Clinical Trial Results:
Effect of vaccination in patients with recurrent respiratory papillomatosis– can we improve the quality of life of these patients?
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Summary
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EudraCT number |
2011-002667-14 |
Trial protocol |
CZ |
Global end of trial date |
31 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2022
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First version publication date |
15 Dec 2022
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Other versions |
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Summary report(s) |
Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
UHKT-RLP/2011
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01375868 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Institute of Hematology and Blood Transfusion
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Sponsor organisation address |
U Nemocnice 1, Prague, Czechia, 128 20
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Public contact |
Head of the Laboratory, Institute of Hematology and Blood Transfusion, 00420 325873922, tachezr@natur.cuni.cz
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Scientific contact |
Head of the Laboratory, Institute of Hematology and Blood Transfusion, 00420 325873922, tachezr@natur.cuni.cz
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Vaccines against human papillomaviruses are now commercially available. One of the commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. After vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. The preliminary data are now available showing the presence of HPV-specific antibodies in the oral cavity in women after vaccination. The level of antibodies has been dependent on time since vaccination.
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Protection of trial subjects |
All subjects were enroled upon signature of the informed consent. The cinical trial was insured. All side effects were reported to the regulatory organ.
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Background therapy |
No | ||
Evidence for comparator |
No | ||
Actual start date of recruitment |
12 Aug 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy, Scientific research | ||
Long term follow-up duration |
5 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Czechia: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
46
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
ENROLMENT OF THE FIRST PATIENT OCTOBER 25, 2011 CZECHIA, PRAGUE | ||||||||||
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Pre-assignment
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Screening details |
50 subjects screened | ||||||||||
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Pre-assignment period milestones
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Number of subjects started |
50 | ||||||||||
Number of subjects completed |
50 | ||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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didn´t RRP patients | ||||||||||
Arm description |
Patients with RRP. All of the enroled subjects were vaccinated. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
HPV tetravalent vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
The first dose of the vaccine within 1 month after enrollment, the second dose followed within 2 months, and the third one within 6 months after the first dose.
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
50 adults with active RRP were enrolled and followed up. For the final outcome, follow-up data for 42 patients were available. Eight patients who did not fulfill the protocol were excluded. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
The number of recurrences
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
We have evaluated if the HPV vaccination lowers the number of recurrences requiring surgical intervention in patients with new and recurrent RRP.
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Subject analysis set title |
Level of HPV-specific antibodies
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
We compared the prevaccination and postvaccination positivity for HPV-specific antibodies.
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End points reporting groups
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Reporting group title |
didn´t RRP patients
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Reporting group description |
Patients with RRP. All of the enroled subjects were vaccinated. | ||
Subject analysis set title |
The number of recurrences
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
We have evaluated if the HPV vaccination lowers the number of recurrences requiring surgical intervention in patients with new and recurrent RRP.
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Subject analysis set title |
Level of HPV-specific antibodies
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
We compared the prevaccination and postvaccination positivity for HPV-specific antibodies.
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End point title |
Number of recurrences | |||||||||
End point description |
This study compared the prevaccination and postvaccination positivity for HPV-specific antibodies. The main outcome was the difference in the frequency of RRP recurrences in the prevaccination and postvaccination period.
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End point type |
Primary
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End point timeframe |
The number of reccurences in the post-enrolment (postvaccination) period
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Statistical analysis title |
The number of recurrences | |||||||||
Statistical analysis description |
The prevaccination and postvaccination frequency of RRP recurrences were compared by the Wilcoxon signed-rank test. A 1-sided alternative of lower frequency
after vaccination was considered.
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Comparison groups |
didn´t RRP patients v The number of recurrences
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Number of subjects included in analysis |
92
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Median difference (final values) | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
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Adverse events information
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Timeframe for reporting adverse events |
The reporting starts immediately after the application of the first dose of the vaccine and continuous for up to 4 months after application of the third dose.
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Assessment type |
Non-systematic | ||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
RRP group
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Reporting group description |
All enroled patients. All received at least one dose of the vaccine. | ||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The absence of a placebo group due to a very variable course of the disease we determined that comparison of the disease outcome before and after the vaccination for the same participant would be more informative. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/35653138 |
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