Adenovirus vaccine (monograph)

Adenovirus vaccine (monograph)

Adenovirus vaccine (monograph)

introduction

Live virus vaccine. Available in the United States as a live oral adenovirus type 4 and type 7 vaccine containing viable, selected strains of human adenovirus types 4 and type 7 produced in human diploid fibroblast cell cultures. Used to stimulate active immunity against the adenovirus serotypes included in the vaccine.

Uses for Adenovirus Vaccines

Prevention of respiratory diseases caused by adenoviruses

Adenoviruses, particularly adenovirus types 4 and 7, often cause acute respiratory illnesses (e.g., runny nose, fever, sore throat, breathing problems, cough, headache, croup, bronchitis). Certain adenovirus serotypes cause other diseases (e.g., conjunctivitis, keratoconjunctivitis, otitis media, gastroenteritis, cystitis). Disseminated or life-threatening infections may occur (e.g., severe pneumonia, hepatitis, meningitis, encephalitis). Adenoviruses spread from person to person through direct contact, transmission via respiratory droplets, or through fecal contaminated food and/or water. Fomites may also be involved in transmission because adenoviruses survive for long periods outside the body, including on environmental surfaces, and are unusually stable when exposed to chemical and physical influences or adverse pH conditions.

Military recruits are at increased risk of acute respiratory illnesses during basic training due to several factors, including close sleeping and training environments that facilitate the transmission of respiratory pathogens, the accumulation of young adults from wide geographic regions who may begin basic training with pathogens, the transmission to others who are immunologically susceptible, and the exposure to basic training and Military operations. Adenoviruses, particularly adenovirus type 4 and type 7, are a well-documented cause of acute respiratory illness in military recruits; Adenoviruses are reported to cause 50–80% of cases of acute respiratory illness in this population. Outbreaks of adenovirus-associated illnesses also occur in other populations (e.g., health care outbreaks), but the combination of sustained transmission and relatively high and predictable attack rates of adenovirus-associated respiratory illnesses appears to occur only among military cadets in basic training.

The U.S. Department of Defense (DOD) requires that all enlisted U.S. military recruits ages 17 to 50 years receive a single oral dose of live adenovirus type 4 and type 7 vaccine as soon as possible after their arrival at initial military training. unless there is a contraindication (see “Contraindications” under “Warnings”). May also be recommended for other military personnel at high risk of adenovirus infection, but is not required for cadres working at enlisted basic training sites.

Adenovirus vaccine dosage and administration

Generally

Limited distribution

Designed specifically for use in the military population. Labeled by the FDA for use in military personnel ages 17 to 50; not available for use in other populations.

Administration

Oral administration

Administer orally as 2 separate tablets: one tablet containing the adenovirus type 4 vaccine component and one tablet containing the adenovirus type 7 vaccine component.

Tablets contain live adenovirus in an enteric-coated shell; Designed to pass through the stomach intact and release live vaccine viruses in the intestines. Swallow tablets whole; Do not chew or crush. If tablets are chewed, the adenovirus is released too early and could expose the upper respiratory tract to the live vaccine virus and lead to adenovirus illness.

To make the vaccine tablets easier to swallow and reduce the risk of accidental chewing, swallow the tablets with a small amount of water. Both vaccine tablets can be swallowed at the same time or one at a time, whichever is easier to do without chewing.

If vaccine tablets are accidentally chewed, remove the vaccine from the mouth by rinsing and swallowing several sips of water, followed by rinsing antiseptic mouthwash for 30 seconds, and then spitting the used mouthwash into a container. Consider the mouthwash used as a biohazardous material and handle and dispose of it in accordance with local guidelines. Advise people who accidentally chew tablets to seek medical attention if they develop symptoms of fever or respiratory infection and to tell their doctor about the chewed tablets.

Administration of vaccine tablets should be postponed in individuals experiencing vomiting and/or diarrhea. (See “Concomitant Illnesses” under “Precautions.”)

May be administered simultaneously with or at any interval before or after other vaccinations. (See Vaccines under Interactions.)

dosage

Adult

Prevention of respiratory diseases caused by adenoviruses

Military personnel aged 17 to 50

Orally

Administer as a single dose consisting of one tablet of adenovirus type 4 component and one tablet of adenovirus type 7 component. (See “Preparations” for a description of the tablet contents.)

Duration of protection not specified; Revaccinations or additional doses are not recommended.

Special populations

Liver dysfunction

No specific dosage recommendations.

Renal dysfunction

No specific dosage recommendations.

Geriatric patients

Not indicated in adults > 50 years, including geriatric adults.

Adenovirus vaccine precautions

Contraindications

• Pregnancy. (See “Pregnancy” under “Precautions.”)

• History of severe allergic reactions (e.g. anaphylaxis) to any of the vaccine components.

• Inability to swallow tablets whole without chewing them. (See Oral Administration under Dosage and Administration.)

Warnings/Precautions

Fetal/neonatal morbidity and mortality

Natural adenovirus infection during pregnancy has been associated with fetal harm. It is not known whether the adenovirus vaccine can harm the fetus. (See “Pregnancy” under “Precautions.”)

Contraindicated in pregnant women; Avoid pregnancy for at least 6 weeks after vaccination.

Because vaccinated individuals shed live vaccine viruses for up to 28 days after vaccination and there is a risk of fetal harm if a pregnant woman is exposed to adenovirus, we advise vaccinated recipients to exercise caution when in close contact with a pregnant woman for 28 days after vaccination.

People with altered immune competence

Safety and effectiveness have not been established in immunocompromised individuals.

The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that individuals with altered immune competence generally should not receive live vaccines because these individuals may be at increased risk of adverse reactions to such vaccines and may have a reduced or suboptimal immune response to vaccines. These experts state that the use of live vaccines can be considered in patients with leukemia, lymphoma or other malignancies if the disease is in remission and chemotherapy has been stopped at least three months before vaccination. (See Immunosuppressants under “Interactions.”)

The US Army Military Vaccine Agency (MILVAX) states that the adenovirus vaccine is not contraindicated in HIV-infected individuals and routine HIV screening is not required prior to vaccine administration.

Transmission of the vaccine virus

The adenovirus vaccine contains live adenoviruses; The vaccine virus is excreted in the stool of vaccine recipients and can be transmitted to close contacts and cause illness.

Stool excretion was noted as early as the 7th day post-vaccination and may continue for up to 28 days post-vaccination. In one study, 27 and 60% of vaccinees excreted adenovirus type 4 and type 7 vaccine virus in their stool, respectively; The vaccine virus was not detected in the feces of these individuals 28 days after vaccination and was not detected in the throat of any of the vaccinated individuals.

For 28 days after vaccination, caution should be exercised if the vaccinee is in close contact with children under 7 years of age, immunocompromised individuals, or pregnant women (see Fetal/Neonatal Morbidity and Mortality under Precautions).

To minimize possible transmission of the vaccine virus, vaccinees should practice hygiene measures (e.g. frequent hand washing, especially after bowel movements) for 28 days after vaccination.

Risk of transmissible pathogens in plasma-derived preparations

The adenovirus vaccine contains human albumin. Because Albumin Human is made from human blood, it is a potential carrier for the transmission of human viruses and there is a theoretical risk of transmission of the pathogen that causes Creutzfeldt-Jakob disease (CJD). Improved donor screening practices and virus elimination/inactivation procedures have resulted in plasma-derived preparations with a greatly reduced risk of viral transmission. No cases of viral or CJD transmission have been identified for human plasma-derived albumin.

Concomitant disease

Postpone vaccination for anyone experiencing vomiting and/or diarrhea; The effectiveness of the vaccine depends on the replication of the live vaccine virus in the intestine.

ACIP States shall delay vaccination of persons with a moderate or severe acute illness (with or without fever) until they have recovered, to avoid the vaccine masking the underlying illness with adverse effects or erroneously inferring that a manifestation of the underlying illness was due to the vaccination.

Limitations on vaccine effectiveness

May not protect all vaccine recipients from adenovirus infection; does not provide protection against other serotypes not included in the vaccine (e.g. adenovirus types 3, C, 14, 21).

Duration of immunity

Duration of protection not specified; Revaccinations or additional doses are not recommended.

Improper storage and handling

Improper storage or handling of vaccines may reduce the effectiveness of the vaccine and lead to a reduced or inadequate immune response in vaccinated people.

Inspect all vaccines upon delivery and monitor storage to ensure proper temperature is maintained. (See Storage under Stability.)

Do not administer any vaccine that has been mishandled or not stored at the recommended temperature. If there is concern about mishandling, contact the manufacturer or state or local immunization or health authorities for guidance on whether the vaccine is usable.

Specific populations

pregnancy

Contraindicated in pregnant women; Avoid pregnancy for at least 6 weeks after vaccination. (See Fetal/Neonatal Morbidity and Mortality under Precautions.)

There were 5 reported pregnancies in women participating in a clinical trial evaluating the vaccine in U.S. military recruits ≥17 years of age. Four of these women (three vaccinated and one placebo recipient) were estimated to have become pregnant two to 13 days before vaccination. The other woman (vaccination) became pregnant approximately 21 weeks after vaccination. All five women delivered healthy infants with an estimated gestational age of 36–40 weeks.

There are no data on the effect of the vaccine on labor and delivery. Vaccine viruses excreted in the stool during delivery can lead to transmission of the vaccine virus to the newborn.

lactation

It is not known whether the adenovirus vaccine passes into breast milk.

The manufacturer states that it should be used with caution in breastfeeding women. Some experts state that they should not be used in women who are breastfeeding.

Pediatric use

Safety and effectiveness in infants and children under 17 years have not been established.

Adults aged 51 to 64

Not indicated in adults aged 51 to 64 years.

Geriatric use

Safety and effectiveness in adults ≥ 65 years have not been established.

Clinical trials did not include subjects aged ≥65 years; There are no data to determine whether geriatric individuals respond differently than younger adults.

Common side effects

Upper respiratory tract infection, headache, nasal congestion, pharyngolaryngeal pain (sore throat), cough, arthralgia, gastrointestinal effects (abdominal pain, nausea, diarrhea, vomiting).

Interactions with other medications

Vaccinations

There are no specific studies examining whether co-administration with other vaccines affects immunological responses or side effects. May be administered concurrently with or at any interval before or after other vaccines, including other live virus vaccines.

Administered concurrently with other vaccines containing diphtheria, tetanus, pertussis, hepatitis A, hepatitis B, human papillomavirus, influenza, measles, mumps, rubella, meningococcal, poliovirus, varicella, typhoid, or yellow fever antigens.

Specific medications

stability

storage

Orally

Tablets

2-8°C. Do not freeze.

Provided in 2 separate multi-dose bottles packaged together. Each bottle contains tablets with only one of the two individual vaccine components. Vaccine tablets must be protected from moisture; Keep bottles tightly closed and do not remove desiccant.

Actions

• The live oral adenovirus type 4 and type 7 vaccine contains live, unattenuated strains of human adenovirus type 4 and human adenovirus type 7, produced in human diploid fibroblast cell cultures (strain WI-38) and is used to stimulate active immunity against adenovirus type 4 and type 7.

• Provided by the manufacturer as two separate enteric-coated tablets to be taken together: one tablet containing the adenovirus type 4 vaccine component and one tablet containing the adenovirus type 7 vaccine component. After oral administration, the enteric-coated tablets pass through the stomach intact. The live adenoviruses are then released into the intestine, where they multiply and induce active immunity in individuals with low or no pre-existing neutralizing antibodies to adenovirus serotypes.

• After a single dose of the oral live oral vaccine adenovirus type 4 and type 7 in US military recruits ≥ 17 years of age, the effectiveness in preventing febrile acute respiratory illness (ARD) caused by adenovirus type 4 was 99.3% and the seroconversion rate for adenovirus type 4 and type 7 is 94.5% 93.8% and duration of protection, respectively and Persistence of circulating antibodies after a single dose of vaccine not determined.

• Live vaccine viruses are excreted in the stool of vaccinated individuals; Stool excretion may continue for up to 28 days after vaccination. In one study, 27 and 60% of vaccine recipients excreted adenovirus type 4 and type 7 vaccine virus in their stool, respectively.

Advice for patients

• Prior to oral administration of the live adenovirus type 4 and type 7 vaccines, a copy of the appropriate CDC Vaccine Information Statement (VIS) must be provided to the patient. (VIS available at .)

• Inform the patient about the risks and benefits of the vaccine.

• Advise patients that the adenovirus type 4 and type 7 vaccine may not protect all vaccine recipients from adenovirus infection. The vaccine does not provide protection against diseases caused by adenovirus serotypes not present in the vaccine.

• It is important that the vaccine is taken as directed. Instruct the patient to swallow the vaccine tablets whole with a little water without chewing or crushing them. It is important to tell the doctor if the tablets cannot be swallowed whole without chewing. Instruct patients to inform the healthcare provider if they accidentally chew a vaccine tablet.

• Advise patients that the adenovirus type 4 and type 7 vaccine is a live vaccine and that the vaccine virus is excreted in stool for up to 28 days after vaccination, during which time it can spread to close contacts and cause illness in them. To minimize the risk of transmission of the vaccine virus, advise patients to take precautions (e.g., frequent hand washing, especially after bowel movements) for 28 days after vaccination when in close contact with children under 7 years of age, immunocompromised individuals, or pregnant women. (See “Vaccine Virus Transmission” under “Precautions.”)

• It is important to inform the doctor if any side effects occur after vaccination, including hypersensitivity reactions (e.g. difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, fast heartbeat, dizziness), symptoms of a respiratory infection (e.g. runny nose, fever, cough). , sore throat) or severe stomach pain or diarrhea. Physicians or individuals can report any post-vaccination adverse reactions to VAERS at 800-822-7967 or [Web].

• It is important to inform the doctor of any history of severe or life-threatening allergies, including a history of allergic reactions to any of the ingredients in the vaccine.

• It is important to inform the doctor about existing or planned concomitant therapies, including prescription and over-the-counter medications, as well as current illnesses (e.g. vomiting and/or diarrhea, weakened immune system). It is important to notify your doctor if you are receiving any treatment that may weaken the immune system (e.g., high-dose corticosteroids, cancer chemotherapy).

• It is important for women to tell the doctor if they are pregnant or planning to become pregnant or are breastfeeding. Advise women to avoid pregnancy for at least 6 weeks after vaccination. (See Fetal/Neonatal Morbidity and Mortality under Precautions.)

• It is important to inform patients of other important precautionary information. (See Precautions.)

Preparations

Excipients in commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.

For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.

Live oral vaccine against adenoviruses type 4 and type 7

AHFS DI Essentials™. © Copyright 2024, Selected changes May 28, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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