Trial Outcomes & Findings for Gardasil Vaccination in Post Stem Cell Transplant Patients (NCT NCT01092195)
NCT ID: NCT01092195
Last Updated: 2019-08-06
Results Overview
The percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
12 months
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
Transplant With Immunosuppression
Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Transplant With no Immunosuppression
Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Healthy Volunteer
Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
20
|
|
Overall Study
COMPLETED
|
23
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gardasil Vaccination in Post Stem Cell Transplant Patients
Baseline characteristics by cohort
| Measure |
Transplant With Immunosuppression
n=23 Participants
Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Transplant With no Immunosuppression
n=21 Participants
Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Healthy Volunteer
n=20 Participants
Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.
Outcome measures
| Measure |
Transplant With Immunosuppression
n=23 Participants
Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Transplant With no Immunosuppression
n=21 Participants
Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Healthy Volunteer
n=20 Participants
Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
|---|---|---|---|
|
Percentage of Subjects Who Developed Antibody Response to the Vaccine.
|
18 Participants
|
20 Participants
|
20 Participants
|
Adverse Events
Transplant With Immunosuppression
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Transplant With no Immunosuppression
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Healthy Volunteer
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transplant With Immunosuppression
n=23 participants at risk
Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Transplant With no Immunosuppression
n=21 participants at risk
Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
Healthy Volunteer
n=20 participants at risk
Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.
|
|---|---|---|---|
|
General disorders
Pain
|
69.6%
16/23 • 12 months
|
66.7%
14/21 • 12 months
|
100.0%
20/20 • 12 months
|
|
General disorders
Swelling
|
26.1%
6/23 • 12 months
|
0.00%
0/21 • 12 months
|
20.0%
4/20 • 12 months
|
|
General disorders
Erythema
|
26.1%
6/23 • 12 months
|
9.5%
2/21 • 12 months
|
25.0%
5/20 • 12 months
|
|
General disorders
Pruritus
|
13.0%
3/23 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Rash
|
4.3%
1/23 • 12 months
|
14.3%
3/21 • 12 months
|
10.0%
2/20 • 12 months
|
|
General disorders
Headache
|
4.3%
1/23 • 12 months
|
23.8%
5/21 • 12 months
|
5.0%
1/20 • 12 months
|
|
General disorders
Pyrexia
|
8.7%
2/23 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Fatigue
|
30.4%
7/23 • 12 months
|
19.0%
4/21 • 12 months
|
20.0%
4/20 • 12 months
|
|
General disorders
Edema
|
8.7%
2/23 • 12 months
|
9.5%
2/21 • 12 months
|
0.00%
0/20 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place