Aug 13, 2009
Guidelines for Administration of Human Papillomavirus (HPV) Vaccine (Gardasil®) to Multiple Sclerosis Patients - UPDATED
NOTE: A RECENT CASE REPORT1 DESCRIBED THE ONSET ACUTE DISSEMINATED ENCEPHALOMYELITIS FOLLOWING THE SECOND IMMUNIZATION WITH GARDISIL (WILDEMANN ET AL., 2009) AND SUTTON ET AL. (2009) REPORTED FIVE PATIENTS WHO PRESENTED WITH MULTIFOCAL OR ATYPICAL DEMYELINATION SYNDROMES WITHIN 21 DAYS OF THE SECOND OR THIRD IMMUNIZATION (THREE OF WHOM HAD PREVIOUSLY EXPERIENCED CLINICALLY ISOLATED EPISODES OF NEUROLOGICAL DYSFUNCTION). 2 PENDING FURTHER DATA, ADMINISTRATION OF GARDISIL SHOULD BE PRECEDED BY A THOROUGH DISCUSSION OF THE POSSIBLE BENEFITS AND RISKS.
Gardasil® (Merck) is available as a prophylactic vaccine, designed to prevent the following conditions in girls and women 9 to 26 years of age:
• HPV 6, 11, 16 and /or 18-related cervical cancer
• cervical dysplasias
• vulvar and vaginal dysplasias
• condyloma acuminata
Gardasil is a vaccine prepared from noninfectious purified virus-like particles of recombinant major capsid (L 1) protein of HPV types 6, 11, 16, and 18. The product information states that individuals with impaired immune responsiveness may have reduced antibody response to active immunization due to:
• immunosuppressive therapy
• genetic defect
• HIV infection
Immune response to vaccines may be reduced due to immunosuppressive therapy, including:
• irradiation
• antimetabolites
• alkylating agents
• cytotoxic drugs
• corticosteroids (used in greater than physiologic doses)
This vaccine has been tested exclusively in 9 to 26-year-old healthy females (it has not been tested in an MS population):
• Safety and efficacy information is available only for healthy girls/women of that age group.
• Studies of the vaccine are now being done in boys/men and women older than 26 years of age.
• FDA consideration for licensing the vaccine for other groups will take place when there are data to show that it is safe and effective for them.
It is important for girls and women to get HPV vaccine before they become sexually active.
Immunizations and Multiple Sclerosis*, a clinical practice guideline published by the Multiple Sclerosis Council for Clinical Practice Guidelines in 2001, presents conclusions based upon available research data. The expert panel used the recommendations of the Centers for Disease Control and Prevention (CDC) as a foundation for the development of its guideline. The consensus of the panel, based on available research data, was that:
• People with MS should not be denied access to health-preserving and potentially-life saving vaccines because of their MS.
• Vaccinations that do not contain live viruses can be given to MS patients unless they are currently experiencing an exacerbation.
The immune modulators approved by the FDA for use in MS are not believed to contraindicate vaccination with Gardasil:
• Glatiramer acetate (Copaxone® )
• Interferon beta1a (Avonex® and Rebif®)
• Interferon beta1b (Betaseron®)
Natalizumab (Tysabri®) also should not contraindicate vaccination with Gardasil. Mitoxantrone (Novantrone®), like other immunosuppressive agents, would be likely to interfere with effective immunization by Gardasil.
1Wildemann B, Jauius S, Hartmann M, Regula JU, Hametner C. (2009). Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology, 72, 2132-2133.
2Sutton I, Lahoria R, Tan IL, Clouston P, Barnett MH. (2009). CNS demyelination and quadrivalent HPV vaccination. Multiple Sclerosis, 15, 116-119.