Adenovirus Type 4 and Type 7 Vaccine Live Oral

Name: Adenovirus Type 4 and Type 7 Vaccine Live Oral

Uses for Adenovirus Type 4 and Type 7 Vaccine Live Oral

Prevention of Adenovirus Respiratory Disease

Prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7.1 4 5 6 8 Labeled by FDA for use in military populations 17 through 50 years of age;1 not commercially available for use in other individuals.14 (See Restricted Distribution under Dosage and Administration.)

Adenoviruses, especially adenovirus type 4 and type 7, commonly cause acute respiratory disease (e.g., runny nose, fever, sore throat, breathing problems, cough, headache, croup, bronchitis).5 6 9 12 105 Certain adenovirus serotypes cause other illnesses (e.g., conjunctivitis, keratoconjunctivitis, otitis media, gastroenteritis, cystitis).6 9 105 Disseminated or life-threatening infections can occur (e.g., severe pneumonia, hepatitis, meningitis, encephalitis).105 Adenoviruses spread person to person via direct contact, respiratory droplet transmission, or food and/or water contaminated with feces.5 6 9 105 Fomites also may be involved in transmission since adenoviruses survive for long periods outside of the body, including on environmental surfaces, and are unusually stable when exposed to chemical and physical agents or adverse pH conditions.5 6 9 105

Military recruits are at increased risk of acute respiratory illnesses during basic training because of several factors, including close sleeping and training environments where transmission of respiratory pathogens is facilitated, congregation of young adults arriving from wide geographic distributions who may enter basic training carrying pathogens capable of being spread to others who are immunologically susceptible, and stressful nature of basic training and military operations.2 3 5 12 13 Adenoviruses, especially adenovirus type 4 and type 7, are a well documented cause of acute respiratory illness in military recruits;2 3 4 5 12 13 adenoviruses reportedly cause 50–80% of cases of acute respiratory disease in this population.3 12 Outbreaks of adenovirus-associated disease also occur in other populations (e.g., healthcare-associated outbreaks),3 9 105 but the combination of sustained transmission and relatively high and predictable attack rates of adenovirus-associated respiratory disease appears to be unique to military basic trainees.3

US Department of Defense (DOD) requires that all enlisted US military recruits 17 through 50 years of age receive a single dose of adenovirus type 4 and type 7 vaccine live oral at the earliest opportunity upon arrival at initial entry training (basic military training), unless contraindicated (see Contraindications under Cautions).4 5 6 8 May also be recommended for other military personnel at high risk for adenovirus infection,10 but not required for cadre working at enlisted basic training sites.4

Cautions for Adenovirus Type 4 and Type 7 Vaccine Live Oral

Contraindications

  • Pregnancy.1 (See Pregnancy under Cautions.)

  • History of severe allergic reaction (e.g., anaphylaxis) to any vaccine component.1

  • Inability to swallow tablets whole without chewing.1 (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.1 Not known whether adenovirus vaccine can cause fetal harm.1 (See Pregnancy under Cautions.)

Contraindicated in pregnant women;1 avoid pregnancy for at least 6 weeks after vaccination.1

Because vaccinees shed live vaccine virus1 for up to 28 days after vaccination14 and because of possibility of fetal harm if a pregnant woman is exposed to adenovirus, advise vaccine recipients to use caution for 28 days after vaccination if in close contact with a pregnant woman.1 4 5 6

Individuals with Altered Immunocompetence

Safety and efficacy not established in immunocompromised individuals.1

US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that individuals with altered immunocompetence generally should not receive live vaccines since these individuals may be at increased risk for adverse reactions to such vaccines and may have diminished or suboptimal immune responses to vaccines.134 These experts state that use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.134 (See Immunosuppressive Agents under Interactions.)

US Army Military Vaccine Agency (MILVAX) states that adenovirus vaccine is not contraindicated in HIV-infected individuals and routine screening for HIV prior to administration of the vaccine is unnecessary.5

Transmission of Vaccine Virus

Adenovirus vaccine contains live adenovirus;1 vaccine virus is shed in the stool of vaccine recipients and can be transmitted to and cause disease in close contacts.1

Fecal shedding has been detected as early as day 7 after vaccination1 and may last for up to 28 days after vaccination.14 In one study, 27 or 60% of vaccinees shed adenovirus type 4 or type 7 vaccine virus, respectively, in their stools;1 vaccine virus not detected in feces of any of these individuals by 28 days after vaccination and not detected in throat of any vaccinated individuals.1

Caution is advised for 28 days after vaccination if vaccinee is in close contact with children <7 years of age, immunocompromised individuals, or pregnant women (see Fetal/Neonatal Morbidity and Mortality under Cautions).1 5 6

To minimize potential transmission of vaccine virus, vaccinees should use hygienic measures (e.g., frequent hand washing, especially after bowel movements) for 28 days after vaccination.1 5

Risk of Transmissible Agents in Plasma-derived Preparations

Adenovirus vaccine contains albumin human.1 Since albumin human is prepared from human blood, it is a potential vehicle for transmission of human viruses and there is a theoretical risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD).1 Improved donor screening practices and viral elimination/inactivation procedures have resulted in plasma-derived preparations with greatly reduced risk for transmission of viruses.1 No cases of transmission of viruses or CJD have been identified for plasma-derived albumin human.1

Concomitant Illness

Defer vaccination in individuals with vomiting and/or diarrhea;1 4 5 6 effectiveness of the vaccine depends on replication of live vaccine virus in the intestines.1 4 5 6

ACIP states defer vaccination in individuals with a moderate or severe acute illness (with or without fever) until they have recovered to avoid superimposing adverse effects of the vaccine on the underlying illness or to avoid mistakenly concluding that a manifestation of the underlying illness resulted from vaccination.134

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against adenovirus infection;1 3 will not provide protection against other serotypes not represented in the vaccine (e.g., adenovirus types 3, C, 14, 21).1 3

Duration of Immunity

Duration of protection not determined;5 revaccination or additional doses not recommended.4 5

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 (See Storage under Stability.)

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.134 If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

Contraindicated in pregnant women;1 avoid pregnancy for at least 6 weeks after vaccination.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

There were 5 pregnancies reported among women enrolled in a clinical study evaluating the vaccine in US military recruits ≥17 years of age.1 Four of these women (3 vaccine recipients and 1 placebo recipient) were estimated to have conceived 2–13 days prior to vaccination;1 the other woman (vaccine recipient) conceived approximately 21 weeks after vaccination.1 All 5 women delivered healthy infants with estimated gestational ages of 36–40 weeks.1

Data not available regarding effect of the vaccine on labor and delivery.1 Vaccine virus shed in stools during delivery may result in transmission of vaccine virus to the neonate.1

Lactation

Not known whether adenovirus vaccine distributed into human milk.1

Manufacturer states use with caution in nursing women;1 some experts state do not use in nursing women.4 10

Pediatric Use

Safety and efficacy not established in infants and children <17 years of age.1

Adults 51 through 64 Years of Age

Not indicated in adults 51 through 64 years of age.1

Geriatric Use

Safety and efficacy not established in adults ≥65 years of age.1

Clinical studies did not include individuals ≥65 years of age;1 data not available to determine whether geriatric individuals respond differently than younger adults.1

Common Adverse Effects

Upper respiratory tract infection, headache, nasal congestion, pharyngolaryngeal pain (sore throat), cough, arthralgia, GI effects (abdominal pain, nausea, diarrhea, vomiting).1

Advice to Patients

  • Prior to administration of adenovirus type 4 and type 7 vaccine live oral, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient. (VIS available at .)10

  • Advise patient of the risks and benefits of the vaccine.1 10

  • Advise patient that adenovirus type 4 and type 7 vaccine may not protect all vaccine recipients against adenovirus infection.1 The vaccine will not provide protection against disease caused by adenovirus serotypes not represented in the vaccine.1

  • Importance of taking the vaccine as directed.1 Advise patient to swallow the vaccine tablets whole with a small amount of water and without chewing or crushing them.1 7 Importance of informing clinician if not able to swallow tablets whole without chewing them.1 Advise patients to inform clinician if they accidentally chew a vaccine tablet.1

  • Advise patient that adenovirus type 4 and type 7 vaccine is a live virus vaccine and that vaccine virus is shed in the stool1 14 for up to 28 days following vaccination14 and can be transmitted to and cause disease in close contacts during this period.1 To minimize risk of transmission of vaccine virus, advise patients to take precautions (i.e., frequent hand washing, especially after bowel movements) for 28 days after vaccination if in close contact with children younger than 7 years, immunocompromised individuals, or pregnant women.1 (See Transmission of Vaccine Virus under Cautions.)

  • Importance of informing clinician if any adverse reactions occur following vaccination, including hypersensitivity reactions (e.g., difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, fast heartbeat, dizziness), symptoms of respiratory infection (e.g., runny nose, fever, cough, sore throat), or severe stomach pain or diarrhea.10 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or .10

  • Importance of informing clinician of any history of severe or life-threatening allergies, including a history of allergic reactions to any ingredient in the vaccine.1 10

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any current illnesses (i.e., vomiting and/or diarrhea, weakened immune system).1 134 Importance of notifying clinician if receiving treatment that may weaken the immune system (e.g., high-dose corticosteroids, cancer chemotherapy).1 134

  • Importance of women informing clinician if they are or plan to become pregnant or are breast-feeding.1 Advise women to avoid pregnancy for at least 6 weeks following vaccination.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of adenovirus type 4 and type 7 vaccine live oral is restricted.14 (See Restricted Distribution under Dosage and Administration.)

Adenovirus Type 4 and Type 7 Vaccine Live Oral

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, enteric coated

≥4.5 log10TCID50 of adenovirus type 4 per tablet or ≥4.5 log10TCID50 of adenovirus type 7 per tablet

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (copackaged in separate bottles)

Teva

For Healthcare Professionals

Applies to adenovirus vaccine: oral tablet

General

The most common adverse events were upper respiratory tract infections, headache, nasal congestion, pharyngolaryngeal pain, cough, arthralgia, nausea, abdominal pain, diarrhea, and vomiting.[Ref]

Respiratory

Very common (10% or more): Nasal congestion (15.3%), pharyngolaryngeal pain (12.9%), cough (12.4%)
Common (1% to 10%): Rhinorrhea[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain upper (14.6%), nausea (13.6%), diarrhea (10.2%)
Rare (less than 0.1%): Gastroenteritis, febrile gastroenteritis, gastritis, hematochezia[Ref]

Other

Very common (10% or more): Upper respiratory tract infection (37.5%)
Common (1% to 10%): Pyrexia (temperature of 100.5F or higher), pain in extremity[Ref]

Nervous system

Very common (10% or more): Headache (29.5%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (17.3%)
Common (1% to 10%): Chills[Ref]

Immunologic

Rare (less than 0.1%): Pneumonia, appendicitis[Ref]

Genitourinary

Rare (less than 0.1%): Hematuria[Ref]

Some side effects of adenovirus vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Adenovirus vaccine Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Many viruses are excreted in human milk. -The potential for disease in the infant from exposure is unknown. -Live, non-attenuated viruses are shed in the stool over 28 days. -Consider avoiding the vaccine during breastfeeding, and avoiding breastfeeding for at least 28 days after vaccination.

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