Vaccine to prevent most cervical cancers shows long-term effectiveness

September 6, 2017
Credit: National Cancer Institute

A vaccine that can literally eradicate the majority of cervical cancer cases shows long-term effectiveness in a study published today in The Lancet. This study of 14,215 women in 18 countries extends and solidifies the initial phase 3 efficacy and safety trial of the nine-valent human papilloma virus vaccine, Gardasil 9, that was published in February 2015 in The New England Journal of Medicine.

These new results strengthen the promise that vaccination with Gardasil 9 can reduce 90 percent of cervical cancers.

"There is no question that the works," said primary author Warner Huh, M.D., professor and director of the University of Alabama at Birmingham Division of Gynecologic Oncology and a senior scientist at the UAB Comprehensive Cancer Center. "We're on the verge of a dramatic change that will positively affect all individuals, particularly women, in the United States. The challenge is to get the new vaccine into widespread use among young women."

The UAB Comprehensive Cancer Center and a coalition of Alabama health groups last year launched a formal call for action, urging Alabama parents and health care providers to get children—girls and boys—vaccinated against the sexually transmitted human papillomavirus, or HPV. The vaccine is unique in its ability to prevent certain cancers.

HPV infections cause global disease, including an estimated 266,000 deaths from cervical worldwide in 2012, according to the World Health Organization. Routine screening by Pap smears or tests for HPV infection has reduced death rates in developed countries compared to less developed regions of the globe. Still, an estimated 12,200 U.S. women a year are diagnosed with cervical cancer.

Gardasil 9, marketed by Merck & Co., was approved by the U.S. Food and Drug Administration in December 2014. The vaccine immunizes against nine genotypes of HPV known to cause cervical cancer, as well as vulvar, vaginal and anal cancers and genital warts caused by HPV. It is an advance over the four-valent HPV vaccine, Gardasil, which was approved by the FDA in 2006.

Huh helped develop and test Gardasil, which targets the two HPV genotypes known to cause about 70 percent of cervical cancer and two other genotypes that cause genital warts. Gardasil 9 targets those four genotypes and five additional ones as well. Both vaccines are prophylactic, meant to be given before females or males become exposed to possible HPV infection through intimate contact.

"Nationwide, 40 percent of girls and boys do not receive the HPV vaccine, and in the state of Alabama, almost half of girls and boys do not receive the HPV vaccine," Huh said. "With this new vaccine, there is a very legitimate opportunity to wipe out cancers that are caused by HPV, particularly cervical cancer in women.

"Seventy-five years ago, cervical cancer was a very common cause of mortality in the United States. Looking forward, with widespread vaccination, it is highly likely that will evolve into historical interest only, and screening, like Pap smears, might go away altogether. HPV vaccines are one of the most scrutinized vaccines ever, but multiple studies have demonstrated the vaccine to be safe and well-tolerated."

In the Lancet study, women were followed for efficacy at preventing disease for up to six years after the first vaccine shots, and they were followed for production of infection-halting antibodies against the nine genotypes of HPV for more than five years. The randomized double-blind efficacy, immunogenicity and safety study involved 105 sites in Austria, Denmark, Germany, Norway and Sweden; Brazil, Chile, Colombia and Peru; Canada, Mexico and the United States; and Hong Kong, Japan, New Zealand, South Korea, Taiwan and Thailand.

Half the women were vaccinated with the four-valent Gardasil and half with the nine-valent Gardasil 9. They were followed via gynecological exams for evidence of infections or disease, and their blood sera were tested for antibody levels against HPV.

Gardasil 9 showed 97.4 percent efficacy to prevent infections and disease caused by the five additional HPV genotypes not included in the four-valent Gardasil vaccine. Gardasil 9 vaccination produced similar antibody protection against the four HPV genotypes in Gardasil. The two vaccines also had similar safety profiles.

The nine-valent HPV vaccine has now been licensed in more than 60 countries for prevention of HPV-related anogenital cancers and precancers, and genital warts. Results of the Lancet study support the public health value of—and the need for—comprehensive vaccination programs.

Explore further: Screening, HPV vaccine can prevent cervical cancer: FDA

More information: Warner K Huh et al, Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial, The Lancet (2017). DOI: 10.1016/S0140-6736(17)31821-4

Related Stories

Screening, HPV vaccine can prevent cervical cancer: FDA

February 8, 2017
(HealthDay)—Women can reduce their risk of cervical cancer through vaccination and screening, the U.S. Food and Drug Administration says.

New HPV vaccine strengthens cancer protection

December 10, 2014
The drugmaker Merck & Co. Inc. has received approval for an updated version of its Gardasil vaccine that protects against an additional five strains of the virus that causes most cases of cervical cancer.

New HPV approved after international phase 2/3 trial

February 20, 2015
Approximately 12,000 women are diagnosed with cervical cancer each year in the United States and another 4,000 die annually from the disease. However, most cervical cancers are preventable through immunization against the ...

New HPV vaccine offers greater protection against cervical cancer than current vaccine

February 18, 2015
Scientists have developed a new HPV (human papilloma virus) vaccine which protects against nine types of the virus - seven of which cause most cases of cervical cancer. The new vaccine offers significantly greater protection ...

New study shows HPV vaccine is reducing rates of genital warts

March 29, 2017
The human papillomavirus (HPV) vaccine was introduced in Australia in 2007 and New Zealand in 2008 to prevent cervical cancer. It was free for women up to age 26 in Australia and to all women under 20 in New Zealand. This ...

Recommended for you

Lung cancer triggers pulmonary hypertension

November 17, 2017
Shortness of breath and respiratory distress often increase the suffering of advanced-stage lung cancer patients. These symptoms can be triggered by pulmonary hypertension, as scientists at the Max Planck Institute for Heart ...

Researchers discover an Achilles heel in a lethal leukemia

November 16, 2017
Researchers have discovered how a linkage between two proteins in acute myeloid leukemia enables cancer cells to resist chemotherapy and showed that disrupting the linkage could render the cells vulnerable to treatment. St. ...

Computer program finds new uses for old drugs

November 16, 2017
Researchers at the Case Comprehensive Cancer Center at Case Western Reserve University School of Medicine have developed a computer program to find new indications for old drugs. The computer program, called DrugPredict, ...

Pharmacoscopy improves therapy for relapsed blood cancer in a first clinical trial

November 16, 2017
Researchers at CeMM and the Medical University of Vienna presented a preliminary report in The Lancet Hematology on the clinical impact of an integrated ex vivo approach called pharmacoscopy. The procedures measure single-cell ...

Wider sampling of tumor tissues may guide drug choice, improve outcomes

November 15, 2017
A new study focused on describing genetic variations within a primary tumor, differences between the primary and a metastatic branch of that tumor, and additional diversity found in tumor DNA in the blood stream could help ...

A new strategy for prevention of liver cancer development

November 14, 2017
Primary liver cancer is now the second leading cause of cancer-related death worldwide, and its incidences and mortality are increasing rapidly in the United Stated. In late stages of the malignancy, there are no effective ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.