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Product Name: Adenovirus vaccine Commercial Name: Adenovirus Vaccine live oral type 4 Adenovirus Vaccine live oral type 7 Date of Licensure: 1980 (out of production 1995; not available after 1998 [adenovirus 4 vaccine] and 1999 [adenovirus 7 vaccine]). Type of Product: live viral vaccine tablet for oral administration Company of Manufacture: Wyeth (1980-1995) Target microorganism/associated disease: Adenoviruses are DNA viruses that are usually transmitted via respiratory (aggravated by crowding) or ocular (spread via swimming pools, physician offices with inadequate sterilization and handwashing practices) routes. Asymptomatic infection and a prolonged carrier state contribute to spread. Diseases associated with adenoviral infections include respiratory illness (bronchitis or pneumonia), eye infections (conjunctivitis), sore throat, and diarrhea. Complications of adenovirus include acute bacterial ear and lung infections, and death. Reasons for development: Adenovirus is a frequent cause of acute respiratory disease (ARD) and pneumonia, and has caused hospitalizations and deaths among military trainees residing in temperate regions. Adenovirus infections also cause illness among deployed troops and civilians. There is no effective antiviral treatment for adenovirus. During World War II, epidemics of respiratory disease in new recruits disrupted training and greatly increased the burden on medical staff and facilities. Before vaccines were available, adenovirus was consistently isolated in 30-70% of trainees with ARD, and adenoviruses were associated with 90% of the cases of pneumonia among trainees. Role of Department of Defense in product development: A commission on ARD was established at FT Bragg, NC from 1942 to 1945 to undertake epidemiologic studies. The viral nature of these infections was established when bacteria-free filtrates were shown to transmit the infection to volunteers. In the 1950s, Hilleman and Werner at the Walter Reed Army Institute of Research (WRAIR) identified adenovirus types 4 and 7, and established the importance of neutralizing antibody as a marker of immunity for these infections. In prospective studies of ARD in recruits, Hilleman and his co-workers established that 20% of recruits were hospitalized with febrile ARD, another 20% sought evaluation at an outpatient facility, 40% had mild or inapparent infections, and the remaining 20% (probably immune) were not infected. In a subsequent similar study of an ARD outbreak at Fort Dix in the 1960s, Buescher and his co-workers observed that 18 (37%) of 48 were hospitalized, and an additional 23 (48%) of 48 were a lso infected with afebrile to mild febrile infections. Formalin-inactivated type 4 and 7 FDA-approved vaccines created in the 1950s were eventually withdrawn because of low potency and contamination with the oncogenic virus SV-40. Chanock and co-workers at the National Institutes of Health prepared a live oral vaccine against adenovirus type 4. Because ARD epidemics caused by adenovirus type 7 continued, Top and co-workers at WRAIR developed a similar safe, highly antigenic live oral adenovirus type 7 vaccine. After extensive testing, these vaccines were approved for distribution by Wyeth Laboratories in 1980. The Wyeth adenovirus vaccines were highly effective in preventing ARD in recruits until 1995, at which time Wyeth ceased production of the adenovirus vaccine when faced with the requirement for a costly update of vaccine manufacturing facilities. To obtain data on the potency of the Wyeth Laboratories live adenovirus types 4 and 7 vaccines (in anticipation of the need to create a new vaccine candidate following cessation of production of the Wyeth product), a trial was conducted at WRAIR by Kuschner and co-workers in 40 male and female volunteers. The Wyeth adenovirus vaccines were noted to be safe and highly immunogenic, as more than 90% of susceptible volunteers developed neutralizing antibody. Currently the DoD is collaborating with Barr Laboratories to develop a replacement live adenovirus vaccine embedded in a pellet within an enteric-coated tablet. |
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