Human Papillomavirus Vaccine Type 16/ Type 18

Registered South African indications:

• Prevention of persistent infection, premalignant ano-genital lesions  cervical, vulvar, vaginal and anal) and cervical, vulvar, vaginal and anal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV)

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

• Breastfeeding
• Elderly
• Acute severe febrile illness
• Intravascularly or intradermal injection
• Thrombocytopenia 
• Coagulation disorders
• Immunosuppression

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Prevention of persistent infection, premalignant ano-genital lesions  cervical, vulvar, vaginal and anal) and cervical, vulvar, vaginal and anal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV)

• IM: 3 doses: 0.5ml at 0, 1, 6 months

If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose

Although the necessity for a booster dose has not been established, an anamnestic response has been observed after the administration of a challenge dose

Administer as intramuscular injection in the deltoid region

Paed. forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Prevention of persistent infection, premalignant ano-genital lesions  cervical, vulvar, vaginal and anal) and cervical, vulvar, vaginal and anal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV)

Younger than 9 years

• Not established for use

Between 9-14 years

• IM: 2 doses: Initial: 0.5ml; THEN 0.5ml, 5-13 months after the first dose

Older than 15 years

• See adult dosage

If the second vaccine dose is administered before the 5th month after the first dose, a third dose should always be administered

Although the necessity for a booster dose has not been established, an anamnestic response has been observed after the administration of a challenge dose

Administer as intramuscular injection in the deltoid region

Pregnancy

South African recommendations

• Caution
• Women who are pregnant or trying to become pregnant, are advised to postpone vaccination until completion of pregnancy
• The effect of HPV vaccination on embryo-foetal, peri-natal and post-natal survival and development has been assessed in rats. Such animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development
• Data in pregnant women collected as part of clinical trials, pregnancy registries and epidemiological studies do not suggest that vaccination with human papillomavirus vaccine: type 16/ type 18 alters the risk of abnormal outcomes in neonates including birth defects. Data are insufficient to conclude whether or not vaccination affects the risk of spontaneous abortion

Breastfeeding

South African recommendations

• Caution
• The effect on breastfed infants of the administration of human papillomavirus vaccine: type 16/ type 18 to their mothers has not been evaluated in clinical studies
• Human papillomavirus vaccine: type 16/ type 18 should only be used during breastfeeding when the possible advantages outweigh the possible risks
• Serological data suggest a transfer of anti-HPV16 and anti-HPV18 antibodies via the milk during the lactation period in rats. However, it is unknown whether vaccine-induced antibodies are excreted in human breast milk

Fertility

South African recommendations

• No information available

• No dose adjustment recommended

• No dose adjustment recommended

• Caution; no information available

Central Nervous System Disorders

• Headache
• Dizziness
• Syncope 
• Vasovagal responses to injection
• Tonic-clonic movements 

Respiratory Disorders

• Upper respiratory tract infection

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Abdominal pain

Musculoskeletal Disorders

• Myalgia
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Itching
• Pruritus
• Rash
• Urticaria
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Fever
• Allergic reactions 
• Angioedema

Systemic immunosuppressive agents

• Gynaecological examination
• Papillomavirus test

Human papillomavirus vaccine is a non-infectious recombinant vaccine prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein of oncogenic human papilloma virus types 16 and 18. Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response and cell-mediated immune memory.

Injection 0.5ml

• Cervarix (GSK) originator