Dosing and uses of Adenovirus types 4 and 7 vaccine live (oral)
Adult dosage forms and strengths
tablets, enteric-coated
- Adenovirus type 4≥4.5 log10 TCID50
- Adenovirus tyep 7≥4.5 log10 TCID50
Adenovirus Active Immunization
Indicated for active immunization of military populations for prevention of febrile acute respiratory disease caused by adenovirus types 4 and 7
Aged 17-50 years: Single vaccine dose consists of 2 tablets: 1 tablet of adenovirus type 4 and one tablet of adenovirus type 7
Swallow tablets whole, do not chew, crush, or split; chewing a tablet could expose the upper respiratory tract to live adenovirus leading to disease
Storage
- Refrigerate between 2-8 degrees C (35-46 degrees F); protect from moisture; do not remove desiccant from bottle
Pediatric dosage forms and strengths
<17 years: Safety and efficacy not established
Adenovirus types 4 and 7 vaccine live (oral) adverse (side) effects
Adverse effects were similar to placebo for the first 7 days following vaccination; those listed below were slightly higher than those for placebo
>10%
Nasal congestion (15.3%)
Diarrhea (10.2%)
Headache (7-30%)
Nausea (5-14%)
Cough (10-12%)
1-10%
Pyrexia (1.4%)
Fever (≤1%)
Limb pain (4%)
Rhinorrhea (4%)
<1%
Gastritis
Hematuria
Gastroenteritis
Pneumonia
Hematochezia
Warnings
Contraindications
Hypersensitivity
Pregnancy
Inability to swallow table whole (chewing a tablet could expose the upper respiratory tract to live adenovirus leading to disease)
Cautions
Vomiting or diarrhea could decrease effectiveness of vaccine
Safety has not been evaluated in individuals with altered immunocompetence
Contains live viruses that are shed in the stool and can cause disease if transmitted; those vaccinated should avoid close contact with children younger than 7 years and immunocompromised individuals
Tablets contain human albumin (<0.3 mg/tablet), which could theortetically increase risk transmission of blood borne diseases (e.g., Creuzfeldt-Jakob disease)
Effective immunity may not occur in all vaccinated patients
Pregnancy and lactation
Pregnancy category: X
Unknown whether adenovirus can cause fetal harm; naturally occurring infection with adenoviruses has been associated with fetal harm
Lactation: Unknown whether distributed in breast milk; caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Adenovirus types 4 and 7 vaccine live (oral)
Mechanism of action
Live oral vaccine that replicates in intestinal tract and induces immunity in persons with low or no pre-existing neutralizing antibodies to adenoviruses types 4 and 7
Pharmacokinetics
Duration: Viral shedding not detected after 28 days
Onset: Viral shedding in the stool starts at 7 days; seroconversion starts at 26 days following vaccination
Absorption: Not detected in serum (limited data)
