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Cervarix

Manufactured by GlaxoSmithKline
Sourced in Belgium, United Kingdom

Cervarix is a laboratory equipment product manufactured by GlaxoSmithKline. It is designed for use in medical research and clinical settings. The core function of Cervarix is to enable testing and analysis related to human papillomavirus (HPV).

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22 protocols using cervarix

1

Long-term Cervical Cancer Vaccine Efficacy

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Costa Rica Vaccine Trial (CVT) evaluated the efficacy of the bivalent HPV16/18 vaccine (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium). CVT enrolled 7466 women aged 18–25 years during 2004–2005. Participants were randomised to three doses of Cervarix or the control hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Participants were followed-up annually for 4 years (more frequently, if clinically indicated). Cervical samples from sexually experienced women were collected for cytology and HPV-DNA testing at study visits.10 (link) At year 4 (2009–2010), the control group received HPV vaccination and was exited from the study.11 (link)
CVT transitioned into a long-term follow-up (LTFU). The HPV vaccine arm returned for additional study visits and a new unvaccinated control group (UCG) was recruited for comparison.11 (link) The UCG consisted of 2836 women from the same birth cohort and geographical region as the original controls. UCG was recruited concurrent with CVT participants year 4 visits. UCG women underwent intensive screening to identify/treat prevalent disease at enrolment. During the LTFU, the HPV and UCG groups returned for visits at years 7, 9 and 11, with additional visits if clinically indicated. Cervical samples from sexually experienced women were collected for cytology and HPV DNA testing at study visits.11 (link)
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2

Sublingual Delivery of AcHERV-triHPV Vaccine

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Mice were immunized with AcHERV-triHPV vaccines via the SL or IM route as depicted in Fig. 1. All mice received three immunizing doses at 2-week intervals by the same route. For SL immunization, mice were anesthetized with 40 mg/kg of Zoletil 50 (Virbac Laboratories) and 5 mg/kg of Rompun (Bayer Korea). Mice received different doses of sublingually delivered AcHERV-triHPV using a previously described procedure [13 (link)]. To prevent swallowing during SL immunization, the total volume of the inoculum was limited to 15 μl/mouse. For IM immunization, mice were intramuscularly injected in the hind legs with 1×109 copies of AcHERV-triHPV. For comparison, mice were immunized three times with Cervarix (GlaxoSmithKline, Middlesex, UK) at 1/20th of a human dose.
Serum and vaginal samples were collected 2, 4, and 6 weeks after the first immunization (day 0) via the SL or IM route (Fig. 1). Serum samples were obtained by centrifugation of whole blood collected from the right external jugular vein. Vaginal secretion samples were collected by rinsing the vaginal cavity five times with 30 μl of PBS. Vaginal secretion samples were then microcentrifuged at 13,000 rpm for 10 minutes, and the supernatants were collected and stored at -80°C until analyzed.
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3

HPV Vaccination in Danish Girls

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The Danish childhood vaccination programme is voluntary and free of charge. HPV vaccination with a quadrivalent vaccine (Gardasil®, MSD) was included in the Danish schedule for 12-year-old girls on 1 January 2009, with catch-up vaccination of 13–15 year old girls starting October 2008. The bivalent vaccine (Cervarix®, GSK) replaced the quadrivalent vaccine between 1 February 2016 and 31 October 2017. Since 1 November 2017, the nonavalent vaccine (Gardasil9®, MSD) has been used. We obtained information on HPV vaccinations from the Danish Vaccination Registry, which contains individual-level longitudinal information on all vaccinations in the Danish childhood vaccination programme.9
We obtained information on birth order, the mother’s age at the time of birth and the mother’s civil status, from the Danish Civil Registration System for each girl in the study cohort.8 (link)
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4

CERVARIX® Bivalent HPV Vaccine Protocol

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CERVARIX® is a bivalent HPV vaccine manufactured by GlaxoSmithKline plc. and presented as a suspension containing purified viral L1 protein for HPV types 16 and 18 and administered by intramuscular injection. It is produced using a baculovirus expression system. Each 0.5 mL dose of the bivalent vaccine contains 20 μg of HPV16 L1 protein and 20 μg of HPV18 L1 protein formulated with AS04 (containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A.
This vaccine is indicated for use in females and males from the age of 9 years for the prevention of premalignant anogenital lesions affecting the cervix, vulva, vagina and anus, and cervical and anal cancers causally related to specific HPV types [10 , 11 ]. Randomized clinical trials in Thailand have shown the vaccine is safe and immunogenic [12 (link), 13 (link)]. No serious adverse reactions have been recorded since the nationwide implementation of the 2D-regimen in Grade 5 (MOPH/DDC Epidemiology Department, Thailand).
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5

Immune Response to Vaccines in Mice

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The influenza vaccine (20 or 50 μL, influenza HA vaccine “KMB”; KM Biologics Co. Ltd., Kumamoto-city, Kumamoto, Japan), HBV vaccine (Bimmugen; KM Biologics Co. Ltd., Kumamoto-city, Kumamoto, Japan), CERVARIX (GlaxoSmithKline plc, Borough of Hounslow, London, UK), GARDASIL (MSD K.K. Chiyoda, Tokyo, Japan), or phosphate-buffered saline (PBS) as immunogen was injected intramuscularly into the quadriceps femoris muscle of 10-week-old 129P2(B6)-Nfκb1 wild-type, heterozygote, and homozygote mice, and F15 NOD Nfκb1 wild-type, heterozygote, homozygote mice, as well as NOD/ShiLtj mice, for immunological studies, including cardiac studies and allergy assay. Mice were given the second doses of influenza HA vaccine, Bimmugen, CERVARIX, GARDASIL, or PBS, 30 days following the first shot of the influenza HA vaccine, Bimmugen, CERVARIX, GARDASIL, or PBS.
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6

Parental Awareness of HPV Vaccines

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As part of the SC component, parents of all children aged 8 to 17 years were asked a series of questions about HPV vaccines. Parental awareness of HPV vaccines was defined as answering affirmatively (vs. negatively) to the following question: “Two vaccines, or shots, to prevent the HPV infection are available in the United States. Both vaccines prevent cervical cancer and one also prevents genital warts. The two HPV vaccines are sometimes called CERVARIX® [GlaxoSmithKline, Middlesex, UK] or GARDASIL® [Merck & Co., Inc., Whitehouse Station, NJ]. Before this survey, have you ever heard of HPV vaccines or shots?”
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7

HPV Vaccine Landscape and Protection

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Primary prevention of two oncogenic types of HPV has been possible since 2006, when the American Food and Drug Administration (FDA) approved the first HPV vaccines. Currently there are three different vaccines available worldwide: the bivalent vaccine (Cervarix, GlaxoSmithKline) protects against HPV types 16 and 18, which causes around 70% of cervical cancer worldwide (4). The quadrivalent vaccine (Gardasil4, Merck & Co.) protects against the same high-risk types, as well as types 6 and 11, which are associated with genital warts. The nonavalent Gardasil9 has been available since 2014 and protects against the same four types as Gardasil4, as well as against the 5 additional oncogenic types 31, 33, 45, 52 and 58. These seven HPV types cause around 90% of cervical cancer worldwide (4).
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8

Bivalent HPV Vaccine Immunogenicity

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Cervarix® (GlaxoSmith-Kline, Brentford, England, a bivalent human papillomavirus vaccine (types 16 and 18), is a recombinant protein virus-like particle. It was administered by intramuscular injection 0.5 mL at 0, 4 and 24 weeks. The primary immunogenicity endpoint was determined three weeks after the third vaccination dose.
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9

HPV Vaccination Uptake and Acceptance

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During the conduct of this study, HPV vaccination was offered to adolescents at the two clinics. Two products were used: Cervarix, that protects against HPV 16 and 18 (GlaxoSmithKline Biologicals, Rixensart, Belgium), and Gardasil, that protects against HPV 6, 11, 16 and 18 (Merck & Co, Inc, Whitehouse Station, NJ, USA). The information on uptake of vaccination and number of vaccines received was collected. All adolescents who elected to receive the vaccine had it after completing the baseline visit assessment.
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10

HPV Vaccination Uptake and Acceptance

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During the conduct of this study, HPV vaccination was offered to adolescents at the two clinics. Two products were used: Cervarix, that protects against HPV 16 and 18 (GlaxoSmithKline Biologicals, Rixensart, Belgium), and Gardasil, that protects against HPV 6, 11, 16 and 18 (Merck & Co, Inc, Whitehouse Station, NJ, USA). The information on uptake of vaccination and number of vaccines received was collected. All adolescents who elected to receive the vaccine had it after completing the baseline visit assessment.
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