Adenovirus vaccine

VAERS EXPLORER
RESOURCEGATEWAY
ADENOVIRUS VACCINE
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Adenovirus Type 4 and Type 7Vaccine, Live, Oral
https://www.aretezoe.com/vaers-explorer

 Non-enveloped viruses with double-
stranded DNA.
 Relatively resistant to common
disinfectants.
 More than 50 types of
immunologically distinct
adenoviruses exist.
ADENOVIRUS
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

ADENOVIRUS DISEASE
SYMPTOMS:
 Respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis
 Less common: gastroenteritis, conjunctivitis, cystitis, or neurological disease.
AFFECTED POPULATION:
 Common cause of acute respiratory illness in military recruits.
 People with weakened immune systems are at high risk of developing a severe disease.
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

AdenovirusType 4 andType 7Vaccine, Live,Oral (US)
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

Approval in the UK and Europe
 Not approved in the UK
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 Not approved in the European Union
Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

Vaccine technology
 Contains viable, not attenuated strains of human adenovirus Type 4 and Type 7
 Prepared in human-diploid fibroblast cell cultures (strain WI-38)
 Grown and maintained in Dulbecco’s Modified Eagle’s Medium, fetal bovine serum, and sodium
bicarbonate.
 Lyophilized virus material includes monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose,
human serum albumin, potassium phosphate, and plasdone C.
 The final vaccine is composed of two tablets (one tablet of Adenovirus Type 4 and one tablet of
Adenovirus Type 7) designed to pass intact through the stomach and release the live virus in the
intestine.
 Potency 32,000 tissue-culture infective doses (4.5 log10 TCID50) per tablet.
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

INDICATIONS & USAGE
INDICATIONS
 Active immunization for the
prevention of febrile acute
respiratory disease caused by
Adenovirus Type 4 and Type 7
POPULATION
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral
 Military populations 17 through
50 years of age.

CONTRAINDICATIONS
Do not administer in pregnancy.
 It is not known whether the vaccine can
cause fetal harm or affect reproduction
capacity.
 Naturally occurring infection with
adenoviruses has been associated with
fetal harm.
 Pregnancy should be avoided for 6 weeks
following receipt of vaccine.
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Severe Allergic Reaction.
 Severe allergic reaction (e.g.,
anaphylaxis) to any component of the
vaccine.
Inability to Swallow.
 Chewing a tablet could expose the upper
respiratory tract to live adenovirus
leading to disease
Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

WARNINGS & PRECAUTIONS
Shedding andTransmission
 Shedding occurs during 28-day period following the vaccination.
 Vaccinated persons shed the virus in stool; exposed persons can become
infected and sick
 Avoid close contact with children < 7 years of age, pregnant women,
immunocompromised individuals (HIV infection, cancer), or people on
immunosuppressive therapy
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

WARNINGS & PRECAUTIONS
Altered Immunocompetence
 The safety and effectiveness of the vaccine has not been evaluated in
immunocompromised individuals.
Planning for Pregnancy
 Use effective contraception for 6 weeks after vaccination to avoid pregnancy
Human Serum Albumin
 Remote/theoretical risk for transmission of viral diseases and Creutzfeldt-
Jakob disease (CJD).
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

 Headache
 Nasal congestion
 Upper respiratory tract infection
 Upper abdominal pain
 Sore throat
 Cough
 Nausea
 Diarrhea
 Vomiting
 Chills
 Joint pain
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ADVERSE
REACTIONS
Experience from
clinical trials
Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

 Hypersensitivity reactions (including
anaphylaxis)
 Guillain-Barré syndrome
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

CDC List of Reportable AEs:
 None listed
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ADVERSE
EVENTS
OFSPECIAL
INTEREST
Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

PREGNANCY & BREASTFEEDING
PREGNANCY
Do not administer in pregnancy.
 It is not known whether the vaccine can
cause fetal harm. Naturally occurring
infection with adenoviruses has been
associated with fetal harm.
 Pregnancy should be avoided for 6 weeks
following receipt of vaccine.
 Fecal shedding during delivery may
result in vaccine virus transmission to the
newborn infant.
BREASTFEEDING
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral
• No information on virus shedding in
breast milk
• For preventive vaccines, the underlying
maternal condition is susceptibility to
disease prevented by the vaccine.

OTHER POPULATIONS
 The vaccine was not tested in children
 The vaccine was not tested in the elderly (>65 years of age)
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

VACCINE/DRUG INTERACTIONS
Concomitant administration with other vaccines:
 Data on immune response to the other vaccines not available.
ImmunosuppressiveTherapies:
 No data regarding use with immunosuppressive therapies.
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

COMPLETED
CLINICAL
TRAILS
A Study to Assess the Safety,
Pharmacodynamics, and Immunogenicity of
PXVX0047
 Condition: adenoviral infection
 Vaccine: PXVX0047Vaccine,Teva Ad4/Ad7Vaccine
 Study design: Randomized, parallel assignment
 Phase I
 Participants: 25 healthy volunteers (18 – 35 years)
 Date: 5/2017 – 11/2017
 Completed, no results posted
NCT03160339
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral
https://clinicaltrials.gov/ct2/show/study/NCT03160339

PREGNANCY
REGISTRY
Adenovirus Vaccine Pregnancy
Registry
The primary purpose of the Registry is to collect data
concerning pregnant women exposed to the vaccine,
potential confounding factors, and the outcome of
these pregnancies.
No enrolled patients, no results.
NCT01584037
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral
https://clinicaltrials.gov/ct2/show/study/NCT01584037

MANDATE
 The vaccine is mandatory for all enlisted military recruits (Army
Regulation 40-562).
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

PATIENTCOUNSELING INFORMATION
 The vaccine is contraindicated in pregnant women.
 Avoid becoming pregnant within 6 weeks following vaccination.
 Swallow each tablet whole without chewing.
 Live virus that is shed in the stool for up to 28 days following vaccination
and can cause vulnerable people around the vaccinee to become sick.
 Observe proper personal hygiene.
 Avoid close contact with vulnerable people (children < 7 years of age,
immunocompromised individuals, and pregnant women)
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

RESOURCES
 DailyMed
 NCT03160339
 NCT01584037
 CDC – Adenoviruses
 Health.mil – Adenovirus
 Army Regulation 40-562
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Adenovirus
Type
4
and
Type
7
Vaccine,
Live,
Oral

Adenovirus vaccine

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