Trial Outcomes & Findings for Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients (NCT NCT03525210)
NCT ID: NCT03525210
Last Updated: 2020-12-11
Results Overview
Seroconversion rates of neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58) one month after completion of a three doses schedule (0, 2 and 6 months) in patients seronegative at baseline for these antibodies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
271 participants
Primary outcome timeframe
7 months (for each subject)
Results posted on
2020-12-11
Participant Flow
This is a single center, open-label, investigator-initiated phase III study (protocol V503-044-IC, NCT03525210) in HIV patients and SOT recipients One hundred HIV patients (age: 18-45 years) and 171 SOT (kidney, heart, lung transplant) patients (age: 18-55 years) were enrolled between April 2018 and January 2019 in the outpatient clinic of the University Hospitals Leuven, Belgium
Participant milestones
| Measure |
HIV Patients
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
|
SOT Patients
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
171
|
|
Overall Study
COMPLETED
|
96
|
169
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients
Baseline characteristics by cohort
| Measure |
HIV Patients
n=100 Participants
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
|
SOT Patients
n=171 Participants
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
|
Total
n=271 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
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
46 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
100 participants
n=5 Participants
|
171 participants
n=7 Participants
|
271 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months (for each subject)Population: were seronegative to the appropriate HPV type at Day 1, had serology results based on acceptable day ranges and had no protocol deviations that could interfere with the subject's vaccine as judged by the principal investigator.
Seroconversion rates of neutralizing antibodies against each HPV vaccine genotypes (6/11/16/18/31/33/45/52/58) one month after completion of a three doses schedule (0, 2 and 6 months) in patients seronegative at baseline for these antibodies.
Outcome measures
| Measure |
HIV Patients
n=91 Participants
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and proportion of patients with adverse events.
|
SOT Patients
n=155 Participants
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and proportion of patients with adverse events.
|
|---|---|---|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 33
|
100 Percentage of participants
Interval 95.1 to 100.0
|
66.9 Percentage of participants
Interval 58.8 to 74.3
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV6
|
100 Percentage of participants
Interval 94.2 to 100.0
|
64.2 Percentage of participants
Interval 55.8 to 72.2
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV11
|
100 Percentage of participants
Interval 95.3 to 100.0
|
70.7 Percentage of participants
Interval 62.7 to 77.8
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 16
|
100 Percentage of participants
Interval 94.3 to 100.0
|
69.1 Percentage of participants
Interval 61.0 to 76.4
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 18
|
100 Percentage of participants
Interval 94.6 to 100.0
|
51.5 Percentage of participants
Interval 43.2 to 64.0
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 31
|
100 Percentage of participants
Interval 94.4 to 100.0
|
55.9 Percentage of participants
Interval 47.6 to 64.0
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 45
|
100 Percentage of participants
Interval 95.3 to 100.0
|
46.0 Percentage of participants
Interval 37.8 to 54.3
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 52
|
100 Percentage of participants
Interval 95.8 to 100.0
|
65.3 Percentage of participants
Interval 57.1 to 72.9
|
|
Seroconversion Following 3 Doses of 9-valent HPV Vaccines
Anti-HPV 58
|
100 Percentage of participants
Interval 94.9 to 100.0
|
72.0 Percentage of participants
Interval 64.1 to 79.0
|
SECONDARY outcome
Timeframe: 7 months (for each subject)Population: Patients with HIV or solid organ transplant who received at least one study vaccine and had at least one follow-up visit for AEs.
Number and percentage of subjects with local and systemic sollicited (up to 7 days following each vaccination) and unsollicited adverse events (up to 1 month after the 3rd HPV vaccine) will be analysed
Outcome measures
| Measure |
HIV Patients
n=99 Participants
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and proportion of patients with adverse events.
|
SOT Patients
n=170 Participants
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and proportion of patients with adverse events.
|
|---|---|---|
|
Adverse Reactions Following 9-valent HPV Vaccination
|
99 Participants
|
170 Participants
|
Adverse Events
HIV Patients
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
SOT Patients
Serious events: 28 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV Patients
n=99 participants at risk
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved.
|
SOT Patients
n=170 participants at risk
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Social circumstances
Burn-out
|
1.0%
1/99 • Number of events 1 • Time frame: 7 months
|
0.00%
0/170 • Time frame: 7 months
|
|
Psychiatric disorders
Alcohol Abuse
|
1.0%
1/99 • Number of events 1 • Time frame: 7 months
|
0.00%
0/170 • Time frame: 7 months
|
|
Injury, poisoning and procedural complications
Fracture tibia plateau
|
1.0%
1/99 • Number of events 1 • Time frame: 7 months
|
0.00%
0/170 • Time frame: 7 months
|
|
Gastrointestinal disorders
Abbdominal pain
|
0.00%
0/99 • Time frame: 7 months
|
1.2%
2/170 • Number of events 2 • Time frame: 7 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Infections and infestations
Fever without focus
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Infections and infestations
Gastro-intestinal infections
|
0.00%
0/99 • Time frame: 7 months
|
4.1%
7/170 • Number of events 7 • Time frame: 7 months
|
|
Infections and infestations
Respiratory infections
|
0.00%
0/99 • Time frame: 7 months
|
5.9%
10/170 • Number of events 10 • Time frame: 7 months
|
|
Infections and infestations
Skin infections
|
0.00%
0/99 • Time frame: 7 months
|
1.2%
2/170 • Number of events 2 • Time frame: 7 months
|
|
Infections and infestations
Generalized infections
|
0.00%
0/99 • Time frame: 7 months
|
1.2%
2/170 • Number of events 2 • Time frame: 7 months
|
|
Infections and infestations
Urogenital infection
|
0.00%
0/99 • Time frame: 7 months
|
1.8%
3/170 • Number of events 3 • Time frame: 7 months
|
|
Immune system disorders
Acute rejection transplant organ
|
—
0/0 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Metabolism and nutrition disorders
dysregulation glycemia
|
0.00%
0/99 • Time frame: 7 months
|
1.8%
3/170 • Number of events 3 • Time frame: 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse renal cell carcinoma
|
—
0/0 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis neck
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in transplant kidney
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemorrhage in adenohypophysis macroadenoma
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
|
Renal and urinary disorders
Pathology of the kidney
|
0.00%
0/99 • Time frame: 7 months
|
1.2%
2/170 • Number of events 2 • Time frame: 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory pathology
|
0.00%
0/99 • Time frame: 7 months
|
2.9%
5/170 • Number of events 5 • Time frame: 7 months
|
|
Vascular disorders
Ischemic stroke
|
0.00%
0/99 • Time frame: 7 months
|
0.59%
1/170 • Number of events 1 • Time frame: 7 months
|
Other adverse events
| Measure |
HIV Patients
n=99 participants at risk
All HIV patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved.
|
SOT Patients
n=170 participants at risk
All SOT patients will receive the study vaccines
9-valent HPV vaccine: Vaccination
Number and percentage of patients with adverse events. One patient stopped after the first dose and no safety information could be retrieved.
|
|---|---|---|
|
General disorders
Injection site pain
|
67.7%
67/99 • Number of events 67 • Time frame: 7 months
|
54.7%
93/170 • Number of events 93 • Time frame: 7 months
|
|
General disorders
Injection site swelling
|
7.1%
7/99 • Number of events 7 • Time frame: 7 months
|
8.2%
14/170 • Number of events 14 • Time frame: 7 months
|
|
General disorders
injection site erythema
|
10.1%
10/99 • Number of events 10 • Time frame: 7 months
|
5.9%
10/170 • Number of events 10 • Time frame: 7 months
|
|
Nervous system disorders
Headache
|
9.1%
9/99 • Number of events 9 • Time frame: 7 months
|
8.2%
14/170 • Number of events 14 • Time frame: 7 months
|
Additional Information
Head of Leuven University Vaccinology Center
KU Leuven / UZ Leuven
Phone: +32 16 321 078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place