This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Reproductive neoplasms female malignant and unspecified
Synonym
Health condition
premaligne genitale laesies (cervicaal, vulvair en vaginaal) en genitale wratten (condylomata acuminata)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Immunogenicity
Secondary outcome
Tolerability and humoral immune response.
Background summary
V503 is a prophylactic 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and
58) L1 virus-like particle (VLP) vaccine1 that is composed of VLPs of the 4 HPV
types (Type 6, 11, 16, and 18) contained in GARDASIL®2, plus the VLPs of 5
additional oncogenic HPV types (Type 31, 33, 45, 52, and 58). V503 efficacy to
prevent HPV diseases caused by the 9 vaccine HPV types is currently being
assessed in young women, 16 to 26 years of age, under a different study
(Protocol V503-001).
A Phase 3 study of GARDASIL® in young men, 16 to 26 years of age (Protocol
V501-020) demonstrated that GARDASIL® is highly efficacious in preventing
genital warts caused by HPV types 6 and 11, anal cancer caused by HPV types 16
and 18, and Anal Intraepithelial Neoplasia (AIN) grades 1, 2, and 3 caused by
HPV types 6, 11, 16, and 18.
A study (Protocol V503-003) to evaluate the immunogenicity and tolerability of
V503 in young men, 16 to 26 years of age, in comparison to young women, 16 to
26 years of age, is ongoing.
The safety and immunogenicity of V503 in adolescent boys, 9 to 15 years of age
has been assessed in another study (Protocol V503-002). Safety data are
summarized in the V503 Investigator*s Brochure.
Study objective
This study is designed to evaluate the immunogenicity and tolerability of V503
in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men,
16 to 26 years of age. The safety and immunogenicity data will be used to
bridge GARDASIL® efficacy findings to V503 with respect to HPV types 6, 11, 16,
and 18. Specifically, GDS07C will provide immunobridging from young men
administered GARDASIL® to young men administered V503 via demonstration of
non-inferior antibody responses to HPV types 6, 11, 16, and 18, as well as
comparable safety profile in both vaccine groups.
Study design
This study will enrol approximately 500 healthy 16- to 26-year-old men, all of
whom have not yet received a prophylactic HPV vaccine. The study will provide a
comparison of immunogenicity of 9vHPVvaccine and GARDASIL® for HPV 6, HPV 11,
HPV 16, and HPV 18, in this population. Men who have sex with men (MSM) will
not be enrolled since V503 is being evaluated in MSM in another study, Protocol
V503-003. The number of subjects to be enrolled in the study was determined
based on the primary immunogenicity objective.
All subjects will be administered a standard 3-dose regimen (Day 1, Month 2,
Month 6) of 9vHPVvaccine or GARDASIL®. Serum samples will be collected at Day 1
and Month 7 for anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody assays.
The primary time point for comparison of immune responses will be Month 7, i.e.
approximately 4 weeks following the third vaccination. The safety/tolerability
profile of the vaccine will be evaluated in all subjects in the study. Safety
information will be collected Day 1 through 1 month following the third
vaccination or for a total of approximately 7 months for each subject.
Intervention
Subjects will receive 9vHPVvaccine (Group 1) or GARDASIL® (Group 2). Study
vaccine will be administered as a 0.5-mL intramuscular injection at Day 1,
Month 2 and Month 6.
Study burden and risks
Possible Discomforts and Risks
Like all vaccines and medicines, GARDASIL® or the 9vHPV vaccine can cause side
effects. The following side effects can be seen after the use of GARDASIL®:
- Very commonly (more than 1 in 10 subjects), side effects found at the
injection site include: pain, swelling and redness. Headache was also reported.
-Commonly (more than 1 in 100 subjects), side effects found at the injection
site include: bruising, itching, pain in extremity. Fever and nausea have also
been reported.
- Rarely (less than 1 in 1000 subjects): hives (urticaria).
- Very rarely (less than 1 in 10,000 subjects), difficulty breathing
(bronchospasm) has been reported.
The following additional adverse events have been reported by people receiving
marketed GARDASIL®. These adverse events were voluntarily reported from a group
of people of unknown size. It is not possible to estimate the frequency of
these adverse events or the relationship of these adverse events to the vaccine.
-Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Although fainting episodes are uncommon, patients should be observed for 15
minutes after they receive HPV vaccine.
- As with other vaccines, side effects that have been reported during general
use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome
(muscle weakness, abnormal sensations, tingling in the arms, legs and upper
body), dizziness, vomiting, joint pain, aching muscles, unusual tiredness or
weakness, chills, generally feeling unwell, bleeding or bruising more easily
than normal, and skin infection at the injection site.
In the previous clinical trials with the 9vHPV vaccine, involving more than
15,000 subjects, the tolerability of this new HPV vaccine appears to be similar
to that of GARDASIL®. Overall, 7 subjects reported serious adverse events
considered by the Study Doctor to be related to the 9vHPV vaccine or to either
the 9vHPV vaccine or GARDASIL® as, for one study, it is not yet known which
subjects received GARDASIL® and which subjects received the 9vHPV vaccine.
- severe headache that started the day after receiving the second dose of the
9vHPV vaccine or GARDASIL® (1 subject) and another case that started the day of
the third dose of the 9vHPV vaccine (1 subject)
-severe sensory disturbance that started more than 2 weeks after receiving the
third dose of the 9vHPV vaccine or GARDASIL® (1 subject)
- severe fever that started the day after receiving the third dose of the 9vHPV
vaccine or GARDASIL® (1 subject)
- moderate asthmatic crisis that started the day after receiving the first dose
of the 9vHPV vaccine (1 subject)
- severe allergic reaction that started the day of the first dose of the 9vHPV
vaccine or GARDASIL® (1 subject)
- severe tonsillitis that started the day after receiving the first dose of the
9vHPV vaccine (1 subject).
As in any research study, the use of the study vaccines may be associated with
certain unforeseen risks. In addition, taking blood samples may be associated
with some inconveniences, such as slight pain and bruises from needle punctures.
Expected Benefits & Alternative Treatments
This study may allow the subject to be protected against diseases caused by HPV.
The subject may or may not benefit from taking part in this study. The results
from this study may help to develop this new HPV vaccine for other adolescents
or men.
avenue Jean Jaurès, CS 50712 162
Lyon Cedex 07 69367
FR
avenue Jean Jaurès, CS 50712 162
Lyon Cedex 07 69367
FR
Listed location countries
Age
Inclusion criteria
To be randomized and receive the first study vaccination, subjects must meet all inclusion criteria.
1. Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
2. Subject is a man who has had no more than 5 lifetime female sexual partners.
3. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
4. Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.
Exclusion criteria
To be randomized and receive the first study vaccination, subjects must not meet any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
1. Subject who has had sex with a male partner.
2. Subject has a history of HPV-related external genital lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma acuminata, anal intraepithelial neoplasia, or anal cancer).
3. Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE® (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event as defined in Section 3.4.
4. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
5. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
6. Subject is concurrently enrolled in clinical studies of investigational medicinal products.
7. *Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
8. Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
9. Subject has had a splenectomy.
10. Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab [MABTHERA®]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrolment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrolment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
11. Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
12. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
13. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
14. *Subject has had a fever (defined as an oral temperature of >=37.8°C) within the 24-hour period prior to the Day 1 vaccination.
15. Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
16. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
17. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
18. Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-003399-10-NL |
| CCMO | NL46721.000.13 |