Intranasal AD4-H5-VTN as an Adenovirus Vaccine

Summary

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.

Timeline

Start

2013-03-06

Primary completion

2018-01-09

Completion

2019-04-22

Publications

• Background Connors M, Collins PL, Firestone CY, Sotnikov AV, Waitze A, Davis AR, Hung PP, Chanock RM, Murphy BR. Cotton rats previously immunized with a chimeric RSV FG glycoprotein develop enhanced pulmonary pathology when infected with RSV, a phenomenon not encountered following immunization with vaccinia--RSV recombinants or RSV. Vaccine. 1992;10(7):475-84. doi: 10.1016/0264-410x(92)90397-3.
• Background Couch RB, Cate TR, Fleet WF, Gerone PJ, Knight V. Aerosol-induced adenoviral illness resembling the naturally occurring illness in military recruits. Am Rev Respir Dis. 1966 Apr;93(4):529-35. doi: 10.1164/arrd.1966.93.4.529. No abstract available.
• Background Edmondson WP, Purcell RH, Gundelfinger BF, Love JW, Ludwig W, Chanock RM. Immunization by selective infection with type 4 adenovirus grown in human diploid tissue culture. II. specific protective effect against epidemic disease. JAMA. 1966 Feb 7;195(6):453-9. No abstract available.
• Matsuda K, Migueles SA, Huang J, Bolkhovitinov L, Stuccio S, Griesman T, Pullano AA, Kang BH, Ishida E, Zimmerman M, Kashyap N, Martins KM, Stadlbauer D, Pederson J, Patamawenu A, Wright N, Shofner T, Evans S, Liang CJ, Candia J, Biancotto A, Fantoni G, Poole A, Smith J, Alexander J, Gurwith M, Krammer F, Connors M. A replication-competent adenovirus-vectored influenza vaccine induces durable systemic and mucosal immunity. J Clin Invest. 2021 Mar 1;131(5):e140794. doi: 10.1172/JCI140794.

Drugs

Indications

No indication recorded.