Human Papillomavirus Quadrivalent Vaccine, Recombinant

Usage

• Medical Conditions: Human Papillomavirus Quadrivalent Vaccine, Recombinant (4vHPV) is prescribed for the prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, and 18. This includes the prevention of:
  • Cervical, vulvar, vaginal, and anal cancers (caused by HPV types 16 and 18).
  • Genital warts (condyloma acuminata) (caused by HPV types 6 and 11).
  • Precancerous or dysplastic lesions caused by these HPV types.
• Pharmacological Classification: Vaccine (viral vaccine).
• Mechanism of Action: The vaccine stimulates an immune response by producing virus-like particles (VLPs) composed of the L1 protein of the HPV types. These VLPs resemble the outer coat of the virus but lack viral DNA, therefore cannot cause infection. This induces the body to produce antibodies, which protect against future infection with the covered HPV types.

Alternate Names

• Quadrivalent HPV Vaccine, Recombinant
• qHPV
• GARDASIL (brand name, now discontinued in Canada)
• CERVAVAC (brand name in India)

How It Works

• Pharmacodynamics: The vaccine triggers the production of neutralizing antibodies against HPV types 6, 11, 16, and 18. These antibodies prevent the virus from infecting cells.
• Pharmacokinetics: The vaccine is administered intramuscularly. The VLPs are taken up by antigen-presenting cells, leading to the production of antibodies. The specific absorption, metabolism, and elimination pathways for the components of the vaccine have not been fully characterized.
• Mode of Action: The L1 VLPs mimic HPV particles, stimulating an adaptive immune response without causing infection. B cells are activated and differentiate into plasma cells, which produce specific antibodies against each of the four HPV types. Memory B cells are also produced, which provide long-lasting immunity by recognizing and responding rapidly to subsequent exposure to these HPV types.
• Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: The vaccine does not directly interact with receptors, enzymes, or neurotransmitters. Its mechanism involves stimulating an immune response through VLP recognition by antigen-presenting cells.
• Elimination Pathways: The elimination pathways for vaccine components have not been fully elucidated.

Dosage

Standard Dosage

Adults (15 through 45 years):

• 0.5 mL intramuscularly, administered as a 3-dose series at 0, 1-2 and 6 months.

Children (9 through 14 years):

• 0.5 mL intramuscularly, administered as a 2-dose series at 0 and 6-12 months. A minimum interval of 5 months is required between doses. If the second dose is administered earlier than 5 months after the first dose, a third dose should be administered at least 12 weeks after the second dose and 5 months after the first dose.

Special Cases:

• Elderly Patients (over 45 years old): Not routinely recommended. Shared decision-making with a healthcare provider is recommended for adults aged 27-45.
• Patients with Renal Impairment: No dose adjustment is specifically recommended, but caution is advised.
• Patients with Hepatic Dysfunction: No dose adjustment is specifically recommended, but caution is advised.
• Patients with Comorbid Conditions: No specific dosage recommendations based on comorbidities but clinical judgment should be used.
• Immunocompromised Individuals (9 years and older): A 3-dose schedule (0, 1-2, and 6 months) is recommended.

Clinical Use Cases

The HPV quadrivalent vaccine is not indicated for use in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. It is solely for the prevention of HPV-related conditions.

Dosage Adjustments

Dose adjustments may be necessary for certain populations, as indicated above, particularly for immunocompromised individuals. Always consult the latest clinical guidelines for specific dosage recommendations.

Side Effects

Common Side Effects:

• Injection site reactions (pain, redness, swelling)
• Headache
• Fever
• Fatigue
• Nausea
• Muscle or joint pain

Rare but Serious Side Effects:

• Severe allergic reactions (anaphylaxis)
• Syncope (fainting), sometimes with tonic-clonic movements
• Seizures

Long-Term Effects: Data on long-term effects are limited, but no serious long-term side effects have been definitively linked to the vaccine.

Adverse Drug Reactions (ADR):

• Anaphylaxis requires immediate medical intervention.

Contraindications

• History of severe allergic reaction (anaphylaxis) to a previous dose of any HPV vaccine or any vaccine component
• Severe allergy to yeast (relevant for 9vHPV, but may indicate sensitivity to 4vHPV components)
• Pregnancy (although inadvertent administration is not a reason for termination)

Drug Interactions

• Can be co-administered with other vaccines, but should be given at different injection sites with separate syringes.
• No data on concomitant use with potent immunosuppressants.
• No known significant interactions with commonly prescribed medications, OTC drugs, supplements, or food.

Pregnancy and Breastfeeding

• Pregnancy Safety Category: Not recommended during pregnancy. Inadvertent administration does not warrant termination of pregnancy. Postpone subsequent doses until after pregnancy.
• Fetal Risks, Teratogenicity, and Developmental Concerns: Limited data suggest no increased risk of adverse pregnancy or fetal outcomes.
• Drug Excretion in Breast Milk: It is unknown if vaccine antigens are excreted in breast milk. The vaccine can be given to breastfeeding women.

Drug Profile Summary

• Mechanism of Action: Stimulates an immune response against HPV types 6, 11, 16, and 18 by producing VLPs resembling the outer coat of the virus.
• Side Effects: Common side effects include injection site reactions, headache, fever, fatigue, and nausea. Rare but serious side effects include anaphylaxis and syncope.
• Contraindications: Hypersensitivity to vaccine components, yeast allergy, pregnancy.
• Drug Interactions: Can be co-administered with other vaccines using separate syringes and injection sites. No data on concomitant use with potent immunosuppressants.
• Pregnancy & Breastfeeding: Not recommended during pregnancy. Can be given to breastfeeding women.
• Dosage: Two doses for ages 9-14, three doses for ages 15-45.
• Monitoring Parameters: Observation for 15 minutes post-vaccination to monitor for syncope.

Popular Combinations

The quadrivalent HPV vaccine is often administered with other vaccines as part of routine childhood immunization schedules, such as Tdap, hepatitis B, and meningococcal vaccines. It should not be mixed with any other vaccine in the same syringe.

Precautions

• General Precautions: Screen for contraindications and precautions before administering the vaccine. Observe patient for 15 minutes post-vaccination for syncope.
• Specific Populations: See information provided above regarding pregnancy, breastfeeding, children, and elderly. No special precautions exist for menstruating individuals.
• Lifestyle Considerations: No specific lifestyle considerations.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Human Papillomavirus Quadrivalent Vaccine, Recombinant?

A: The recommended dosage varies by age and immune status. For ages 9 through 14, a 2-dose schedule at 0 and 6-12 months is recommended. For ages 15 through 45, a 3-dose schedule at 0, 1-2, and 6 months is recommended. Immunocompromised individuals 9 years and older should receive a 3-dose schedule.

Q2: Can 4vHPV prevent all types of HPV?

A: No. It only protects against HPV types 6, 11, 16, and 18. Other HPV vaccines, such as the 9-valent HPV vaccine (9vHPV or GARDASIL 9), cover additional HPV types.

Q3: What should I do if a patient faints after receiving the vaccine?

A: Have the patient lie down and elevate their legs. Monitor vital signs and ensure adequate cerebral perfusion. If the syncope is associated with seizure-like activity, manage appropriately and observe until symptoms resolve.

Q4: Can the vaccine be administered during pregnancy?

A: It is not recommended for use during pregnancy. However, if a woman is found to be pregnant after starting the series, the remaining doses should be delayed until after pregnancy. Inadvertent administration during pregnancy is not a reason to terminate the pregnancy.

Q5: Is it safe to breastfeed while receiving the vaccine?

A: Yes. Available evidence suggests that the vaccine is safe for breastfeeding mothers and their infants.

Q6: Can the vaccine treat existing HPV infections or HPV-related cancers?

A: No. The vaccine is strictly prophylactic and does not treat existing HPV infections or diseases.

Q7: What are the most common side effects of the vaccine?

A: Injection site reactions (pain, redness, swelling), headache, fever, fatigue, and nausea are common.

Q8: How long does protection from the vaccine last?

A: Current data suggests that protection is long-lasting, but the need for a booster dose has not yet been established.

Q9: What is the difference between the quadrivalent and 9-valent HPV vaccines?

A: The quadrivalent vaccine (4vHPV) protects against four HPV types (6, 11, 16, and 18), whereas the 9-valent vaccine (9vHPV) protects against nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58), offering broader protection.

As of today, February 16, 2025, this information is current, but medical knowledge is constantly evolving. Always refer to the latest medical guidelines and prescribing information for the most up-to-date recommendations.