2004N-0355 - Scientific Considerations Related to Developing Biotechnology Products
FDA Comment Number : EC2
Submitter : Ms. J LeClair Date & Time: 09/23/2004 04:09:09
Organization : Ms. J LeClair
Health Professional
Category :
Issue Areas/Comments
Due to Space limits on this electronic comment form, this is a continuation of comment number 7995.
Cancer Prevention Vaccines #2 threw #10

2. Cancer Prevention Vaccine #2. Epstein Barr virus (Burkitt's lymphoma, nasopharyngeal cancers, some types of brain cancer and breast cancer)
Disease burden. In developed countries 25-50% of adolescents are seronegative to Epstein Barr Virus (EBV). In 25-70% of these seronegative subjects, EBV infection results in infectious mononucleosis. In limited geographical areas, EBV is associated with Burkitt's lymphoma and nasopharyngeal carcinoma. In immunocompromized individuals, including AIDS, EBV is associated with lymphoproliferative diseases and lymphomas. Recent evidence suggests a possible association with Hodgkin's lymphoma, T-cell lymphomas, and about 10% of gastric carcinomas.
Burkitt's lymphoma (BL) is a malignant form of tumor associated with EBV.
Vaccines. The principal target of EBV neutralizing antibodies is the major virus surface glycoprotein gp220/350. A range of cell-mediated responses to EBV infection has also been described and is likely to be important in controlling persistent infection. CTL specific for the latent EBV nuclear antigens EBNA-3A, -3B, and -3C are predominant in a large portion of seropositive adults and children. Several vaccine candidates based on the gp220/350 have been developed. The soluble recombinant subunit is safe in humans but needs strong adjuvants to elicit acceptable efficacy (co-development by MedImmune , GlaxoSmithKline (GSK) and Henogen, a GSK joint venture managing clinical trials up to Phase 3). Live recombinant vaccinia vectors have been used to express the gp220/350 and confer protection in primates and in EBV-negative Chinese infants. Clinical trials of an EBNA-3A peptide have been conducted in Australia (Jordan Report 2000 ).
Due to space limits on this electronic comment form Cancer Prevention Vaccine #3 is on the next comment form.