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Jämförelse av antigenicitet och biverkningsprofil mellan Gardasil och Cervarix
Linnaeus University, Faculty of Health and Life Sciences, Department of Chemistry and Biomedical Sciences.
2017 (Swedish)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [sv]

Syftet var att undersöka vilket av vaccinen mot Humant papillomvirus-HPV, Gardasil eller Cervarix som är att föredra, med avseende på biverkningsprofilen, det vill säga vilket av vaccinen som är mest skonsamt för kroppen. HPV-vaccinen skyddar mot HPV-typerna 16 och 18 som bland annat orsakar livmoderhalscancer. Viruset smittar via sexuell kontakt och infekterar främst celler i mukosa. Infektionsfrekvensen av HPV är likvärdig mellan män och kvinnor. Det finns högrisktyper av HPV (HPV16/18) som orsakar cancer och det finns lågrisktyper som orsakar genitala vårtor (HPV 6/11). Gardasil innehåller fyra HPV-typer (HPV6/11/16/18) och Cervarix innehåller två HPV-typer (HPV16/18). Mycket vanliga biverkningar (≥1/10) för båda vaccinen är huvudvärk, svullnad, rodnad, och smärta vid injektionsstället. Vanliga biverkningar (≥1/100 eller <1/10) är bland annat feber, illamående och klåda. Fyra artiklar valdes ut med pubmed via sökorden ”Gardasil”, ”Cervarix” och ”safety”. Studie 1 handlar om booster-dosering av bHPV/qHPV till flickor (12-13 år) som tidigare hade fått två doser av qHPV tillsammans med Twinrix (Hepatit A/B). I studie 2 jämfördes två doser bHPV med två respektive tre doser qHPV hos flickor 9-14 år, för att undersöka om vaccinen var likvärdiga eller om två doser bHPV var ett bättre val. Studie 3 och 4 var uppföljningsstudier till samma grundstudie med kvinnor från 18-45 år. Studie 3 pågick fram till månad 48 och studie 4 fram till månad 60. Studie 3 och 4 jämförde tre doser av bHPV med tre doser av qHPV avseende hur seropositiviteten förändrades över tiden. Cervarix fick lägre procentandelar i sin biverkningsprofil, vid jämförelse mot studie 1 och studie 2 (två doser av Cervarix som gavs i Studie 2). Slutsats var att båda vaccinen hade jämförbara biverkningsprofiler och var därför likvärdiga i det avseendet. Om seropositiviteten jämförs så har bHPV längre varaktighet än qHPV eller att qHPV är bättre val eftersom det även skyddar mot HPV 6 och 11.  

Abstract [en]

The purpose of this diploma work project was to determine if one of the HPV-vaccines, Cervarix-bHPV or Gardasil-qHPV, has lower safety adverse events- SAE.

There are more than 150 different types of human papillomavirus, which infect mucosal cells, mostly in the genital tract. The virus infects through sexual-contact, there are high-risk HPV-types such as HPV16/18, which are oncogenic and low-risk HPV-types such as HPV6/11, which cause genital warts. The goal for the world health organization-WHO is to get the HPV-vaccines to all women around the globe. Most common age for the vaccinées is 12-years. Headache, pain, erythema and swelling are very common adverse events for both of vaccines. Common adverse events are fever and nausea. In addition, Post Orthostatic Tachycardia Syndrome-POTS and Complex Regional Pain Syndrome-CRPS have been reported, mostly from Japan and Denmark. European medicines agency-EMA made a statement that the HPV-vaccines are not the cause of the POTS or CRPS (2015), because the profile of the symptoms from Japan and Denmark do not correlate with symptom profiles of POTS or CRPS. In Denmark’s case, EMA suggest that some of the cases resembles symptoms of chronic fatigue syndrome-CFS and not POTS.

This diploma work project was made with the help of Pubmed, with the words “Gardasil”, “Cervarix” and “safety”. Four articles were chosen from the search. 

The authors of the first article examined the effect of booster dose of bHPV or qHPV to girls age 12-13, who already had received two doses of qHPV. In the second article, two doses of bHPV were compared with two or three doses of qHPV in 9-14 year-old girls in order to determine if bHPV were equal or superior to two or three doses of qHPV. The third and fourth articles are follow-up studies of the second one, the third up to 48 months and the fourth up to 60 months. These articles were studying the sero-positivity in the vaccinated subjects over time.

When comparing study one and two, the bHPV safety profiles differences were seen in the safety adverse events in both local and general or systemic adverse events. There was a difference of adverse events between (article 2) three doses of qHPV to (article 1) booster dose of qHPV. Sero-positivity showed that bHPV induced high titres of HPV 16 and 18 antibodies while qHPV vaccine also induced high amounts of HPV 16 antibodies but low amounts of HPV 18 antibodies. About 20 % of the women in qHPV-groups lost sero-positivity by month 60. bHPV and qHPV vaccines were similar regarding adverse events. The vaccines had equal types of local and systemic or general adverse events. Sero-positivity was higher in subject vaccinated with bHPV compared to qHPV, with the highest decline in sero-positivity for anti-HPV 18.

The conclusions of this literature study is that the qHPV vaccine protects against low-risk and high-risk HPV-types, while the bHPV vaccine has longer duration.

Place, publisher, year, edition, pages
2017. , p. 38
Keywords [sv]
Ceravrix, Gardasil, HPV
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-62789OAI: oai:DiVA.org:lnu-62789DiVA, id: diva2:1092468
Subject / course
Pharmacy
Educational program
Bachelor of Science Programme in Pharmacy, 180 credits
Supervisors
Examiners
Available from: 2017-05-03 Created: 2017-05-03 Last updated: 2017-05-03Bibliographically approved

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