Articles from FDA for the Vaccines and Related Biological Products
Advisory Committee Meeting

**Topic: HPV Vaccines**

**Dates: November 28-29, 2001**

**Basic Virology:**

Howley PM, Lowy DR. Papillomaviruses and their replication. Chapter 65
In: [Fields Virology]{.underline}. 4^th^ Edition. Eds: Knipe DM, Howley
PM, Griffin DE, Lamb RA, Martin MA, Roizman B, Straus SE. Lippincott
Williams & Wilkins. 2001.

Lowy DR, Howley PM. Papillomaviruses. Chapter 66 In: [Fields
Virology]{.underline}. 4^th^ Edition. Eds: Knipe DM, Howley PM, Griffin
DE, Lamb RA, Martin MA, Roizman B, Straus SE. Lippincott Williams &
Wilkins. 2001.

Stubenrauch F, Laimins LA. Human papillomavirus life cycle: active and
latent phases. [Semin Cancer Biol]{.underline} 1999;9:379-86.

**Natural history of CIN (Cervical Intraepithelial Neoplasia) (with or
w/o HPV information):**

Woodman CB, Collins S, Winter H, Bailey A, Ellis J, Prior P, Yates M,
Rollason TP, Young LS. Natural history of cervical human papillomavirus
infection in young women: a longitudinal cohort study.
[Lancet]{.underline} 2001;357:1831--36.

Koutsky LA, Holmes KK, Critchlow CW, Stevens CE, Paavonen J, Beckmann
AM, DeRouen TA, Galloway DA, Vernon D, Kiviat NB. A cohort study of the
risk of cervical intraepithelial neoplasia grade 2 or 3 in relation to
papillomavirus infection. [N Engl J Med]{.underline} 1992;327:1272-8.

Melnikow J, Nuovo J, Willan AR, Chan BK, Howell LP. Natural history of
cervical squamous intraepithelial lesions: a meta-analysis. [Obstet
Gynecol]{.underline} 1998;92:727-735.

Östör AG. Natural history of cervical intraepithelial neoplasia: a
critical review. [Int J Gynecol Pathol]{.underline} 1993;12:186--192.

**Virology and Cancer or Carcinoma *in situ*:**

Ylitalo N, Sorensen P, Josefsson AM, Magnusson PK, Andersen PK, Ponten
J, Adami HO, Gyllensten UB, Melbye M. Consistent high viral load of
human papilloma virus 16 and risk of cervical carcinoma *in situ*: A
nested case-control study. [Lancet]{.underline} 2000;355:2194-8.

Josefsson AM, Magnusson PK, Ylitalo N, Sorensen P, Qwarforth-Tubbin P,
Andersen PK, Melbye M, Adami HO, Gyllensten UB. Viral load of human
papillomavirus 16 as a determinant for development of cervical carcinoma
*in situ*: A nested case-control study. [Lancet]{.underline} 355:2189,
2000.

Ylitalo N, Josefsson A, Melbye M, Sorensen P, Frisch M, Andersen PK,
Sparen P, Gustafsson M, Magnusson P, Ponten J, Gyllensten U, Adami HO. A
prospective study showing long-term infection with human papillomavirus
16 before the development of cervical carcinoma *in situ*. [Cancer
Res]{.underline} 2000;60:6027-32.

Lehtinen M, Luukkaala T, Wallin KL, Paavonen J, Thoresen S, Dillner J,
Hakama M. Human papillomavirus infection, risk for subsequent
development of cervical neoplasia and associated population attributable
fraction. [J Clin Virol]{.underline} 2001;22:117-24.

**General and Therapy:**

Bristow RE, Montz FJ. Workup of the Abnormal Pap Test. [Clinical
Cornerstone]{.underline} 3:12-24, 2000.

Janicek, MF, Averette HE. Cervical Cancer: Prevention, Diagnosis, and
Therapeutics. [CA Cancer J Clin]{.underline} 2001;51:92-114.

Wharton JT and Tortolero-Luna G. Neoplasms of the cervix. Chapter 112
*in*: [Holland-Frei Cancer Medicine]{.underline} 5th Edition. Editors:
R.C. Bast, Jr., D. W. Kufe, R. E. Pollock, R. R. Weichselbaum, J. F.
Holland, E. Frei, III May, 2000 B.C. Decker, Inc.