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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 07/17/2007
Related Pages
Cervical Cancer Home Page 1
NCI's gateway for information about cervical cancer.

HPV Vaccines for Cervical Cancer 2
A collection of material about HPV and vaccines designed to prevent infections from certain types of the virus that may lead to cervical cancer.
Second HPV Vaccine Shows Early Positive Results

Adapted from the NCI Cancer Bulletin, vol. 4/no. 21, July 10, 2007 (see the current issue 3).

Positive interim results for a candidate vaccine to prevent persistent infections by human papillomavirus (HPV) types 16 and 18 were published in the June 30, 2007, issue of The Lancet (see the journal abstract 4). The vaccine Cervarix® was 90 percent effective in preventing grade 2 or 3 cervical intraepithelial neoplasia (CIN2+) that contained DNA from either virus type.

The results come from a large international trial of 18,644 women aged 15-25 sponsored by the drug's manufacturer, GlaxoSmithKline Biologicals (see the protocol summary 5). The trial design called for analysis of early results after 23 cases of CIN2+ were detected. Two of these cases were among the 9,258 women receiving the vaccine, and 21 were among the 9,267 controls who received a hepatitis A vaccine. The mean follow-up time was 14.8 months.

In an editorial, Drs. Jessica A. Kahn of the University of Cincinnati and Robert D. Burk of the Albert Einstein College of Medicine in New York wrote, "These interim data are encouraging." But they noted that the paper does not provide information about the public health impact of vaccination "in real world settings" because the report does not provide estimates of the reduction in overall rates of CIN2+. They stress that vaccination of young adolescents is likely to have the greatest public health benefit, but that continued screening will still be required after vaccination.    

A separate phase III trial testing Cervarix, cosponsored by the National Cancer Institute with support from the National Institutes of Health's Office for Research on Women's Health and the Costa Rica Ministry of Health, is now underway in Costa Rica. This trial should provide additional information about the public health impact and efficacy of the vaccine.



Glossary Terms

cervical intraepithelial neoplasia (SER-vih-kul IN-truh-eh-pih-THEE-lee-ul NEE-oh-PLAY-zhuh)
Growth of abnormal cells on the surface of the cervix. Numbers from 1 to 3 may be used to describe how abnormal the cells are and how much of the cervical tissue is involved. Also called CIN.
HPV
A type of virus that can cause abnormal tissue growth (for example, warts) and other changes to cells. Infection for a long time with certain types of HPV may cause cervical cancer. HPV may also play a role in some other types of cancer. Also called human papillomavirus.
mean
A statistics term. The average value in a set of measurements. The mean is the sum of a set of numbers divided by how many numbers are in the set.
phase III trial
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
vaccine
A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. A vaccine can help the body recognize and destroy cancer cells or microorganisms.


Table of Links

1http://www.cancer.gov/cancertopics/types/cervical
2http://www.cancer.gov/cancertopics/hpv-vaccines
3http://www.cancer.gov/ncicancerbulletin
4http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSea
rch=17602732&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPane
l.Pubmed_RVDocSum
5http://clinicaltrials.gov/ct/show/NCT00122681?order=1