Cervarix, a cervical cancer vaccine, induced antibody levels against the two most common cancer-causing human papillomavirus ( HPV ) types ( HPV 16/18 ) at least two-fold higher in 10-14 year old adolescent girls, than in women 15-25 years old.

Cervarix 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 AS04-containing vaccine was well tolerated and adverse event rates were similar in each age group. No vaccine-related serious adverse events were reported.

The results were presented at the InterscienceConference on Antimicrobial Agents and Chemotherapy ( ICAAC ), in Washington DC.

The study 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 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 .

At month seven , 100 per cent seropositivity was achieved in both groups for HPV 16 and 18.
Geometric mean antibody titers in the 10-14 year old group were 17273 for HPV 16 ( n=143 ) and 6864 for HPV 18 ( n=141 ); in the 15-25 year old group 7293 for HPV 16 ( n=359 ) and 3319 for HPV 18 ( n=364 ).

For both HPV 16 and 18, geometric mean antibody titers in 10-14 year old girls were at least two-fold higher.

Cervical cancer 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.
HPV infection is the necessary cause of cervical cancer.
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.

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.
The risk starts right from sexual debut and often infection is with oncogenic types.
HPV infections are usually transient and generally cause no symptoms.
Persistent infection with oncogenic types of HPV may lead to cervical cancer.

" 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, at the 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."

Source: GlaxoSmithKline, 2005


XagenaMedicine2005