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Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors

This is not the most recent version

Appendices

Appendix 1. Characteristics of currently licensed prophylactic HPV vaccines

 

 

Monovalent vaccine

Bivalent vaccine

Quadrivalent vaccine

Manufacturer

Merck, Sharp & Dome (Merck & Co, Whitehouse Station, NJ, USA)

GlaxoSmithKline (GSK, Rixensart, Belgium)

Merck, Sharp & Dome (Merck & Co, Whitehouse Station, NJ, USA)

Antigens

HPV16 (40 μg)

L1 VLPs of HPV16 (20 μg) and HPV18 (20 μg)

L1 VLPs of HPV6 (20 μg), HPV11 (40 μg), HPV16 (40 μg) and HPV18 (20 mg)

Vaccination schedule

3 doses: at day 1, month 2 and month 6

3 doses: at day 1, month 1 and month 6

3 doses: at day 1, month 2 and month 6

Adjuvant

225 μg amorphous aluminium hydroxyl‐phosphate sulphate

ASO4: 500 μg Aluminium hydroxide, 50 μg 3‐deacylated monophosphoryl lipid A (MPL)

225 μg amorphous aluminium hydroxyl‐phosphate sulphate

Trade name

Not commercialised

Cervarix

Gardasil, Silgard

Produced by recombinant technology using

Saccharomyces cerevisae (baker’s yeast)

Baculovirus in Trichoplusia in insect cells

Saccharomyces cerevisae (baker’s yeast)

 Adapted from WHO 2009.

Appendix 2. MEDLINE Search strategy

The following search strategy will by used to retrieve references in MEDLINE (Ovid):

1) exp Papillomavirus Infections/
2) exp Papillomaviridae/
3) HPV*.mp.
4) human papillomavirus*.mp.
5) human papilloma virus*.mp.
6) or/1‐5
7) exp Papillomavirus Vaccines/
8) gardasil.mp.
9) cervarix.mp.
10) vaccin*.mp.
11) immuni*.mp.
12) or/7‐11
13) 6 and 12
14) randomized controlled trial.pt.
15) controlled clinical trial.pt.
16) randomized.ab.
17) placebo.ab.
18) drug therapy.fs.
19) randomly.ab.
20) trial.ab.
21) groups.ab.
22) or/14‐21
23) 13 and 22
24) (animals not (humans and animals)).sh.
25) 23 not 24
26) limit 25 to yr = "2002‐2011"

key:
mp = title, original title, abstract, name of substance word, subject heading word, unique identifier
pt = publication type
ab = abstract
sh = subject heading

Appendix 3. List of abbreviations

AGC: atypical glandular cells
AGUS: atypical glandular cells of undetermined significance
AIS: adenocarcinoma in situ
ASC: atypical squamous cells (comprises ASC‐US and ASC‐H)
ASC‐H: atypical squamous cells, HSIL cannot be ruled out
ASC‐R: atypical squamous cells favouring a benign reactive process squamous cells of undetermined significance
ASC‐US: atypical squamous cells of undetermined significance
ASCUS: atypical squamous cells of undetermined significance (comprises ASC‐R, ASC‐US and ASC‐H)
CDC: Centre for Disease Control
CGIN: cervical glandular intraepithelial neoplasia
CHMP: Committee for Medicinal Products for Human Use
CI: (95 %) confidence interval
CIN: cervical Intra‐epithelial neoplasia
CIS: carcinoma in situ
CISA: Clinical Immunization Safety Assessment
DNA: Desoxyribo‐nucleic acid
EC: endocervical curettage
ECDC: European Centre for Disease Control
EMEA: European Medicines Agency
EPAR: European Public Assessment Reports
FDA: Food and Drugs Agency
GSK: GlaxoSmithKline
HC: hybrid capture
HPV: human papillomavirus
HR: hazard ratio
hrHPV: high‐risk HPV type
HSIL: high‐grade squamous intraepithelial lesion
IARC: International Agency for Research on Cancer
lrHPV: low‐risk HPV type
LSIL: low‐grade squamous intraepithelial lesion
MCO: managed care organizations
MSD: Merck‐Sharp & Dome
NCBI: National Center for Biotechnology Information
ITT: intention‐to‐treat
PCR: polymerase chain reaction
PP: per‐protocol
RCT: randomised controlled trial
RD: risk difference
RR: risk ratio
TBS: The Bethesda System
UK: United Kingdom
USA: United States of America
VAERS: Vaccine Adverse Event Reporting System
VE: vaccine efficacy
VLP: virus‐like particles
VSD: Vaccine Safety Datalink
WHO: World Health Organization