PapilloGuard4^® is a quadrivalent recombinant HPV vaccine, developed and manufactured by Nivad Pharmed Salamat, designed to prevent infection with HPV types 6, 11, 16, and 18, and the associated diseases caused by these strains in males and females aged 9 to 45 years. With strong immunogenicity, a favorable safety profile, and robust outcomes demonstrated in clinical trials, PapilloGuard4^® represents a significant advancement in public health.

Vaccination is considered the most effective approach to preventing both low-risk and high-risk HPV infections, thereby reducing the incidence of genital warts and HPV-related cancers. Vaccination is recommended as follows:

HPV vaccines can be given starting at age 9. Children ages 9-14 years should get 2 doses of HPV vaccine, given 6 to 12 months apart. Only 2 doses are needed if the first dose was given before 15th birthday.

Children 9–14 years old who have received 2 doses of HPV vaccine less than 5 months apart will need a third dose.
People 15–26 years old who start the series later need 3 doses of HPV vaccine.
– The doses are given over 6 months.
– If your teen isn’t vaccinated yet, talk to their doctor about doing so as soon as possible.
People with weakened immune systems should get 3 doses if they are 9–26 years old.
People older than 26 years:
– Some adults age 27 through 45 years who are not already vaccinated may decide to get HPV vaccine after speaking with their doctor about their risk for new HPV infections and the possible benefits of vaccination for them.

HPV vaccines can be given starting at age 9. Within the recommended age range, the optimal time for HPV immunization is prior to an individual’s sexual debut. Centers for Disease Control and Prevention (CDC) recommends routine vaccination of preteens at ages 11 or 12 years.

PapilloGuard4® is administered as a 0.5 mL intramuscular injection using a prefilled syringe. Before injection, PapilloGuard4® should be well shaken to create a white, cloudy, homogeneous suspension. The product should not be used if suspended particles or discoloration are present.

PapilloGuard4^® must be stored at a temperature of 2 to 8 °C under proper cold-chain conditions. Freezing should be avoided.
PapilloGuard4® should be administered as soon as possible after being taken out of the refrigerator.
This vaccine should not be used after the expiration date stated on the box.

PapilloGuard4^® must be administered intramuscularly, either into the deltoid muscle of the upper arm or the anterolateral area of the thigh. Among these sites, the deltoid muscle is the preferred location. HPV vaccines must not be administered intravenously, subcutaneously, or intradermally.

The suspension should be well shaken before use. It should not be used if discolored, if particulate matter is present, or if the syringe is cracked.
The entire dose should be injected intramuscularly into the deltoid region of the upper arm or the higher anterolateral thigh area. When using the deltoid muscle, proper injection technique (e.g., injecting into the central, thickest part of the muscle) should be employed to reduce the risk of shoulder injury related to vaccine administration.
HPV vaccine may be given at the same time as other vaccines. The vaccine should not be mixed with other vaccines or injections; separate needles and syringes must be used for each injection.
Vaccination should be performed while the patient is seated or lying down.
The vaccinated individual should be observed for at least 15 minutes following injection.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient’s bleeding risk, it can be given with reasonable safety.
If the patient is receiving antihemophilia or similar therapy, intramuscular vaccination should be scheduled shortly after such therapy has been administered. Firm pressure (without rubbing) should be applied to the injection site for at least 2 minutes. The patient should be instructed regarding the risk of hematoma following injection. Patients receiving anticoagulant therapy should be considered to have the same bleeding risk and treated in the same manner as those with clotting factor disorders.

• Anaphylaxis:
  • Rare but potentially life-threatening. Immediate access to emergency medications, including epinephrine, is essential. Clinics must be equipped to manage such reactions at the time of vaccination.
• Shoulder Injury:
  • Incorrect injection too high above the deltoid may cause shoulder injury (eg, shoulder bursitis or tendinitis) resulting in, restricted mobility, and pain. The vaccine must be administered into the central, thickest part of the deltoid muscle.
• Syncope:
  • Can occur immediately after vaccination, particularly in adolescents, and may lead to serious injury such as head trauma. This reaction is not specific to HPV vaccines and may also be observed with other immunizations.

  • Prevention:

    • Vaccination should be performed while the patient is seated or lying down, and the vaccinated individual must be observed for at least 15 minutes following administration.

  • Management in:
    • If seizure-like activity associated with syncope occurs, the patient should be maintained in the supine or Trendelenburg position to reestablish adequate cerebral perfusion.

• Acute illness: In individuals with moderate to severe acute illness (with or without fever), vaccination should be postponed. Mild illness does not require deferral.
• Bleeding disorders / anticoagulation: In patients with “bleeding disorders (including thrombocytopenia) or those receiving anticoagulant therapy, vaccination should be administered cautiously and under medical supervision. Bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered.
• Immunosuppressive therapy: Inactivated vaccines should be administered at least 2 weeks prior to initiation of immunosuppressive drugs (e.g., systemic corticosteroids) or chemotherapy. If patients are vaccinated less than 14 days prior to or during such therapy, the dose should be repeated, if possible, after completion of treatment, once immunocompetence has been restored.

No. PapilloGuard4^® may be administered concomitantly with other age-appropriate vaccines (both live and inactivated), using different anatomical injection sites. To minimize local adverse effects, such as injection-site pain, it is recommended that PapilloGuard4^® be given as the final injection during the visit.

HPV vaccination is not recommended during pregnancy due to limited safety data. However, available evidence from inadvertent administration during pregnancy and does not indicate increased risk of adverse outcomes. If a woman becomes pregnant after starting the series, the remaining doses should be deferred until pregnancy is completed.

Yes. HPV vaccination is not contraindicated during breastfeeding. Women who are breastfeeding or planning to breastfeed should consult their healthcare provider prior to vaccination to weigh the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination for the mother.

Studies on the durability of HPV vaccines are still ongoing. To date, immunity has been reported to last for at least 10 years, and a booster dose is not required for this vaccine.

No; there is no need to perform HPV screening before vaccination. Screening tests for cervical cancer and other recommended evaluations should be continued according to guidelines, after vaccination, as part of routine care.

Yes; this vaccine is indicated for the prevention of HPV-related diseases in both women and men between 9 and 45 years of age.

HPV vaccination is not yet included in Iran’s national immunization program. However, given the prevalence of the virus and vaccination important role in the prevention of cervical cancer and other malignancies, it is hoped that it will be incorporated into the program in the near future. The Iranian PapilloGuard4^® vaccine, developed by Nivad Pharmed Salamat, with proven immunogenicity, established safety, affordability, and consistent availability, making it a reliable option for HPV prevention. In a Phase III clinical trial, the immunogenicity and safety of PapilloGuard4^® were evaluated in comparison with the quadrivalent reference vaccine (Gardasil^®) in 670 women and men aged 15 to 25 years. The results demonstrated strong immune responses and a favorable safety profile. These results highlight the potential public health impact of PapilloGuard4® in lowering the incidence of HPV-related diseases.