By Medifit Biologicals


Recombinant Human Papillomavirus Vaccines


1.       TYPE OF DRUG- Recombinant Human Papillomavirus Vaccines
Human papilloma virus (HPV) vaccines are vaccines that prevent infection by certain types of human papillomavirus.


2.       INDICATIONS (USE)- Recombinant Human Papillomavirus Vaccines
Prevention of cervical cancer caused by HPV types 16 and 18 ; prevention of incident and persistent infections caused by HPV typea 16 and 18 ; prevention of cytologicals abnormalities including atypical squamous cells of undetermined significance caused by HPV types 16 and 18 ;prevention of central intraepithelial neoplasia,cin1 and pre-cancerous lesions caused by HPV types 16 and 18 ;prevention of adenocarcinoma in situ caused by hpv types 16 and 18


3.       MECHANISM OF ACTION (MOA)- Recombinant Human Papillomavirus Vaccines
The HPV vaccines are based on hollow virus-like particles (VLPs) assembled from recombinant HPV coat proteins. The virus possesses circular double stranded DNA and a viral shell that is composed of 72 capsomeres. Every subunit of the virus is composed of two proteins molecules, L1 and L2. The reason why this virus has the capability to affect the skin and the mucous layers is due to its structure. The primary structures expressed in these areas are E1 and E2, these proteins are responsible for the replication of the virus. E1 is a highly conserved protein in the virus, E1 is in charge of the production of viral copies is also involved in every step of replication process. The second component of this process is E2 ensures that non-specific interaction occur while interacting with E1. As a result of these proteins working together is assures that numerous amounts of copies are made within the host cell. The structure of the virus is critical because this influence the infection affinity of the virus. Knowing the structure of the virus allowed for the development of an efficient vaccine, such as Gardasil and Cervarix. The vaccines target the two high-risk HPVs, types 16 and 18 that cause the most cervical cancers. Gardasil’s proteins are synthesized by the yeast Saccharomyces cerevisiae. Its protein makeup allows it to target four types of HPV. Gardasil contains inactive L1 proteins from four different HPV strains: 6, 11, 16, and 18. Each vaccine dose contains 225 µg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 µg of polysorbate 80, 35 µg of sodium borate, and water. The combination of ingredients totals 0.5 mL. Together, these two HPV types currently cause about 70 percent of all cervical cancer. Gardasil also targets HPV types 6 and 11, which together currently cause about 90 percent of all cases of genital warts.

Gardasil and Cervarix are designed to elicit virus-neutralizing antibody responses that prevent initial infection with the HPV types represented in the vaccine. The vaccines have been shown to offer 100 percent protection against the development of cervical pre-cancers and genital warts caused by the HPV types in the vaccine, with few or no side effects. The protective effects of the vaccine are expected to last a minimum of 4.5 years after the initial vaccination.


4.       ROUTES OF ADMINISTRATION- Recombinant Human Papillomavirus Vaccines
HPV vaccine should be administered intramuscularly.


5.       ONSET OF EFFECT OR ACTION- Recombinant Human Papillomavirus Vaccines
6.     DOSAGE (DOSING INFORMATION)- Recombinant Human Papillomavirus Vaccines
Each dose of HPV vaccine is 0.5 ml.


7.       HALF LIFE (DURATION OF ACTION)- Recombinant Human Papillomavirus Vaccines


8.       ADVERSE EFFECTS OR SIDE EFFECTS – Recombinant Human Papillomavirus Vaccines
  • Pain, redness, or swelling in the arm where the shot was given
  • Fever
  • Headache or feeling tired
  • Nausea
  • Muscle or joint pain


9.       CONTRAINDICATIONS – Recombinant Human Papillomavirus Vaccines
Hypersensitivity postpone admin in patient suffering from an actul febrile illness.


10.   DRUG INTERACTIONS – Recombinant Human Papillomavirus Vaccines
Immunosuppressive therapies e.g. irradiation ,cytotoxic drugs and corticorsteroids may reduce a patients immune response to the vaccine.


11.    EXCRETION- Recombinant Human Papillomavirus Vaccines
Excreted in human milk.



By Medifit Biologicals