EE385 Cost Effectiveness of Gender-Neutral Vaccination With Gardasil 9 Against HPV in Greece

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

Human papillomavirus is the most common sexually transmitted infection, and skin-to-skin genital contact is sufficient for virus transmission. Cervical cancer is the second-most common cancer in women living in less developed regions, with an estimated 445,000 new cases in 2012 and 230,000 deaths every year. Until now, more than 200 types of HPV have been identified, and about 15 types (HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -68, -82) have been shown to cause cervical cancer because they are able to transform infected cells into malignant tumor cells. The bivalent vaccine containing the serotypes 16 and 18 and the quadrivalent vaccine containing the serotypes 16, 18, 6 and 11, have been used in Italy for many years. The European Medicines Agency authorized marketing of the Gardasil 9 vaccine in the European Union on June 2015. Today, Public Health targets the immunization of adolescents of both genders based on new and important scientific evidence for maximum protection from all HPV related pathologies directly preventable with vaccination.

Persistent human papillomavirus (HPV) infections have been identified as the main causes of cervical cancer. HPV vaccination has become the preferred option for the prevention of cervical cancer and pre-cancerous lesions. The effectiveness of vaccination could be indirectly reflected in the level of anti-HPV antibody. Therefore, immunogenicity analysis plays an important role in the clinical evaluation of HPV vaccines. Up to now, three HPV vaccines including Cervarix®, Gardasil® and Gardasil® 9 have been licensed in many countries, but a standard assay for assessing the immunogenicity of HPV vaccines has not been established. Currently, pseudovirion-based neutralization assay (PBNA), ELISA and competitive luminex immunoassay(cLIA) are the three major assays widely used in clinical trials of HPV vaccines. This study reviewed the traits of the three assays, the immunogenicity and durability of the three HPV vaccines, as well as the immune responses induced in different populations. Key words: Human papillomavirus; Vaccine; Immunogenicity; Cervical cancer

Benefits of Gardasil outweigh the risk of POTS

Gardasil nine: Is the number enough??

In a paradigm shift in cancer prevention, two Human Papilloma (HPV) vaccines have been developed for the prevention of cervical cancer: Gardasil and Cervarix. This article reports on the findings of a study conducted in 2009 with the first generation of young Australian women to take part in the mass HPV vaccination programme. Thirty-one participants from six participative workshops describe the crucial role of trust in government and health institutions in facilitating compliance with mass HPV vaccination, as well as identifying points of vulnerability in that trust. In particular they discuss lack of knowledge, informed consent and the ‘misleading’ marketing of Gardasil as areas for concern, and describe their perceptions of programme implementation and their reasons for vaccinating or not vaccinating. Whilst uptake of Gardasil in Australia has been relatively successful, it is still below expectations and the optimal level required to achieve herd immunity. The research findings are relevant to the current debate surrounding policy and mass vaccination against HPV.

Men get shot at Gardasil

Although the human papillomavirus (HPV) vaccine (Gardasil or Cervarix) now is recommended for preteens of both sexes, we still understand relatively

Gardasil to replace Cervarix in the UK from September 2012

For both bivalent (Cervarix) and quadrivalent (Gardasil) human papillomavirus (HPV) vaccines, three-dose regimens impede ease of administration and raise cost. Investigators for an ongoing study of bivalent (HPV-16/18) vaccination in Costa Rican women (vaccine supplied by the manufacturer) evaluated whether one or two immunizations provide adequate protection …

Gardasil deemed "safe and effective" by Australian TGA

Achieving optimal vaccination levels in adolescents will likely be enhanced if several vaccines can be administered simultaneously. In a multicenter, open-label, randomized study funded by the manufacturer of the human papillomavirus (HPV) vaccine Gardasil, researchers examined the safety and immunogenicity of concomitant administration of Gardasil with meningococcal (Menactra), and Tdap (tetanus, diphtheria, pertussis; Adacel) vaccines in 394 boys and 648 girls aged 10–17 …

An 18-year-old woman suddenly died 6 months after receiving her third vaccination with Gardasil

Objective To study the relationship of HPV pseudo-neutralizing titers detected by two different reporter genes: Zoanthus sp. green fluorescent protein (ZsGreen) and secreted alkaline phosphatase (SEAP) , and the relationship between HPV the pseudovirus-neutralizing antibody titer and the antibody titer determined by ELISA method. Methods The plasmids with expression cassettes of the HPV capsid protein L1 and L2 genes after codon optimization and the plasmid with reporter gene (ZsGreen or SEAP) were co-transfected into 293FT cells. The cell lysate supernatants were collected after 48 h culture, then the pseudovirus was purified through POROS column chromatography from the supernatants. After the titer of pseudovirus bulk were measured, HPV-16 and HPV-18 pseudovirus-neutralization assays were carried out for determining the titer of sera collected from immunized mice with HPV candidate vaccine and Gardasil HPV vaccine. Results In statistical analysis, the two reporter gene systems for the detection of the pseudovirus neutralizing antibody titer are highly relevant to each other (Spearman coefficient; r = 0. 760). And their neutralizing antibody titers bear a high degree of correlation with the antibody titer (Spearman coefficient: r= 0.577 and r =0. 741). Conclusion ZsGreen and SEAP pseudovirus neutralizing antibody titers are highly relevant to each other. The neutralizing antibody and the antibody titer are also relevant. These results reveal some mechanism of HPV vaccines to prevent the virus from invading the host cells, and are absolutely useful in the protection efficiency evaluation of the HPV-16 and HPV-18 candidate vaccines. Key words: Pseudovirus; ZsGreen; SEAP; Neutralizing antibody titer

An update on safety of Gardasil from Denmark

In 2006, the FDA approved Gardasil — a quadrivalent human papillomavirus (HPV) vaccine — for use in girls and young women (age range, 9–26 years). The

Gardasil: update from US and Australia

Gardasil's Syncope Warning Bolstered

FDA Strengthens Syncope Warning on Gardasil Label