Adenovirus Type 4 (adenovirus vaccine live type-4)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Adenovirus vaccine is used to stimulate active immunity to the adenovirus serotypes represented in the vaccine.
Adenovirus vaccine contains live, unattenuated strains of human adenovirus type 4 and human adenovirus type 7 and is used to stimulate active immunity to the adenovirus serotypes represented in the vaccine.
Adenovirus vaccine is provided by the manufacturer as 2 separate enteric-coated tablets to be taken together: one tablet contains the adenovirus type 4 vaccine component and one tablet contains the adenovirus type 7 vaccine component. Following oral administration, the enteric-coated tablets pass through the stomach intact. The live adenoviruses are then released in the intestines where they replicate and induce active immunity in individuals with low or no preexisting neutralizing antibodies to these adenovirus serotypes.
Following a single dose of adenovirus vaccine in US military recruits 17 years of age and older, the adenovirus type 4 and type 7 seroconversion rates were 94.5 and 93.8%, respectively. Live vaccine virus is shed in the stools of individuals who receive adenovirus vaccine; fecal shedding can last for up to 28 days after vaccination. In one study, 27 or 60% of vaccinees shed adenovirus type 4 or type 7 vaccine virus, respectively, in their stools.
Adenovirus vaccine is prepared in human diploid fibroblast cell cultures (strain WI-38). The cells are grown and virus growth maintained in Dulbecco's Modified Eagle's Medium, fetal bovine serum, and sodium bicarbonate. The virus is harvested, freed of particulate cellular material by filtration, and then formulated and dried by lyophilization.
The dried virus material includes monosodium glutamate, sucrose, d-mannose, d-fructose, dextrose, human serum albumin, potassium phosphate, and Plasdone(R) C. Each enteric-coated tablet of adenovirus type 4 and each enteric-coated tablet of adenovirus type 7 contains an inner core tablet containing anhydrous lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate, and the live adenovirus at a potency of not less than 32,000 tissue-culture infective doses (4.5 log10 TCID50) per tablet. The outer tablet layer contains microcrystalline cellulose, magnesium stearate, and anhydrous lactose, with an enteric coating consisting of cellulose acetate phthalate, alcohol, acetone, and castor oil; the adenovirus type 7 tablet also contains FDC yellow #6 aluminum lake dye to differentiate it from the adenovirus type 4 tablet.
Generic name: adenovirus vaccine live type-4
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Adenovirus Type 4
Indications
The following indications are listed for Adenovirus Type 4:
- Adenovirus Types 4, 7 Vaccination
Also known as: Active Immunization Against Adenovirus Types 4, 7, Prophylaxis For Adenovirus Types 4, 7 Infection, Vaccination For Prevention Of Adenovirus Types 4, 7 Infection.
Dosing
No dosing information is available for this tab.
Adenovirus vaccine is administered orally as 2 separate tablets. One tablet contains the adenovirus type 4 vaccine component and one tablet contains the adenovirus type 7 vaccine component.
Adenovirus vaccine tablets contain live adenovirus inside an enteric coating. The tablets are designed so that they pass through the stomach intact and release live vaccine virus in the intestines. The tablets should be swallowed whole and should not be chewed or crushed. If the tablets are chewed, the adenovirus will be released too soon and could expose the upper respiratory tract to live vaccine virus and result in adenovirus disease.
Store adenovirus vaccine under refrigeration between 2-8degreesC; do not freeze. Keep the bottle tightly closed to protect from moisture and do not remove the desiccant canister from the bottle.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Pregnancy.
*History of severe allergic reaction (e.g., anaphylaxis) to any vaccine component.
*Inability to swallow tablets whole without chewing.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 5% or more of adults 17 through 50 years of age who received adenovirus vaccine include upper respiratory tract infection, headache, nasal congestion, pharyngolaryngeal pain (sore throat), cough, arthralgia, and GI effects (abdominal pain, nausea, diarrhea, vomiting).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of adenovirus vaccine have not been established in infants and children younger than 17 years of age.
Adenovirus vaccine is contraindicated in pregnant women, and pregnancy should be avoided by using effective contraception for at least 6 weeks after vaccination. Females of reproductive potential should receive a pregnancy test prior to receipt of the vaccine.
Naturally occurring adenovirus infection has been associated with fetal harm. It is not known whether adenovirus vaccine can cause fetal harm when administered to a pregnant woman or affect reproduction capacity.
There were 5 pregnancies reported among women enrolled in a clinical study that evaluated use of adenovirus vaccine in US military recruits 17 years of age and older. Four of these women (3 vaccine recipients and 1 placebo recipient) were estimated to have conceived 2-13 days prior to vaccination; the other woman (vaccine recipient) conceived approximately 21 weeks after vaccination. All 5 women delivered healthy infants with estimated gestational ages of 36-40 weeks.
Data are not available regarding the effect of adenovirus vaccine on labor and delivery. Vaccine virus shed in stools during delivery may result in transmission of the vaccine virus to the neonate.
There are no data on the presence of adenovirus vaccine in human milk, effects on milk production, or on the breastfed infant following administration.
Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the vaccine and any potential adverse effects on the breast-fed infant from the vaccine or from the underlying maternal condition.
Adenovirus vaccine is not indicated in adults older than 50 years of age, including geriatric adults.
Safety and efficacy of adenovirus vaccine have not been established in adults 65 years of age or older.
Clinical studies evaluating adenovirus vaccine did not include individuals 65 years of age or older, and data are not available to determine whether geriatric individuals respond differently than younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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