Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Abstract

Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and CD-ROM forms and are available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X.

Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2006 monograph topics are panitumumab, sitagliptin phosphate, fentanyl buccal tablet, arformoterol tartrate, and vorinostat. The DUE is fentanyl buccal.

Get full access to this article

View all access options for this article.

References

Gardasil [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2006.

Centers for Disease Control and Prevention. Sexually Transmitted Diseases: HPV Vaccine Questions and Answers. June 2006. Available at: http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine.htm. Accessed July 11, 2006.

CDC's Advisory Committee recommends human papillomavirus virus vaccination [press release]. Atlanta, GA: Centers for Disease Control and Prevention; June 29, 2006. Available at: http://www.cdc.gov/od/oc/media/pressre1/r060629.htm. Accessed July 6, 2006.

Centers for Disease Control and Prevention. Sexually Transmitted Diseases: Genital HPV infection – CDC Fact Sheet. May 2004. Available at: http://www.cdc.gov/std/hpv/stdfact-hpv.htm. Accessed July 11, 2006.

G.Y.

, Bierman

, Beardsley

, Chang

C.J.

, Burk

R.D.

Natural history of cervicovaginal papillomavirus infection in young women. N Engl J Med. 1998; 338: 423–428.

Villa

L.L.

, Ault

K.A.

, Giuliano

A.R.

. Immunologic responses following administration of a vaccine targeting human papillomavirus types 6, 11, 16, and 18. Vaccine. 2006; 24: 5571–5583.

Mao

, Koutsky

L.A.

, Ault

K.A.

. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol. 2006; 107: 18–27.

Poland

G.A.

, Jacobson

R.M.

, Koutsky

L.A.

. Immunogenicity and reactogenicity of a novel vaccine for human papillomavirus 16: a 2-year randomized controlled clinical trial. Mayo Clin Proc. 2005; 80: 601–610.

Brown

D.R.

, Fife

K.H.

, Wheeler

C.M.

. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine. Vaccine. 2004; 22: 2936–2942.

10.

Koutsky

L.A.

, Ault

K.A.

, Wheeler

C.M.

. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002; 347: 1645–1651.

11.

Emeny

R.T.

, Wheeler

C.M.

, Jansen

K.U.

. Priming of human papillomavirus type 11-specific humoral and cellular immune responses in college-aged women with a virus-like particle vaccine. J Virol. 2002; 76: 7832–7842.

12.

Ault

, Giuliano

A.R.

, Edwards

R.P.

. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine. Vaccine. 2004; 22: 3004–3007.

13.

Harper

D.M.

, Franco

E.L.

, Wheeler

. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomized controlled trial. Lancet. 2004; 364: 1757–1765.

14.

Fife

K.H.

, Wheeler

C.M.

, Koutsky

L.A.

. Dose-ranging studies of the safety and immunogenicity of human papillomavirus type 11 and type 16 virus-like particle candidate vaccines in young healthy women. Vaccine. 2004; 22: 2943–2952.

15.

Gardasil (human papillomavirus [types 6, 11, 16, 18] recombinant vaccine): Vaccines and Related Biological Products Advisory Committee (VRBPAC) briefing document. Whitehouse Station, NJ: Merck & Co., Inc.; April 19, 2006. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B1.pdf. Accessed July 11, 2006.

16.

Villa

L.L.

, Costa

R.L.

, Petta

C.A.

. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005; 6: 271–278.

17.

Skjeldestad

F.E.

Prophylactic quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine (Gardasil) reduces cervical intraepithelial neoplasia (CIN) 2/3 risk [abstract]. 43rd Annual Meeting of the Infectious Disease Society of America; October 6–9, 2005; San Francisco, CA. Abstract LB-8a.

18.

Paavonen

Efficacy of a quadrivalent HPV (types 6/11/16/18) L1 virus-like particle (VLP) vaccine against vaginal and vulvar pre-cancerous lesions: a combined analysis [abstract]. J Clin Oncol. 2006 ASCO Annual Meeting Proceedings Part I. 2006; 24(Suppl 18S): abstract 5011.

19.

VRBPAC Background Document: Gardasil HPV Quadrivalent Vaccine, May 18, 2006 VRBPAC Meeting. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf. Accessed July 11, 2006.

20.

Lehtinen

, Idanpaan-Heikkila

, Lunnas

. Population-based enrolment of adolescents in a long-term follow-up trial of human papillomavirus vaccine efficacy. Int J STD AIDS. 2006; 17: 237–246.

21.

Taira

A.V.

, Neukermans

C.P.

, Sanders

G.D.

Evaluating human papillomavirus vaccination programs. Emerg Infect Dis. 2004; 10: 1915–1923.

22.

Sanders

G.D.

, Taira

A.V.

Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis. 2003; 9: 37–48.

23.

Dasbach

E.J.

, Elbasha

E.H.

, Insinga

R.P.

Mathematical models for predicting the epidemiologic and economic impact of vaccination against human papillomavirus infection and disease. Epidemiol Rev. 2006; 28: 22–100.