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Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors

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ClinicalTrials.gov Identifier: NCT00353977
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cytomegalovirus Infections
Intervention Biological: ALVAC-CMV (vCP260)
Enrollment 38
Recruitment Details

Hematopoietic stem cell transplant (sibling) donors and normal volunteers at a quaternary hospital.

Recruitment: 3/05 to 11/06

Pre-assignment Details  
Arm/Group Title Alvac pp65 Vaccine
Hide Arm/Group Description Subjects received 2 or 3 doses of the vaccine
Period Title: Overall Study
Started 38
Completed 38
Not Completed 0
Arm/Group Title Alvac pp65 Vaccine
Hide Arm/Group Description Subjects received 2 or 3 doses of the vaccine
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
37
  97.4%
>=65 years
1
   2.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
39  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
20
  52.6%
Male
18
  47.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Cellular Immune Response in Vaccine Recipients
Hide Description Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.
Time Frame Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
11 subjects were CMV seropositive and 3 subjects were seronegative.
Arm/Group Title Alvac pp65 Vaccine
Hide Arm/Group Description:
Subjects received 2 or 3 doses of the vaccine
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alvac pp65 Vaccine
Hide Arm/Group Description Subjects received 1, 2 or 3 doses of the vaccine
All-Cause Mortality
Alvac pp65 Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alvac pp65 Vaccine
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Alvac pp65 Vaccine
Affected / at Risk (%) # Events
Total   14/38 (36.84%)    
Blood and lymphatic system disorders   
swollen lymph nodes, axillary *  4/38 (10.53%)  4
Cardiac disorders   
hypotension *  1/38 (2.63%)  1
General disorders   
chills *  1/38 (2.63%)  1
diaphoresis *  1/38 (2.63%)  1
fatigue *  5/38 (13.16%)  5
malaise *  3/38 (7.89%)  3
rigors *  1/38 (2.63%)  1
weakness *  2/38 (5.26%)  2
nausea *  1/38 (2.63%)  1
myalgia *  2/38 (5.26%)  2
fever *  2/38 (5.26%)  2
Musculoskeletal and connective tissue disorders   
arthralgia *  2/38 (5.26%)  2
Nervous system disorders   
dizziness *  2/38 (5.26%)  2
tingling, fingers *  1/38 (2.63%)  1
headache *  8/38 (21.05%)  8
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Minoo Battiwalla, MD
Organization: Hematology Branch, NHLBI
Phone: 301 827 0939
Responsible Party: Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00353977     History of Changes
Other Study ID Numbers: 040198
04-H-0198 ( Other Identifier: National Heart Lung and Blood Institute )
First Submitted: July 18, 2006
First Posted: July 19, 2006
Results First Submitted: April 30, 2013
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014