Intranasal AD4-H5-VTN as an Adenovirus Vaccine

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

Background: * Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These viruses are being tested as part of a possible new vaccine. Researchers hope that the adenovirus will help carry the vaccine into the body and cause an immune response. An immune response is the body s release of cells and substances that protect the body from infection. If an adenovirus vaccine can be developed, it might be used as part of a vaccine for malaria or other serious illnesses. Researchers want to test the adenovirus vaccine as a nasal spray in healthy volunteers. The vaccine is called AD4-H5-VTN. * Because the vaccine contains a live adenovirus, there is a possibility that participants can infect other people. Therefore, participants' intimate contacts must join this study. An intimate contact is someone who the participant will kiss on the mouth or have sexual intercourse with during the period of this study. Objectives: * To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers. * To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others. Eligibility: * Healthy volunteers between 18 and 49 years of age. * Intimate contacts of healthy volunteers between 18 and 65 years of age. * Participants must not have evidence of previous exposure to adenovirus type 4. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants who will receive the vaccine must be willing to be hospitalized for between 5 and 7 days. They will come to the National Institutes of Health for follow-up visits weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year. They must also avoid all vaccines (including seasonal flu vaccine) and allergy shots for 30 days before and after having the study vaccine. * Participants will enter the hospital for the vaccine study visit. They will receive the vaccine as a nasal spray. Because the vaccine uses a live virus, participants may be contagious for the virus for up to 4 weeks. They will remain in the hospital in respiratory isolation for 7 days, or until they have two negative nasal washes taken 1 day apart. A negative nasal wash means that there is no live virus in the nose. * After leaving the hospital, participants will keep a diary at home for at least 3 weeks. They will record their temperature, any symptoms, or other health changes every day during this time. * Participants should avoid intimate contact with others for 28 days after having the vaccine. Intimate contact includes kissing on the mouth and sexual intercourse. Also, participants should not share kitchen utensils, drinking cups, towels, or hair combs with others. Intimate contacts will also keep track of any illnesses or symptoms they develop during this time. * At the follow-up visits, participants will provide blood and swab samples for study.

Key facts

Study ID

NCT01806909

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

51

Starts

2013-03-06

Expected to finish

2019-04-22

Last updated by the study team

2019-10-07

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
• 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:
• History of any prior disease or therapy which would affect immune or pulmonary function.
• Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of radiation therapy or cytotoxic/cancer chemotherapy.
• History of diabetes mellitus.
• Immunodeficiency or autoimmune disease.
• Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency.
• 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.
• 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.
• 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).
• Female of child-bearing potential who is breast-feeding or planning pregnancy during the 28 days following vaccination.
• The following exclusion criteria apply only to vaccinees and not to household or intimate contacts:
• 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.
• 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.
• Participants that live in the same house or apartment with any of the following will be excluded:
• An individual under 18 years of age
• An immunocompromised or immunosuppressed individual
• An individual with chronic respiratory disease
• A woman who is currently pregnant or planning a pregnancy during the period of immunization
• Healthcare worker who has direct contact with immunodeficient, unstable patients, or pediatric patients.
• Participants caring for children less than 36 months of age.
• Receipt of any of the following:

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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