interventions

Hepatitis A Vaccine BIOLOGICAL

Single dose give IM

Placebo (hepatitis A)

Towne CMV Vaccine BIOLOGICAL

Single dose given subcutaneously

Towne vaccine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 18 and 45 years of age
• Good general health without significant physical examination findings
• With children \< 2 years old attending daycare centers
• Willingness to sign informed consent for screening and before enrollment
• Available to participate for the entire study period of 36 months
• Negative cytomegalovirus (CMV) serology
• Negative serum pregnancy test within two days prior to vaccination
• Willingness to have blood stored for future evaluations
• Willingness to have children provide saliva and urine samples
• Able to complete a demographic profile
• Agreement to practice effective contraception. Contraception is defined as using any of the following methods:
• Condoms (male or female)
• Diaphragm or cervical cap with spermicide
• Intrauterine device (IUD)
• Hormone contraception

You may not qualify if:

• Acute febrile illness (\>/=38C / 100.4F) within 72 hours preceding the vaccination (vaccination may be deferred until febrile illness is resolved, but a repeat pregnancy test will be required if deferred more than 48 hours.)
• Positive pregnancy test
• Breastfeeding
• Venous access deemed inadequate for the phlebotomy demands of the study
• Receipt of any vaccine, blood products, or investigational agents within 30 days prior to enrollment
• History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain
• History of immunodeficiency, autoimmune diseases, or malignancy
• History of severe cardiopulmonary diseases or serious metabolic disorders
• Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years
• Any acute or chronic condition (including alcohol or drug use) which in the opinion of the principle investigator would limit the volunteer's ability to complete the study

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• CMV Research Foundation Inc: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Stuart Adler
• Organization: Virginia Commonwealth University

sadler@vcu.edu

8048281807

Study Officials

• Stuart Adler, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 30, 2016
• Results First Posted: May 30, 2016

Record last verified: 2016-05

Locations

US (1)