Questions & Answers
Adenovirus - Adenovirus Types 4 and 7 Vaccine
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Questions
Answers

Immunization

  1. Is there an FDA licensed vaccine for adenovirus?
    Yes. The FDA licensed the adenovirus vaccine on 16 March 2011 for types 4 and 7 for military populations, 17 to 50 years of age.

  2. Who should get adenovirus vaccine?
    The current DoD policy requires the Services to administer adenovirus vaccine to all enlisted military recruits in accordance with Immunizations and Chemoprophylaxis for the Prevention of Infectious Diseases (Joint Publication).

  3. What side effects have been reported with the adenovirus vaccine?
    A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine causing serious harm, or death, is extremely small. Several mild problems were reported within 2 weeks of getting the vaccine: headache, upper respiratory tract infection (about 1 person in 3), stuffy nose, sore throat, joint pain (about 1 person in 6), abdominal pain, cough, nausea (about 1 person in 7), diarrhea (about 1 person in 10), and fever (about 1 person in 100). More serious problems have been reported by about 1 person in 100, within 6 months of vaccination. These problems included: blood in the urine or stool, pneumonia, and inflammation of the stomach or intestines. It is not clear whether these common or serious adverse events were caused by the vaccine or occurred after vaccination by chance.

  4. How effective is the adenovirus vaccine?

    Large-scale studies of the new vaccine in U.S. military recruits showed high efficacy rates in preventing wild type 4 adenovirus-associated febrile acute respiratory disease and inducing neutralizing antibody to type 7 adenovirus.



  5. What are the components of the adenovirus vaccine?

    The adenovirus vaccine contains viable, selected strains of human adenovirus Type 4 and human adenovirus Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38). The virus strains have not been attenuated. The cells are grown and the virus growth maintained in Dulbecco's Modified Eagle's Medium, fetal bovine serum, and sodium bicarbonate.



Administration

  1. How is this vaccine given?
    Adenovirus vaccine types 4 and 7 are tablets and are given orally. Each tablet must be swallowed whole and cannot be chewed or crushed. Postpone administration to individuals with vomiting and/or diarrhea and those with moderate to severe acute illness.

  2. How many doses of adenovirus vaccine are needed?
    A single dose is needed, which consists of two live, oral enteric-coated tablets (type 4 - white tablet, type 7- light peach tablet). Adenovirus vaccine types 4 and 7 is administered only once and no booster dose is required.

  3. Can the adenovirus vaccine be administered with other vaccines, including live vaccines?
    Adenoviruses vaccine types 4 and 7 can be administered simultaneously or at any interval before or after other vaccines, including live vaccines.

  4. How is the vaccine stored?
    The vaccine must be refrigerated between 2° and 8°C (35° and 46° F) and never frozen. All bottles must be protected from moisture and remain tightly closed. The desiccant canister should not be removed from the bottle.

  5. How long does protective immunity of adenovirus vaccine types 4 and 7 last?
    The duration of immunity and persistence of circulating antibody following immunization has not yet been determined. The vaccine is very effective in reducing disease.

Contraindications

  1. Who should NOT receive this vaccine?
    Individuals with known severe allergic reactions to any components of the vaccine; females considering pregnancy within 6 weeks of receiving the vaccine; individuals incapable of swallowing an entire tablet, whole, without chewing should not receive the vaccine.

  2. Are there any warnings or precautions associated with the vaccine?
    Yes. Vaccinees should use precaution when around children 7 years of age and younger, immunocomprised individuals and pregnant women during the 28 days following vaccination. Because the vaccine contains live adenovirus that is shed in the stool for up to 28 days following vaccination, strict hand washing and personal hygiene is required to minimize risk of transmitting or infecting others with the virus.

  3. Is pregnancy a contraindication for the adenovirus vaccine?
    Yes. The adenovirus vaccine should not be administered to pregnant females or nursing mothers.

  4. Is pregnancy testing necessary before administration of the adenovirus vaccine?
    Pregnancy testing is part of a routine serology panel for newly enlisted female recruits upon accession because pregnancy is a disqualifying condition for basic training. Do not delay vaccination pending routine recruit pregnancy testing unless pregnancy is suspected. If a female recruit has a positive HCG do not administer live vaccines including adenovirus vaccine and refer the female for follow-up per Service policy. Verbal screening for pregnancy in non-recruit populations is standard practice before administering of live vaccines.

  5. Is HIV a contraindication for the adenovirus vaccine?
    No. However, the safety and effectiveness of the Adenovirus Types 4 and 7 Vaccine, Live, Oral in immunocompromised individuals has not been evaluated. A documented negative HIV test is not required before administering live vaccines when the vaccinee is screened for immunocompromising conditions. Verbally screen individuals for HIV/AIDS, medical conditions, and/or medications that may affect the immune system before administering the adenovirus vaccine.