Intranasal AD4-H5-VTN as an Adenovirus Vaccine

Exclusion Criteria

• •A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
• •1\. Any condition that, in the investigator s judgement, places the subject at undue risk by participating in the study.
• •The following exclusion criterion applies to vaccines and intimate contact, but not to household contacts:
• •1. History of any prior disease or therapy which would affect immune or pulmonary function.
• •2. Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• •3. History of radiation therapy or cytotoxic/cancer chemotherapy.
• •4. History of diabetes mellitus.
• •5. Immunodeficiency or autoimmune disease.
• •6. Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency.
• •7. Taking any medication which may affect immune function, except participants may be taking low doses of nonprescription strength NSAIDS (including e.g. ibuprofen or aspirin) or acetaminophen.
• •8. Chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, defer immunization but do not exclude the participant.
• •9. Active Hepatitis B or C infection (i.e. Hepatitis B or C positive serology with the presence of virus antigen or DNA. Ongoing viral replication will be confirmed by a Hepatitis B antigen or Hepatitis C viral load).
• •10. Female of child-bearing potential who is breast-feeding or planning pregnancy during the 28 days following vaccination.
• •1. Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine, protocol adherence, or a participant s ability to give informed consent.
• •2. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to
• •enrollment.
• •3. Participants that live in the same house or apartment with any of the following will be excluded:
• •1. An individual under 18 years of age
• •2. An immunocompromised or immunosuppressed individual
• •3. An individual with chronic respiratory disease
• •4. A woman who is currently pregnant or planning a pregnancy during the period of immunization
• •4. Healthcare worker who has direct contact with immunodeficient, unstable patients, or pediatric patients.
• •5. Participants caring for children less than 36 months of age.
• •6. Receipt of any of the following:
• •* Antiviral medications within 30 days prior to vaccination
• •* Blood products within 120 days prior to HIV screening
• •* Immunoglobulin within 60 days prior to HIV screening
• •* Investigational research drugs or any other investigational agent that in the judgement of the PI might interact with the study vaccine within 30 days prior to initial study vaccine administration
• •* Allergy treatment with antigen injections within 30 days of study vaccine administration
• •7. History of Guillain-Barr(SqrRoot)(Copyright) syndrome.
• •8. History of H5 influenza vaccination. (This criterion does not apply to participants in vaccine arm B.)
• •1. History of systemic hypersensitivity reactions to egg proteins or life-threatening reactions to previous influenza vaccinations.
• •2. History of Guillain-Barr(SqrRoot)(Copyright) syndrome.
• •3. Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency.
• •4. Taking any medication which may affect immune function, except participants may be taking low doses of nonprescription strength NSAIDS (including e.g. ibuprofen or aspirin) or acetaminophen.
• •5. Receipt of an approved vaccine, investigational research drugs, or any other investigational agent that in the judgement of the PI might interact with the study vaccine within 30 days prior to H5N1 vaccine administration.
• •6. Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of the H5N1 vaccine, protocol adherence, or a participant s ability to give informed consent.