2004N-0355 - Scientific Considerations Related to Developing Biotechnology Products
FDA Comment Number : EC6
Submitter : Ms. J LeClair Date & Time: 09/23/2004 04:09:12
Organization : Ms. J LeClair
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
6. Cancer Prevention Vaccine (continued from comment 7995)
6. Chlamydia trachomatis cancer prevention vaccine (Has been identified in 78% of women with cervical cancer, co-factor to hpv 16 in cervical cancer development)
Disease burden. Chlamydia trachomatis is a small bacterium that cannot grow outside a living cell. Chlamydia trachomatis is primarily a human pathogen and the causative agent of eye, genital and respiratory diseases. The whole genome of C. trachomatis strain D/UW-3/CX (serovar D) was sequenced in collaboration between the University of California, Berkeley (Chlamydia Genome Project ) and the Stanford DNA Sequencing and Technology Development Center (Stanford Chlamydia Group ). Chlamydia trachomatis is the most prevalent bacterial pathogen causing sexually transmitted disease (STD) in the western world. Chlamydia trachomatis is the most frequent cause of Pelvic Inflammatory Disease (PID) and its long term consequences include chronic pain, ectopic pregnancy and infertility. In both sexes, conjunctivitis (that does not progress to blindness) and joint inflammation may occur. In men, Chlamydia trachomatis is the commonest cause of non-gonococcal or (less correctly) non-specific urethritis. In both men and women, asymptomatic infection is not uncommon. The organism is transmitted from one partner to another during sexual intercourse. Contamination of the hands with genital discharge may lead to a conjunctival infection following contact with the eyes. Babies born to mothers with infection of their genital tract frequently present with chlamydial eye infection within a week of birth (chlamydial ophthalmia neonatorum), and may subsequently develop pneumonia. Worldwide, the most important disease caused by Chlamydia trachomatis is trachoma, one of the commonest infectious causes of blindness. In some parts of the developing world, over 90% of the population becomes infected. Chlamydia Trachomatis is the second cause of blindness in the world, after cataract, and thus the first cause of preventable blindness dispite long- standing control efforts. The disease starts as an inflammation, and evolves to trachomatous trichiasis (at least one eyelash rubbing on the eyeball, or evidence of recent removal of interned eyelashes) and blindness due to trachomatous corneal opacity.
Vaccines. Antex Biologics has developed a subunit vaccine candidate for Chlamydia trachomatis. Phase I studies in the US will begin in the fourth quarter of 2002. This will be the first time that a Chlamydia trachomatis vaccine has been in the clinic in 30 years. On 3. February 2003 Antex Biologics announced that it has filed an initial Investigational New Drug Application for its TRACVAX(tm) vaccine with the FDA. TRACVAX is a recombinant subunit vaccine designed to prevent and treat infections caused by Chlamydia trachomatis. This Phase I clinical trial will be an open label, randomized trial designed to assess the general safety and immunogenicity of the vaccine, along with efficient dosing regimens.