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

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.
ClinicalTrials.gov Identifier: NCT00201448
Recruitment Status : Terminated (Suspended due to lack of funding)
First Posted : September 20, 2005
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
CMV Research Foundation Inc
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Cytomegalovirus Infections
Interventions Biological: Hepatitis A Vaccine
Biological: Towne CMV Vaccine
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (Hepatitis A) Towne CMV Vaccine
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 42 40
Completed 42 40
Not Completed 0 0
Arm/Group Title Placebo (Hepatitis A) Towne CMV Vaccine Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 42 40 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
40
 100.0%
82
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 40 participants 82 participants
33  (4.5) 34  (5.6) 33.5  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 82 participants
Female
42
 100.0%
40
 100.0%
82
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 82 participants
Female
42
 100.0%
40
 100.0%
82
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 40 participants 82 participants
42 40 82
1.Primary Outcome
Title Participants With Adverse Events
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol and randomized
Arm/Group Title (Placebo) Hepatitis a Towne CMV Vaccine
Hide Arm/Group Description:
This is the comparator group.
[Not Specified]
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Immunology Response
Hide Description 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
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.
Arm/Group Title Placebo (Hepatitis A) Towne Vaccine
Hide Arm/Group Description:

Placebo group

Hepatitis A Vaccine: Single dose give IM

Towne vaccine given at 3000 pfu/subject

Towne CMV Vaccine: Single dose given subcutaneously

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Hepatitis A) Towne CMV Vaccine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (Hepatitis A) Towne CMV Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Hepatitis A) Towne CMV Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (Hepatitis A) Towne CMV Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stuart Adler
Organization: Virginia Commonwealth University
Phone: 8048281807
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00201448     History of Changes
Other Study ID Numbers: 94-078
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: April 3, 2012
Results First Posted: May 30, 2016
Last Update Posted: May 30, 2016