ERVARIX(tm), GSK's Cervical Cancer Vaccine Candidate Induced A Higher Immune Response In 10-14 Year-Old Girls Versus 15-25 Year-Old Young Women

Main Category: Cancer / Oncology
Article Date: 19 Dec 2005 - 13:00 PDT

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Cervarix(tm), GSK's candidate cervical cancer vaccine, formulated with the proprietary adjuvant AS04, induced antibody levels against the two most common cancer-causing HPV types (HPV 16/18) at least two-fold higher in 10-14 year old adolescent girls, than in women 15-25 years old, a new study shows. The candidate vaccine for cervical cancer was also shown to induce antibodies in 100 per cent of volunteers in both age groups one month after completion of the course of vaccination. The vaccine in the present study was well tolerated and adverse event rates were similar in each age group. No vaccine-related serious adverse events were reported.

Recent positive findings have demonstrated that the AS04 adjuvant in the candidate vaccine induces a stronger, sustained immune response when compared to a formulation with aluminium salt alone in young adult women. In the study presented today, the higher antibody levels observed in the pre-teen/adolescent group - compared to that observed in women 15-25 years old - are important as the elevated levels demonstrated in this younger age range may result in longer duration of protection. It would be beneficial to vaccinate adolescents against infection with cancer-causing HPV types 16/18 well before the start of sexual activity with a vaccine with sustained efficacy. While GSK's goal is to provide a cervical cancer vaccine for women over a broad age range, today's study was designed specifically to compare the immunogenicity and safety of the candidate vaccine in the younger 10-14 year old group with the 15-25 year old group. The results were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in Washington DC, USA.

"Vaccination of pre-teen/adolescent girls against cancer-causing HPV before onset of sexual activity will be an important part of the overall strategy for cervical cancer prevention," said Anna-Barbara Moscicki, MD, Professor of Pediatrics, University of California, San Francisco. "Prevention of high-risk HPV 16 and HPV 18 infection is key to reducing cervical cancer, and a prophylactic vaccine against these types of HPV is necessary to prevent infection in the first place. The higher levels of antibody titers seen in the vaccinated preteens/teens than the vaccinated adults offers encouraging evidence that in this age group, a stronger immune response could translate into longer protection. Ongoing studies should further demonstrate these findings."

HPV is the leading cause of cervical cancer. Globally, approximately 70 per cent of all cervical cancer cases are associated with just these two cancer-causing types, HPV 16 and HPV 18. GlaxoSmithKline's cervical cancer vaccine candidate targeting HPV 16/18 is currently undergoing Phase III clinical trials involving more than 30,000 women worldwide.

About the study

This was a Phase III, randomized, double-blinded trial conducted in multiple centres in Denmark, Estonia, Finland, Greece, the Netherlands and the Russian Federation. All subjects received the HPV-16/18 AS04-containing vaccine as follows: 158 healthy pre-teen/adolescent girls [10-14 years] and 458 young women [15-25 years] received the candidate HPV-16/18 vaccine according to a 0, 1, 6 month schedule Anti-HPV-16/18 antibody titers were assessed at month 0 and 7 by ELISA (EU/ml) test (a common immunology test - Enzyme-Linked Immunosorbent Assay).

At month seven (7), 100 per cent seropositivity was achieved in both groups for HPV 16 and 18. Geometric mean antibody titers (GMTs) in the 10-14 year old group were 17273 (95% CI 15118-19734) for HPV 16 (n=143) and 6864 (95% CI 5976-7883) for HPV 18 (n=141); in the 15-25 year old group 7293 (95 %CI 6624-8030) for HPV 16 (n=359) and 3319 (95% CI 3023-3644) for HPV 18 (n=364). For both HPV 16 and 18, GMTs in 10-14 year old girls were at least two-fold higher.

About Cervical Cancer

Cervical cancer is a major global health problem, with nearly 500,000 new cases occurring each year worldwide. It is the second most common cancer - and the third leading cause of cancer deaths - in women worldwide. Each year an estimated 270,000 women die from the disease, and it is the leading cancer killer of women in the developing world. [1] HPV infection is the necessary cause of cervical cancer.[2] There are many oncogenic types of HPV; however, approximately 70 percent of all cervical cancer cases are associated with only two of the oncogenic types, HPV 16 and HPV 18. [3]

HPV infection is very common and it is estimated that up to 80 per cent of sexually active women will acquire a genital HPV infection by the age of 50. [4] The risk starts right from sexual debut [5] and often infection is with oncogenic types. [6] HPV infections are usually transient and generally cause no symptoms.4 Persistent infection with oncogenic types of HPV may lead to cervical cancer. [7]

Screening is important, but it does not detect all pre-cancerous lesions or cancer. [8] The risk of developing cervical cancer is approximately five times higher in women who are not regularly screened. [9] Where they exist, screening programmes can identify abnormal cells and pre-cancerous lesions. [10] In addition, there are personal and social costs associated with abnormal pap tests and cervical cancer - including emotional distress and anxiety. [11]

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

http://www.gsk.com

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