Hib Vaccine (Hiberix) is a Haemophilus Influenzae Type B Conjugate Vaccine that induces active immunity against Haemophilus Influenza Type B. It is indicated to prevent invasive disease caused by Hib in patients at risk such as those with functional or anatomic asplenia, HIV infection, hypogammaglobulinemia, and patients with complement deficiency.

Haemophilus Influenzae Type B Conjugate Vaccine (Hiberix) Uses:

• Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b (Hib):

  • ActHIB:
    • vaccination of newborns and kids between the ages of 2 and 5.
  • Hiberix:
    • vaccination of newborns and kids from six weeks to four years old (before 5 years of age).
  • PedvaxHIB:
    • routine immunisation of babies and kids between the ages of 2 and 71 months.

  • The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following:

    • Through the age of 59 months, all newborns and kids should have their regular shots.
    • Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children aged 12 to 59 months, including those who have had chemotherapy, anatomical or functional asplenia, HIV infection, immunoglobulin deficiency, or early component complement insufficiency (including sickle cell disease).

  • There are no published effectiveness data for use in older kids and people with chronic illnesses linked to a greater risk of Hib disease. However, use could be thought about for:

    • Children under the age of five, teenagers, and adults with functional or anatomic asplenia who are unvaccinated (defined as those who have not had a primary series and booster dose or at least one dose of a Hib vaccination after the age of 14 months) (including sickle cell disease).
    • Children under the age of five, teenagers with HIV infection, and people who have never received a primary series, booster dose, or at least one dose of the Hib vaccine after the age of 14 months.
    • Young children receiving chemotherapy or radiation therapy
    • Successful recipients of hematopoietic stem cell transplants
    • Teenagers and young children having an elective splenectomy

Hib Vaccine (Hiberix) Dose in Adults:

Immunization: IM:

• Any of the Hib conjugate vaccines may be used by adults who have not received the childhood Hib series and who are more susceptible to invasive
• ACIP recommendations:
  • One dose (0.5 mL);
  • Hib disease due to sickle cell disease, anatomical or functional asplenia, or splenectomy.
• Adults who received successful hematopoietic stem cell transplant:
  • Regardless of prior vaccinations, revaccinate with a 3-dose schedule starting 6–12 months after the donation.
  • Doses need to be given about four weeks apart.

Hib Vaccine (Hiberix) Dose in Children:

Hib Vaccine (Hiberix) Dose for Primary immunization:

Note:

• Beginning at two months of age, preterm children should receive vaccinations in accordance with their chronological ages. The number of doses required to finish the Hib series depends on the product, including some combination formulations (3 doses: ActHIB, Hiberix; 2 doses: PedvaxHIB).

• Infants 6 weeks to 6 months:

  • The minimum age for the first dose is 6 weeks.
  • ActHIB, Hiberix (PRP-T):
    • IM: 0.5 mL per dose for a total of 3 doses administered as follows:
      • 2, 4, and 6 months of age
  • PedvaxHIB (PRP-OMP):
    • IM: 0.5 mL per dose for a total of 2 doses administered as follows:
      • 2 and 4 months of age

Hib Vaccine (Hiberix) Dose for Booster immunization:

• ACIP recommendation: ActHIB, Hiberix, PedvaxHIB:

  • Children 12 to 15 months:
    • IM: 0.5 mL as a single dose.

Hib Vaccine (Hiberix) Dose for Catch-up immunization:

Note:

• Avoid starting the series over.
• If doses have already been administered, consult the most recent immunisation recommendations for the precise schedule and timing of doses based on the patient's age and the total number of doses previously received.

• Infants and Children 4 to 59 months:

  • IM: 0.5 mL per dose for a total of 1 to 4 doses:
• Unvaccinated children and adolescents under the age of five who have undergone splenectomy, immunoglobulin deficit, HIV infection, early component complement deficiency, chemotherapy, or radiation therapy are at an increased risk for developing invasive Hib illness:
  • IM: 0.5 mL as a single dose; any Hib conjugate vaccination is acceptable.
  • A person who has not received a primary series, booster dose, or at least one dose of the Hib vaccine after the age of 14 months is said to be unimmunized.

Hib Vaccine (Hiberix) Dose for repeat immunization of high-risk conditions:

• Invasive Hib disease:

  • Infants and Children <24 months:
    • Beginning four weeks following the start of the disease, revaccinate with a second primary series.

• Undergoing chemotherapy or radiation therapy:

  • Infants and Children <60 months:
    • if the dosage is started or given during therapy within two weeks:
      • At least three months after the end of the therapy, repeat the doses.

• Hematopoietic stem cell transplant recipient:

  • Children and Adolescents:
    • Regardless of prior vaccinations, revaccinate with a 3-dose course starting 6 to 12 months after a successful transplant.
    • Doses need to be given about four weeks apart.

Hib Vaccine (Hiberix) Pregnancy Risk Category: C

• Studies on animal reproduction have not been done. It has not been proven that inactivated vaccines increase the risk to the foetus.

The administration of the Haemophilus influenzae type B conjugate vaccination while nursing

• The administration of the medication does not affect breastfeeding safety for either the mother nor the infant.
• Breastfeeding reduces infant fever that is associated with routine childhood vaccinations.
• Infants who are being breastfed must receive their necessary vaccinations on time.

Dose in Kidney Disease:

No dosage adjustments provided in the manufacturer’s labeling.

Dose in Liver disease:

No dosage adjustments provided in the manufacturer’s labeling.

Common Side Effects of Hib Vaccine (Hiberix):

• Central Nervous System:

  • Irritability
  • Drowsiness

• Gastrointestinal:

  • Anorexia

• Local:

  • Pain At Injection Site
  • Erythema At Injection Site
  • Swelling At Injection Site
  • Tenderness At Injection Site

• Miscellaneous:

  • Fever

Less Common Side Effects Of Hib Vaccine (Hiberix):

• Central Nervous System:

  • Excessive Crying
  • Pain

• Dermatologic:

  • Skin Rash

• Gastrointestinal:

  • Diarrhea

• Local:

  • Local Soreness/Soreness At Injection Site
  • Induration At Injection Site

• Otic:

  • Otitis Media

• Respiratory:

  • Upper Respiratory Tract Infection

• Miscellaneous:

  • Crying

Side effects of Hib Vaccine (Hiberix) - Frequency Not Defined:

• Central Nervous System:

  • Guillain-Barré Syndrome

• Gastrointestinal:

  • Vomiting

• Infection:

  • Bacterial Infection (Hib Early-Onset)

Contraindications to Hib Vaccine (Hiberix):

Hypersensitivity to the formulation, the Tetanus Toxoid component of the vaccine (Hiberix or ActHIB alone), and the Haemophilus B polysaccharide

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions

  • Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions must be available during vaccine use.

• Syncope

  • Syncope can be caused by injectable vaccines. It is most common in young adults and adolescents, and usually occurs within 15 minutes of vaccination.
  • It is important to take precautions to prevent injuries from falling, and to restore cerebral perfusion in the event of syncope.

• Acute illness:

  • The severity of the symptoms and the etiology are key factors in deciding whether to give or defer vaccinations due to current or recent febrile disease.
  • Vaccines should be administered as soon as feasible to patients with severe or moderate acute illnesses.
  • Patients with modest acute illnesses shouldn't postpone their administration, fever or not.

• Bleeding disorders:

  • Patients with a history bleeding disorder (including thrombocytopenia) should be cautious. IM administration may cause bleeding/hematoma.
  • If the patient has received antihemophilic therapy or another similar therapy, IM injections can be scheduled within a few hours.

• Guillain-Barre syndrome (GBS):

  • ActHIB and Hiberix patients with a history of GBS should be treated with caution.
  • Be sure to carefully weigh the advantages and disadvantages of immunisation for people who have recently experienced GBS.

• Tetanus immunization:

  • Tetanus shots are still necessary and are not replaced by the ActHIB/Hiberix vaccine.

Monitoring parameters:

• Monitor for anaphylaxis and syncope for 15 minutes after administration.
• If seizure-like activity associated with syncope occurs, maintain the patient in supine or Trendelenburg position to maintain adequate cerebral perfusion.

How to administer the Hib Vaccine (Hiberix)?

For IM administration;

Do Not Inject IV, intradermally, or subcutaneously

• Shake firmly before using.
• administer into the deltoid or anterior thigh.
• Due to the possibility for sciatic nerve damage, avoid administering into the gluteus.
• Use different needles and syringes for each injection; do not combine with other injections or immunizations.
• Patients should receive their vaccinations while sitting or lying down to reduce the risk of syncope-related injuries.

ActHIB, PedvaxHIB:

• Regardless of the time between doses, the major series does not need to be restarted if it is postponed or interrupted.

Hiberix:

• In the event that Hiberix is accidentally delivered during the primary vaccine series, the dose can be considered a legitimate PRP-T dose and, if given on schedule, does not require a repeat administration.
• In this instance, the primary series is finished with a total of three doses.
• The vaccine should only be injected intramuscularly at the treating physician's clinical discretion in individuals who are at risk of haemorrhaging after intramuscular administration.
• The intramuscular vaccination might be given soon after the patient has undergone antihemophilic or another equivalent therapy.
• For the immunisation, use a fine needle (23 gauge or smaller) and apply firm pressure to the location (without rubbing) for at least two minutes.
• The possibility of a hematoma from the injection should be discussed with the patient.
• Anticoagulant therapy patients should be handled similarly to people with clotting factor abnormalities and should be thought of as having the same bleeding risks.

Mechanism of action of Hib Vaccine (Hiberix):

• It increases anticapsular antibody synthesis and offers Haemophilus influenzae Type b active immunity.
• For more than 95% of infants who have received a 2- or 3-dose series of vaccinations, the vaccine produces protective antibodies (CDC 2012).
• An anti-PRP concentration >=1.0 mg/mL indicates long-term protection.

The beginning of action:

• Each dose increases your immunity.
• After the completion of the initial series, immunity can be inferred within two weeks.

Efficacy:

• Children between the ages of 18 and 24 months experienced a 45%-88% drop in illness incidence after receiving the initial unconjugated Hib vaccination.
• The early Hib vaccinations were protein-conjugated and offered newborns >90% protection after a multidose series.
• After the initial Hib conjugate vaccines were approved, all later formulations were approved based on non-inferior antibodies.

Time:

• Clinical protection against disease is indicated by antibody concentrations greater than 0.15 mcg/mL.
• Long-term protection against disease is usually achieved when antibodies concentrations exceed 1 mcg/mL. This protection can last for several years.

International Brands of Haemophilus Influenzae Type B Conjugate Vaccine:

• ActHIB
• Hiberix
• PedvaxHIB
• HIBest
• HibTITER
• Pedvax HIB

Haemophilus Influenzae Type b Conjugate Vaccine Brand Names in Pakistan: