Adenovirus Type 4 and Type 7 Vaccine Live Oral

Name: Adenovirus Type 4 and Type 7 Vaccine Live Oral

Introduction

Live virus vaccine.1 Available in US as adenovirus type 4 and type 7 vaccine live oral containing viable, selected strains of human adenovirus type 4 and type 7 prepared in human diploid fibroblast cell cultures.1 Used to stimulate active immunity to the adenovirus serotypes represented in the vaccine.1

Adenovirus Type 4 and Type 7 Vaccine Live Oral Dosage and Administration

General

Restricted Distribution

Developed specifically for use in military populations.4 Labeled by FDA for use in military populations 17 through 50 years of age;1 not available for use in other populations.14

Administration

Oral Administration

Administer orally as 2 separate tablets:1 one tablet containing adenovirus type 4 vaccine component and one tablet containing adenovirus type 7 vaccine component.1

Tablets contain live adenovirus inside an enteric coating;1 designed to pass through stomach intact and release live vaccine virus in the intestine.1 Swallow tablets whole; do not chew or crush.1 7 If tablets are chewed, adenovirus will be released too soon and could expose the upper respiratory tract to live vaccine virus and result in adenovirus disease.1 7

To facilitate swallowing of vaccine tablets and reduce risk of inadvertent chewing, ingest the tablets with a small amount of water.7 Both vaccine tablets may be swallowed at the same time or swallowed separately, one after the other, whichever is easier to accomplish without chewing.7

If vaccine tablets are accidentally chewed, clear the vaccine from the mouth by swishing and swallowing several sips of water, followed by swishing antiseptic mouthwash for 30 seconds and then spitting the used mouthwash into a container.7 Consider the used mouthwash biohazardous material and handle and dispose of according to local guidelines.7 Advise individuals who inadvertently chew tablets to seek medical care if they develop symptoms of fever or respiratory infection and to inform their clinician about the chewed tablets.7

Defer administration of vaccine tablets in individuals with vomiting and/or diarrhea.1 4 5 (See Concomitant Illness under Cautions.)

May be given simultaneously with or at any interval before or after other vaccines.5 134 (See Vaccines under Interactions.)

Dosage

Adults

Prevention of Adenovirus Respiratory Disease Military Personnel 17 through 50 Years of Age Oral

Administer as a single dose consisting of one tablet of adenovirus type 4 component and one tablet of adenovirus type 7 component.1 (See Preparations for description of tablet contents.)

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

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

Not indicated in adults >50 years of age, including geriatric adults.1

Interactions for Adenovirus Type 4 and Type 7 Vaccine Live Oral

Vaccines

Specific studies not available evaluating whether concurrent administration with other vaccines affects immunologic responses or adverse effects.1 May be administered simultaneously with or at any interval before or after other vaccines, including other live virus vaccines.4 5 134

Has been 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.1

Specific Drugs

Drug

Interaction

Comments

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for diminished or suboptimal antibody response to vaccines134

Live viral vaccines generally contraindicated in those receiving high dosages of systemic corticosteroids or when immunosuppression occurs with prolonged topical corticosteroid therapy134

Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine not determined;134 generally defer live viral vaccines for at least 3 months after immunosuppressive therapy discontinued, including chemotherapy or radiation for leukemia, other hematopoietic malignancies, or solid tumors, or after solid organ transplant134

Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;134 delay administration of live viral vaccines for at least 1 month after such therapy discontinued134

Corticosteroid therapy involving short-term (<2 weeks), low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); inhalation; or intra-articular, bursal, or tendon injections generally does not contraindicate use of live viral vaccines134

Stability

Storage

Oral

Tablets

2–8°C.1 Do not freeze.1

Provided in 2 separate multiple-dose bottles that are copackaged; each bottle contains tablets of only 1 of the 2 individual vaccine components.1 Vaccine tablets must be protected from moisture;1 keep bottles tightly closed and do not remove desiccant.1

For the Consumer

Applies to adenovirus vaccine: oral tablets

Side effects include:

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

Adenovirus vaccine Pregnancy Warnings

Use is contraindicated. US FDA pregnancy category: Not assigned Comments: -Pregnancy should be avoided for 6 weeks after administration of this vaccine.

Animal studies have not been conducted. There are no controlled data in human pregnancy. Three vaccine recipients delivered healthy infants, however naturally occurring adenovirus infections are associated with fetal harm. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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