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What is Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age.
The adenovirus vaccine is a live, oral vaccine used to help prevent febrile acute respiratory disease (ARD) caused by adenovirus type 4 and type 7.
Approval was based on the results of a placebo controlled safety and efficacy trial conducted in US military recruits.
Data from this trial found seroconversion rates for adenovirus type 4 and type 7 to be 94.5% and 93.8%, respectively, for vaccine recipients at day 26 post-vaccination; seroconversion rates for those receiving placebo were 10.6% for type 4 and 5.3% for type 7.
No cases of type 7 adenovirus-associated ARD were identified in either the vaccine or placebo group; however, the vaccine group experienced significantly fewer cases of type 4 ARD as compared to those receiving placebo (n = 1 vs. 48, respectively).
The adenovirus vaccine was approved by the FDA for use in military populations ages 17 through 50 years in March 2011.
Indications
Active immunization for the prevention of febrile acute respiratory disease which is caused by Adenovirus Type 4 and Type 7.
- adenovirus
- adenovirus infection prophylaxis
Side Effects
- Headache
- Nasal Congestion (Stuffy Nose)
- Cough
- Sore Throat
- Diarrhea
- Nausea
- Arthralgia
- Upper Abdominal Pain
- Chills
- hematuria
- gastroenteritis
- pneumonia
- appendicitis
- fever
- joint pains
- pain in the extremities
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- chemotherapy
- children
- contraception requirements
- corticosteroid therapy
- diarrhea
- human immunodeficiency virus (HIV) infection
- immunosuppression
- infants
- neonates
- pregnancy
- radiation therapy
- viral infection
- vomiting
Interactions
No information is available regarding drug interactions associated with Adenovirus vaccine
Mechanism of Action
Adenovirus vaccine stimulates the immune system to produce antibodies against adenovirus types 4 and 7.
The vaccine is administered orally, and is designed for the intact tablets to pass through the stomach and release live, NON-attenuated virus strains into the intestine.
Once in the intestinal tract, the virus replicates and induces immunity in persons with low or no pre-existing neutralizing antibodies.
Within 7 days, and up to day 28, vaccine virus strains are shed in the stool of those receiving the vaccine.
Pharmacokinetics
Adenovirus vaccine is administered orally. Pharmacokinetic data are not available from the manufacturer