Inactivated Poliomyelitis Vaccine

Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV

Connaught

Poliomyelitis Prophylaxis

Action And Clinical Pharmacology: Poliomyelitis is caused by infection with 1 of the 3 antigenic types of poliovirus. Following introduction of poliovirus vaccine in Canada in 1955, the indigenous disease has been virtually eliminated.

The last significant outbreak of poliomyelitis occurred in 1978 to 1979, when there were 11 cases of paralytic disease among unimmunized contacts of imported cases. The last case of poliomyelitis attributed to imported, wild virus occurred in 1988. However, circulation of wild viruses does occur in rare circumstances, and it remains crucial that the highest possible level of vaccine-induced immunity be maintained in the population. Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV, (sometimes referred to as e-IPV), is an enhanced formalin-inactivated product which has a higher potency than the original IPV. The 3 poliovirus types are propagated in human diploid cells. A primary series induces protective antibody levels in more than 99% of recipients.

The clinical data for Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV were obtained from 2 centres: one in Canada (British Columbia) and the other in the U.S. (Baltimore, Maryland). Serum samples from both sites were tested for neutralizing antibody of poliovirus Types 1, 2 and 3 by the micrometabolic inhibition test at Connaught Laboratories Limited.

The clinical trial data on 3 lots of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV obtained from a study on 338 infants in British Columbia demonstrated that 2 injections of vaccine at an interval of 2 months administered to infants 2 months of age at the time of the initial injection were effective in stimulating an antibody response to each of the 3 poliovirus types.

The response to Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV developed despite the presence of maternally-transmitted antibody in most of the infants at the time of the initial vaccine injection. Following the second injection of vaccine, detectable antibody (³1:4) was present in 99.7% (of 329 children) for Types 1 and 2 and in 98.8% (of 329 children) for Type 3.

In 294 children, the third vaccine injection at 15 to 18 months of age stimulated antibody rises to each of the 3 virus types to levels much higher than those attained following the second injection. The geometric mean responses 1 month after the third dose were 1:1 922, 1:4 010 and 1:1 388 for poliovirus Types 1, 2 and 3, respectively.

The data obtained in the Baltimore trials in a group of 254 infants demonstrated that 2 injections of vaccine at an interval of 2 months administered to infants 2 months of age at the time of the initial injection were effective in stimulating an antibody response to each of the 3 poliovirus types. Following the second vaccine injection, detectable antibody (³1:4) to Type 1 poliovirus was present in 98.8% of infants and antibody (³1:4) to Types 2 and 3 poliovirus was present in 99.2% of infants. The response to vaccine developed despite the presence of maternally-transmitted antibody in a high percentage of the infants at the time of the initial vaccine injection.

Indications And Clinical Uses: As an active immunizing agent to be administered, as described below, for the prevention of poliomyelitis.

Contra-Indications: General: Immunization with Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV should be deferred in the presence of any acute illness, including febrile illness. A minor afebrile illness such as mild upper respiratory infection is not usually reason to defer immunization.

Absolute Contraindications: Allergy to any component of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV (see Supplied) an anaphylactic or other allergic reaction to a previous dose of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV are contraindications to vaccination.

Elective immunization of persons over 6 months of age should be deferred during an outbreak of poliomyelitis because of the risk of provocation paralysis.

Manufacturers’ Warnings In Clinical States: The vaccine should be perfectly clear and colorless. Any vaccine showing particulate matter or turbidity should be discarded. If Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV is used in persons with malignancies receiving immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or who are otherwise immunocompromised (including HIV infected individuals), the expected immune response may not be obtained.

Corticosteroid therapy can result in immunosuppression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., ³2 mg/kg/day of prednisone orally for more than 2 weeks, should be considered to have a compromised immune system.

As with any vaccine, immunization with Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV may not protect 100% of susceptible individuals.

Precautions: General: Inactivated Poliomyelitis Vaccine is the vaccine of choice for immunizing immunodeficient patients and their household contacts. Although patients with immune deficiency diseases such as combined immunodeficiency, hypogammaglobulinemia and agammaglobulinemia, those with altered immune states due to diseases such as leukemia, lymphoma or generalized malignancy, and those with immune systems compromised by therapy with corticosteroids, alkylating drugs, antimetabolites or radiation may not develop a protective immune response, Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV should be administered. Because of the possibility of immunodeficiency in other members of a household in which there has been one such case, Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV should be used to immunize subsequent children until the immune status of the recipient and of other children in the family is documented.

Since the vaccine contains trace amounts of bovine serum and may contain trace amounts of polymyxin B and neomycin, the possibility of allergic reactions in individuals sensitive to these substances should be borne in mind when considering the use of this vaccine.

The possibility of allergic reactions in individuals sensitive to components of the vaccine should be evaluated. Epinephrine HCl solution (1:1 000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Health care providers should be familiar with current recommendations for the initial management of anaphylaxis in nonhospital settings, including proper airway management.

Before administration of any vaccine, all appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccine, determination of previous immunization history, and the presence of any contraindications to immunization, current health status, and a current knowledge of the literature concerning the use of the vaccine under consideration.

Special care should be taken to ensure that the product is not injected into a blood vessel.

Caution: A separate sterile needle and syringe, or a sterile disposable unit, must be used for each individual patient to prevent the transmission of infectious agents.

There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique. In particular, the same needle and/or syringe must never be used to re-enter a multidose vial to withdraw vaccine even when it is to be used for inoculation of the same patient. This may lead to contamination of the vial contents and infection of patients who subsequently receive vaccine from the vial.

Needles should not be recapped and should be disposed of properly.

Before administration of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV health care personnel should inform the parent or guardian or the patient to be immunized of the benefits and risks of immunization, inquire about the recent health status of the patient and comply with any local requirements with respect to information to be provided to the patient before immunization.

Pregnancy: No clinical trials with inactivated poliomyelitis vaccine have been conducted on pregnant women. Although there is no convincing evidence documenting adverse effects of inactivated poliomyelitis vaccine on the pregnant women or the developing fetus, it is prudent on theoretical grounds to avoid vaccinating pregnant women.

Adverse Reactions: Local reactivity at the injection site as observed during the Canadian Clinical Trials consisted of redness, hardness and pain or discomfort occurring in 14%, 4% and 12% of vaccinees, respectively, usually on the evening following injection and declining thereafter to minimal levels.

As both of the first and second Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV injections were administered at the same time, but at a different site from the first and second injections of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DPT Adsorbed) interpretation of systemic reactivity cannot be attributed solely to either vaccine. However, the systemic reactivity associated with administration of DPT Adsorbed in previous clinical trials would tend to indicate that the DPT Adsorbed was the major contributory factor.

Physicians, nurses and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and to the Medical Director, Connaught Laboratories Limited, 1755 Steeles Avenue West, Toronto, Ontario, Canada M2R 3T4.

Dosage And Administration: Primary immunization of infants at or above the age of 2 months, and children up to their 7th birthday: 3 doses of 0.5 mL each should be administered s.c. at intervals of 8 weeks, followed by a fourth dose of 0.5 mL approximately 12 months after the third dose.

In infancy, the primary schedule is usually integrated with DPT Adsorbed immunization, beginning at 8 to 12 weeks of age.

Primary immunization of older children (after their 7th birthday) and adults: 2 doses of 0.5 mL each administered s.c. 8 weeks apart, followed by a third dose of 0.5 mL , approximately 12 months after the second dose.

Booster Doses: All children who have received the initial 4 doses in infancy and in early childhood should be given a booster dose of 0.5 mL of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV before entering school.

If the fourth primary dose is administered on or after the fourth birthday, a fifth (supplementary) dose is not required at school entry.

Unless oral polio vaccine was used exclusively during the primary series and the boosting dose, the Canadian Immunization Guide recommends an additional dose at the age of 14 to 16 years. Further recall doses should be given every 10 years to persons at risk (e.g., travellers).

Adults: Routine immunization against poliomyelitis of adults living in Canada is not considered necessary.

Most adults are already immune and have a very small risk of exposure to wild polioviruses in North America. Immunization is recommended for certain adults who are at greater risk of exposure to poliovirus than the general population, including: travellers to areas or countries where poliomyelitis is epidemic or endemic; laboratory workers handling specimens which may contain polioviruses; health care workers in close contact with patients who may be excreting wild or vaccine strains of polioviruses; unvaccinated parents of infants and toddlers who are to be given OPV; unvaccinated child-care centre workers; sewage workers; residents of communities where routine immunization of infants and children has not been practised.

Adults and adolescents who are at greater risk of exposure to poliovirus than the general population (see above) may be given a single dose of IPV if more than 10 years have elapsed since the last dose of their complete IPV and/or OPV vaccination series.

Persons with incomplete or no immunization history under these categories should receive the remaining dose(s) of IPV regardless of the interval since the last dose (in the case of incomplete poliovirus vaccination). Non-vaccinated adults and adolescents at increased risk of exposure to poliovirus should receive the primary series of IPV. The recommended schedule is 2 doses given at a 1- to 2-month interval and a third dose given 6 to 12 months later.

The following special recommendations are made for circumstances where time will not allow at least 2 doses of IPV to be given before protection is required.

Travellers who will depart in less than 4 weeks should receive a single dose of IPV, or if not available, OPV. In both instances, the remaining doses of vaccine should be given later at the recommended intervals.

Unvaccinated parents or other household contacts of infants who are to be given OPV carry a very small risk of developing OPV-associated paralysis. It will generally not be practical for such persons to be fully protected with IPV before the infant is immunized, and the very small risk may be reduced by giving them one dose of IPV at the same time as the first dose is given to the infant. Arrangements should be made for the adults to complete their basic course of immunization.

Administration: Parenteral biological products should be inspected visually for extraneous particulate matter and/or discoloration before administration. If these conditions exist, the product should not be administered.

Shake the ampul well to distribute uniformly the solution before withdrawing each dose. Before withdrawing a dose from an ampul, tap the container first to ensure that any vaccine in the ampul neck falls to the lower portion of the ampul. Once the ampul has been opened, any of its contents not used immediately should be discarded. Aseptic technique must be used for withdrawal of each dose.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Do not inject i.v.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Availability And Storage: Each perfectly clear and colorless, purified inactivated vaccine contains: a solution of 3 types of poliovirus, Type 1 (Mahoney), Type 2 (M.E.F.1), Type 3 (Saukett), grown in human diploid strain MRC-5 cell cultures. Formaldehyde 27 ppm and 2-phenoxyethanol 0.5% added as preservative.

By calculation, the vaccine contains 20 ppm Tween 80, 0.5% albumin (Human) and less than 1 ppm of bovine serum. Trace amounts of polymyxin B and neomycin may be present from the cell growth medium. Ampuls of 0.5 mL. Packages of 5. Store between 2 and 8°C. Do not freeze. Product that has been exposed to freezing should not be used. Do not use vaccine after expiration date.

Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) – IPV Connaught Poliomyelitis Prophylaxis

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