Gardasil (Merck & Co.), also known as Gardisil or Silgard, is a vaccine to prevent certain types of human papillomavirus (HPV), specifically HPV types 16, 18, 6, and 11. HPV types 16 and 18 currently cause about 70% of cervical, 26% of head and neck and many vulvar, vaginal, cancer cases. HPV types 6 and 11 cause about 90% of genital warts cases.
Gardasil can only prevent, not treat, HPV infections, so to be effective it must be given before HPV infection occurs. Some HPV strains are sexually transmitted. HPV-16 has a 60% per-couple transmission rate.
The U.S. Food and Drug Administration (FDA) recommends vaccination before adolescence and potential sexual activity.
The research that led to the development of the vaccine began in the 1980s by groups at the University of Rochester, Georgetown University, and the US National Cancer Institute (NCI). In 1991, Australian investigators at The University of Queensland found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. However, these VLPs assembled poorly and did not have the same structure as infectious HPV. In 1993, a laboratory at the US National Cancer Institute was able to generate HPV16 VLPs that were morphologically correct. These VLPs were the basis for the HPV16 component of the Gardasil vaccine. The history of the discovery of this vaccine is described by McNeil. Upon commercialization of the vaccine, controversy involving intellectual property arose between the various groups that played a role in developing the vaccine.
Merck & Co. conducted a Phase III study named Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE II). This clinical trial was a randomized double-blind study with one controlled placebo group and one vaccination group. Over 12,000 women aged 16–26 from thirteen countries participated in the study. Each woman was injected with either Gardasil or a placebo on Day 1, Month 2, and Month 6. In total, 6,082 women were given Gardasil and 6,075 received the placebo.
Merck has tested the vaccine in several hundred 11- and 12-year-old girls. On February 27, 2006, the independent Data and Safety Monitoring Board recommended the clinical trials be terminated on ethical grounds, so that young women on placebo could receive Gardasil.
Gardasil is made up of the following ingredients
- Proteins of HPV Types 6, 11, 16, and 18
- aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant)
- yeast protein
- sodium chloride
- polysorbate 80
- sodium borate
- water for injection.
Gardasil is given in three 0.5 milliliter injections over six months. The second injection is two months after the first, and the third injection is four months after the second shot was administered.
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