Trial Outcomes & Findings for Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors (NCT NCT00353977)
NCT ID: NCT00353977
Last Updated: 2014-07-08
Results Overview
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.
COMPLETED
PHASE2
38 participants
Day 45
2014-07-08
Participant Flow
Hematopoietic stem cell transplant (sibling) donors and normal volunteers at a quaternary hospital. Recruitment: 3/05 to 11/06
Participant milestones
| Measure |
Alvac pp65 Vaccine
Subjects received 2 or 3 doses of the vaccine
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
Baseline characteristics by cohort
| Measure |
Alvac pp65 Vaccine
n=38 Participants
Subjects received 2 or 3 doses of the vaccine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13 • n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 45Population: 11 subjects were CMV seropositive and 3 subjects were seronegative.
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.
Outcome measures
| Measure |
Alvac pp65 Vaccine
n=14 Participants
Subjects received 2 or 3 doses of the vaccine
|
|---|---|
|
Cellular Immune Response in Vaccine Recipients
|
14 participants
|
Adverse Events
Alvac pp65 Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alvac pp65 Vaccine
n=38 participants at risk
Subjects received 1, 2 or 3 doses of the vaccine
|
|---|---|
|
Cardiac disorders
hypotension
|
2.6%
1/38 • Number of events 1
|
|
General disorders
chills
|
2.6%
1/38 • Number of events 1
|
|
General disorders
diaphoresis
|
2.6%
1/38 • Number of events 1
|
|
General disorders
fatigue
|
13.2%
5/38 • Number of events 5
|
|
General disorders
malaise
|
7.9%
3/38 • Number of events 3
|
|
General disorders
rigors
|
2.6%
1/38 • Number of events 1
|
|
General disorders
weakness
|
5.3%
2/38 • Number of events 2
|
|
General disorders
nausea
|
2.6%
1/38 • Number of events 1
|
|
Blood and lymphatic system disorders
swollen lymph nodes, axillary
|
10.5%
4/38 • Number of events 4
|
|
Nervous system disorders
dizziness
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
tingling, fingers
|
2.6%
1/38 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.3%
2/38 • Number of events 2
|
|
General disorders
myalgia
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
headache
|
21.1%
8/38 • Number of events 8
|
|
General disorders
fever
|
5.3%
2/38 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place