Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03525210
• Date of registration: 02/05/2018
• Prospective Registration: No
• Primary sponsor: Universitaire Ziekenhuizen Leuven
• Public title: Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients
• Scientific title: 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
• Date of first enrolment: April 4, 2018
• Target sample size: 271
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03525210
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium

Contacts

• Name: Corinne Vandermeulen, MD, PhD
• Affiliation: UZ Leuven

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Independent Ethics Committee (IEC)-approved written informed consent form (ICF) must
be obtained from the subject prior to any study-related procedures (including
discontinuation of prohibited medication, if applicable) by the subject is given as
required by local law.

2. 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

3. Subject is able to understand and adhere to the study procedures (e.g., is not
planning to relocate far from the investigational centre during the study period); is
able to read, understand, and complete the vaccination diary; is able to understand
the risks involved with the study; and voluntarily agrees to participate in the study
by giving written informed consent.

4. * Since the first day of their last menstrual period through Day 1, female subjects
have not had sex with males or has had sex with males and used effective contraception
with no failures (an example of a failure is a male condom that ruptures during sexual
intercourse). Effective contraception is defined as a marketed, approved contraceptive
product that the subject has used per the manufacturer's instructions with every act
of sexual intercourse. The subject understands and agrees that during the Day 1
through Month 7 period, she should not have sexual intercourse with males without
effective contraception. The use of the rhythm method alone, withdrawal alone, and
emergency contraception, are not acceptable methods per the protocol. Subjects who
have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral
tubal ligation are eligible without the use of contraceptives. Postmenopausal status
is defined as: (1) No menses for >1 year but <3 years and confirmed by follicle
stimulating hormone (FSH) levels elevated into the postmenopausal range, or (2) no
menses for at least 3 years.

5. * Subject has had no temperature =37.8°C within 24 hours prior to the first injection.

6. Patient considerations

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

- SOT 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).

7. Apart from having HIV or received a solid organ transplant, the subject is in stable
condition (i.e. no graft-versus-host disease or other immunological reactions) and is
judged to be in good physical health on the basis of medical history, physical
examination (if deemed necessary), and laboratory testing

8. Subject agrees to provide study personnel with a primary telephone number as well as
an alternate telephone number for follow-up purposes.

Exclusion Criteria:

1. Subject has a history of an abnormal Pap test or abnormal cervical biopsy results
(showing cervical intraepithelial neoplasia or worse) or cervical disease (i.e.,
surgical treatment for cervical lesions).

2. Subject has history of genital warts, Vulvar Intraepithelial Neoplasia or Vaginal
Intraepithelial Neoplasia.

3. Subject has a history of a positive test for HPV.

4. Subject has a history of known prior vaccination with an HPV vaccine, i.e., received a
marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has
received either active agent or placebo.

5. Subject is pregnant (as determined by serum or urine pregnancy test).

6. Subject is, at the time of signing ICF, a user of recreational or illicit drugs or has
had a recent history (within the last year) of drug or alcohol 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.

7. Subject has a history of severe allergic reaction, including known allergy to any
vaccine component, including aluminum, yeast, or BENZONASE® (nuclease, Nycomed [used
to remove residual nucleic acids from this and other vaccines]) (e.g., swelling of the
mouth and throat, difficulty breathing, hypotension or shock) that met the criteria
for serious adverse experiences defined in this protocol.

8. Patient's condition

1. Exclusion criterion only for HIV patients: Subject has had a splenectomy, or has
been diagnosed as having a congenital immunodeficiency, lymphoma, leukaemia,
systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid
arthritis, inflammatory bowel disease, or other autoimmune or immunosuppressive
condition, or has a history of any disease, which, in the investigator's opinion,
may confound the results of the study or pose an additional risk to the subject.

2. Exclusion criterion only for SOT patients: Subject has had a splenectomy, or has
been diagnosed as having a congenital or acquired immunodeficiency, HIV
infection, lymphoma, leukaemia, systemic lupus erythematosus, rheumatoid
arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other
autoimmune or immunosuppressive condition, or has a history of any disease,
which, in the investigator's opinion, may confound the results of the study or
pose an additional risk to the subject.

9. Patient's medication

1. Exclusion criterion only for HIV patients: 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 (tumour necrosis factor-a antagonists,
monoclonal antibody therapies (including rituximab [Rituxan]), intravenous gamma
globulin, antilymphocyte sera, or other therapy known to interfere with the
immune response. With regard to systemic corticosteroids, a subject will be
excluded if she 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 (=20mg/day of prednisone [or equivalent]
orally or parenterally) lasting at least 1 week in duration in the year prior to
enrolment. Subjects using inhaled, nasal, or topical corticosteroids are
considered eligible for the study

2. Exclusion criterion only for SOT pat


Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Organ Transplants

Hiv

Human Papilloma Virus

Intervention(s)

Biological: 9-valent HPV vaccine

Primary Outcome(s)

Seroconversion Following 3 Doses of 9-valent HPV Vaccines [Time Frame: 7 months (for each subject)]

Secondary Outcome(s)

Adverse Reactions Following 9-valent HPV Vaccination [Time Frame: 7 months (for each subject)]

Secondary ID(s)

503-IC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03525210