Cervarix

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Cervarix HPV Vaccine Bivalent Recombinant Types 16 and 18' “The adjuvant system, AS04, is composed of 3-O-desacyl-4’-monophosphoryl lipid A (MPL) adsorbed on to aluminum (as hydroxide salt).

Found 4459 cases where Vaccine is HPV2 and Manufacturer is GLAXOSMITHKLINE BIOLOGICALS Cervarix here

October 26, 2017 – Adjuvants and the vaccine response to the DS-Cav1-stabilized fusion glycoprotein of respiratory syncytial virus (RSV) (full text) “The most common adjuvant, alum, comprised of aluminum salts, has been used in humans since 1932, is the only FDA approved adjuvant for human use. To assess the impact of different adjuvants, here we formulated RSV F DS-Cav1 with multiple adjuvants and assessed immune response.  TLR4 agonist, MPLA, combined with Alum is used for the EU hepatitis B vaccine, Fendrix,and the human papillomavirus (HPV) vaccine, Cervarix. Oil-in-water formulations such as MF59 are components of FLUAD (a new seasonal flu vaccine for the elderly) MPLA is also a component of Pollinex Quattro, a vaccine used for the treatment of seasonal allergic rhinitis.”… All these groups will have been primed by natural infection, so the role of adjuvant is primarily to 'increase the magnitude of the response based on the established precursor T cell and B cell populations. For pregnant women, vaccination should avoid excessive Th1-biased responses for safety concerns related to the pregnancy. If adjuvants are needed to boost antibody responses to protective levels in adults, alum-based formulations may' have acceptable safety and immunological profile for use in pregnancy. In the elderly or older children, the most potent, tolerable adjuvant should be chosen based on results from early phase clinical trials.”  Comment: This full-text article is worth skimming. Note that exposure to RSV and resistance to infection was not tested. The article is additional documentation that the one thing investigators are interested in knowing is the antibody response induced by tinkering with the immune system. It is “assumed” that a high antibody level will protect a person from becoming ill. 



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'December 12, 2014 – Anti-Cancer Vaccines — A One-Hit Wonder? (full text) “In terms of drawbacks to the vaccines themselves, there have been side effects reported after vaccine administration. One of the biggest fears is the lack of selectivity of TAAs that can potentially lead to autoimmunity occurring in the patient. For example, cases of vitiligo (a condition that results in blotches of pigmentation loss in the skin) have been reported in patients receiving a melanoma vaccine.” ... ”Examples of anti-cancer vaccine adjuvants currently approved for use in clinical practice include aluminum salts (alum), monophosphoryl lipid A (MPL) in an oil-in-water emulsion (known as MF59), and a combination of MPL and alum known as AS04. Alum and oil-in-water emulsions both act as a vehicle, delivering and controlling the release of the vaccine antigen to the host immune system. They can also directly stimulate the innate immune system through an inflammatory response, which, in turn, facilitates and amplifies a cell-mediated or humoral immune response. MPL is derived from lipopolysaccharide (LPS), a pattern-associated molecular pattern (PAMP) recognized by a pattern recognition receptor (PRR), Toll-like receptor 4 (TLR4) [49]. AS04 is licensed for use as an adjuvant in Fendrix (a HBV vaccine) and Cervarix (a HPV vaccine).

January 29, 2010 – Currently Approved Prophylactic HPV Vaccines (free registration)  Vaccine composition. Comment: The amount of aluminum in Gardasil vs Cervarix vaccines.

  Cervarix (GlaxoSmithKline) Gardasil (Merck)
Vaccine type

HPV-16 and HPV-18 VLP

L1 capsid component

HPV-6/11/16/18 VLP

L1 capsid component

Concentration

20 µg HPV-16

20 µg HPV-18

20 µg HPV-6

40 µg HPV-11

40 µg HPV-16

20 µg HPV-18

Adjuvant

AS04:

500 µg aluminum hydroxide, 50 µg 3-deacylated monophosphoryl lipid A

Alum:

225 µg aluminum hydroxyphosphate sulfate

Recombinant technology substrate system expression system in cells Yeast expression system in Saccharomyces cerevisiae


July 1, 2009 – Dangers of HPV Vaccine Production in Plants, Microbes, and Viruses The Cervarix vaccine available commercially is produced by GlaxoSmithKline using a baculovirus vector propagated in an insect cell line. Baculoviruses are soil inhabiting viruses that infect insects. Baculovirus expression vectors propagated in insect cells were originally hampered by the appearance of many  interfering baculoviruses with chromosomal deletions, which arise as an intrinsic property of the native baculovirus. The intrinsic deletions in the viral chromosome may provide a source of diversity as the virus faces environmental challenges.  Such instability is undesirable in producing vaccines. Some progress has been achieved in making more stable baculovirus expression vector lines.  Nevertheless, regulators and the vaccine producer have not made public comment about the genetic stability of the baculovirus lines producing Cervarix vaccine, nor the fact that baculovirus is capable of  infecting mammalian cells and tissues. If the GM baculovirus infects mammalian cells and tissues in vivo, they would also transfer transgenes to those infected cells as gene therapy experiments have demonstrated since 2001. Baculovirus can also serve as a gene delivery vector for stem cell and bone tissue engineering.

August 15, 2007 - Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection (full text) "There was no evidence that HPV vaccination significantly altered rates of viral clearance; VEVC estimates overall ranged from −0.2% to 2.5% at the 6-month visit and from −3.7% to −2.0% at the 12-month visit. For HPV-16/18 infections, the VEVC estimates were 2.5% (95% CI, −9.8% to 13.5%) at the 6-month visit and −2.0% (95% CI, −24.3% to 16.3%) at the 12-month visit. No significant evidence of a vaccine therapeutic effect was observed in analyses restricted to women who received all doses of vaccine or those with evidence of single HPV infections at entry (Table 2).