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Clinical Trial Results:
An Open-label phase III study to investigate the safety, tolerability and immunogenicity of a nine-valent human papillomavirus (HPV) vaccine (Gardasil®9) in solid organ transplant recipients and HIV-infected patients

Summary
EudraCT number	2017-004322-15
Trial protocol	BE
Global end of trial date	24 Jun 2020

Results information
Results version number	v1(current)
This version publication date	05 Apr 2022
First version publication date	05 Apr 2022
Other versions
Summary report(s)	Publication HPV vaccination in immunocompromized patients

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

V503-044-IC

ISRCTN number

US NCT number

NCT03525210

WHO universal trial number (UTN)

Sponsor organisation name

UZ Leuven

Sponsor organisation address

Herestraat 49, Leuven, Belgium, 3000

Public contact

Leuven University Vaccinology Cente, KU Leuven, 32 16342020, lise.boey@kuleuven.be

Scientific contact

Leuven University Vaccinology Cente, KU Leuven, 32 16342020, lise.boey@kuleuven.be

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

11 Dec 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

11 Dec 2019

Global end of trial reached?

Yes

Global end of trial date

24 Jun 2020

Was the trial ended prematurely?

Main objective of the trial

To determine the immunogenicity of Gardasil®9 with respect to HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 in adult HIV (age: 18-45 years) and transplant patients (age: 18-55 years).

Protection of trial subjects

Patients with immunodeficiencies are at increased risk of developing persistent HPV infection and as such HPV-related disease (genital warts and cancer). In this study HIV-patients and SOT-patients received 3 doses of Gardasil®9. Safety, tolerability and immunogenicity will be evaluated up to one month following the 3rd and last dose of Gardasil®9. Studies with other HPV vaccines (quadrivalent HPV vaccine Gardasil and bivalent HPV vaccine Cervarix) were already administered without safety issues in this specific patients population.

Background therapy

Immunosuppressive medication in case of patients with transplant and retroviral therapy in case of patients living with HIV.

Evidence for comparator

Actual start date of recruitment

08 Jan 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 271

Worldwide total number of subjects

271

EEA total number of subjects

271

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

271

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

One hundred HIV-infected persons (age 18–45 years) and 171 SOT (kidney, heart, lung transplant) recipients (age 18–55 years) were enrolled between April 2018 and January 2019 in the outpatient clinic of the University Hospitals Leuven, Belgium.

Screening details

Independent Ethics Committee (IEC)-approved written informed consent form (ICF) must be obtained from the subject prior to any study-related procedures Subject (man or woman) is between the age of 18 years and <46 years for HIV patients (have CD4+ T cell count of >200 cells/mm²), between 18 years and <56 years for transplant patients (>12 months)

Number of subjects started

271

Number of subjects completed

271

Period 1 title

Vaccination period (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

Blinding was not necessary as all patients received the HPV vaccine and control group was historical healthy subjects

Are arms mutually exclusive

Yes

Patients living with HIV

Arm description

HIV patients: have CD4+ T cell count of >200 cells/mm² at the last control (less than 12 months ago).

Arm type

Experimental

Investigational medicinal product name

Gardasil9

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Humaan papillomavirus1 type 6-L1-eiwit2,3 - 30 microgram Humaan papillomavirus1 type 11-L1-eiwit2,3 - 40 microgram Humaan papillomavirus1 type 16-L1-eiwit2,3 - 60 microgram Humaan papillomavirus1 type 18-L1-eiwit2,3 - 40 microgram Humaan papillomavirus1 type 31-L1-eiwit2,3 - 20 microgram Humaan papillomavirus1 type 33-L1-eiwit2,3 - 20 microgram Humaan papillomavirus1 type 45-L1-eiwit2,3 - 20 microgram Humaan papillomavirus1 type 52-L1-eiwit2,3 - 20 microgram Humaan papillomavirus1 type 58-L1-eiwit2,3 - 20 microgram Administration through intramuscular injection in the deltoid muscle

Patients after SOT-transplantation (heart, lung or kidney)

Arm description

Solid-Organ-Transplant patients received their organ transplantation ≥12 months prior to vaccination and has been stable in the past 6 months (i.e. no acute rejection or other immunological reactions).

Arm type

Experimental

Investigational medicinal product name

Gardasil9

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Number of subjects in period 1	Patients living with HIV	Patients after SOT-transplantation (heart, lung or kidney)
Started	100	171
Completed	96	169
Not completed	4	2
Consent withdrawn by subject	4	2

Baseline characteristics

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Reporting group title

Patients living with HIV

Reporting group description

HIV patients: have CD4+ T cell count of >200 cells/mm² at the last control (less than 12 months ago).

Reporting group title

Patients after SOT-transplantation (heart, lung or kidney)

Reporting group description

Reporting group values	Patients living with HIV	Patients after SOT-transplantation (heart, lung or kidney)	Total
Number of subjects	100	171	271
Age categorical
Subject (man or woman) is between the age of 18 years and 0 days and 45 years and 365 days for HIV patients, between 18 years and 0 days and 55 years and 365 days for transplant patients at time of signing the ICF
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	100	171	271
From 65-84 years	0	0	0
85 years and over	0	0	0
Gender categorical
Units: Subjects
Female	15	53	68
Male	85	118	203
Race
Race (Caucasian or African Black) was collected as additional study specific baseline characteristics
Units: Subjects
Caucasian	68	168	236
African Black	23	2	25
Other	9	1	10

End points

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Reporting group title

Patients living with HIV

Reporting group description

HIV patients: have CD4+ T cell count of >200 cells/mm² at the last control (less than 12 months ago).

Reporting group title

Patients after SOT-transplantation (heart, lung or kidney)

Reporting group description

Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines

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End point title

Seroconversion Following 3 Doses of 9-valent HPV Vaccines

End point description

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: subjects who 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.

End point type

Primary

End point timeframe

7 months

End point values	Patients living with HIV	Patients after SOT-transplantation (heart, lung or kidney)
Number of subjects analysed	91	155
Units: number of subjects
HPV type 6	91	100
HPV type 11	91	110
HPV type 16	91	107
HPV type 18	91	80
HPV type 31	91	87
HPV type 33	91	104
HPV type 45	91	71
HPV type 52	91	101
HPV type 58	91	112

Seroconversion rates

Statistical analysis description

The geometric mean titers (GMT) and seroconversion rates are only descriptive. The 95% CIs were calculated based on the exact binomial disribution (binomial test) for seroconversion rate, and parametric with T-distribution for the log transformed antibody titers ( and afterward transformed again to the metric scale).

Comparison groups

Patients living with HIV v Patients after SOT-transplantation (heart, lung or kidney)

Number of subjects included in analysis

246

Analysis specification

Pre-specified

Analysis type

other ^[1]

P-value

≤ 0.05

Method

Regression, Logistic

Parameter type

regression coefficient

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard deviation

Notes
[1] - This was a descriptive study in which we did not use a control group and only one vaccine was used. We did try to see whether factors would have an impact on the immune response

Adverse events

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Timeframe for reporting adverse events

From Day 1 to 1 month post-dose 3 (or approximately one month following the third and last HPV vaccine dose

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Patients with HIV

Reporting group description

Reporting group title

Patients after SOT

Reporting group description

Serious adverse events	Patients with HIV	Patients after SOT
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 99 (3.03%)	28 / 170 (16.47%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse renal cell carcinoma
subjects affected / exposed ^[1]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cyst in transplant kidney
subjects affected / exposed ^[2]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemorrhage in adenohypophysis in macroadenoma
subjects affected / exposed ^[3]	0 / 1 (0.00%)	1 / 170 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Ischaemic stroke
subjects affected / exposed ^[4]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Acute rejection transplant organ
subjects affected / exposed ^[5]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Burnout syndrome
subjects affected / exposed ^[6]	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory pathology
subjects affected / exposed ^[7]	0 / 1 (0.00%)	5 / 5 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Alcohol abuse
subjects affected / exposed ^[8]	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fracture tibia plateau
subjects affected / exposed ^[9]	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial flutter
subjects affected / exposed ^[10]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia paroxysmal
subjects affected / exposed ^[11]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed ^[12]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
abdominal pain
subjects affected / exposed ^[13]	0 / 1 (0.00%)	2 / 2 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed ^[14]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Pathology of the kidney
subjects affected / exposed ^[15]	0 / 1 (0.00%)	2 / 2 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthrosis neck
subjects affected / exposed ^[16]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Fever without focus
subjects affected / exposed ^[17]	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastro-intestinal infections
subjects affected / exposed ^[18]	0 / 1 (0.00%)	7 / 7 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory infections
subjects affected / exposed ^[19]	0 / 1 (0.00%)	10 / 10 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Skin infections
subjects affected / exposed ^[20]	0 / 1 (0.00%)	2 / 2 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Generalized infections
subjects affected / exposed ^[21]	0 / 1 (0.00%)	2 / 2 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urogenital infections
subjects affected / exposed ^[22]	0 / 1 (0.00%)	3 / 3 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dysregulation glycemia
subjects affected / exposed ^[23]	0 / 1 (0.00%)	3 / 3 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Patients with HIV	Patients after SOT
Total subjects affected by non serious adverse events
subjects affected / exposed	80 / 99 (80.81%)	127 / 170 (74.71%)
Nervous system disorders
Headache
subjects affected / exposed ^[24]	9 / 9 (100.00%)	14 / 14 (100.00%)
occurrences all number	9	14
General disorders and administration site conditions
Injection site pain
alternative assessment type: Non-systematic
subjects affected / exposed ^[25]	67 / 67 (100.00%)	93 / 93 (100.00%)
occurrences all number	67	93
Injection site swelling
subjects affected / exposed ^[26]	7 / 7 (100.00%)	14 / 14 (100.00%)
occurrences all number	7	14
Injection site erythema
subjects affected / exposed ^[27]	10 / 10 (100.00%)	10 / 10 (100.00%)
occurrences all number	10	10

Notes
[24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.
[27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: It is not clear to me what is requested of me. The message is not clear. I have entered the total number of patients who received at least 1 study vaccine in the "number of subjects exposed". However, this does not seem to be correct. PLease advise on which number must be entered.

More information

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Were there any global substantial amendments to the protocol? Yes

24 Apr 2018

- Adjustment of time interval between visits to comply with other care programs of the different patient groups - Adjustment of inclusion criterium for patients living with HIV: an undetectable viral load in the past 16 months instead of 12 months to allow for inclusion of more HIV patients who have a yearly assessment, but in practice this is often around 12 months (taking broad intervals)

21 Nov 2018

- Adjustment of number of patients living with HIV to be included from 140 originally to 100 patients - Add additional evaluation criterium, namely GMT ratio (Pre- and post-vaccination) in patients who are already seropositive for one or more HPV types. - Adjustment in the framework of the new European privacy laws

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/33373429

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Clinical trials

Clinical Trial Results:
An Open-label phase III study to investigate the safety, tolerability and immunogenicity of a nine-valent human papillomavirus (HPV) vaccine (Gardasil®9) in solid organ transplant recipients and HIV-infected patients

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines

Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: An Open-label phase III study to investigate the safety, tolerability and immunogenicity of a nine-valent human papillomavirus (HPV) vaccine (Gardasil®9) in solid organ transplant recipients and HIV-infected patients

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines

Primary: Seroconversion Following 3 Doses of 9-valent HPV Vaccines

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
An Open-label phase III study to investigate the safety, tolerability and immunogenicity of a nine-valent human papillomavirus (HPV) vaccine (Gardasil®9) in solid organ transplant recipients and HIV-infected patients