A phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of the live, oral adenovirus type 4 and type 7 vaccine, in U.S. military recruits

Kuschner, Robert A.; Russell, Kevin L.; Abuja, Mary; Bauer, Kristen; Faix, Dennis J.; Hait, Howard; Henrick, Jennifer; Jacobs, Michael; Liss, Alan; Lynch, Julia; Liu, Qi; Lyons, Arthur; Malik, Mohammad Bilal; Moon, James E.; Stubbs, Jeremiah; Sun, Wellington; Tang, Dezhi; Towle, Andrew C.; Walsh, Douglas S.; Wilkerson, Deborah

doi:10.1016/j.vaccine.2013.04.035

Cited by 56 publications

(65 citation statements)

References 22 publications

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“…Vaccination costs $150 per person, providing a net savings of ≈$20 million ( 5 ). Phase 3 safety studies of the vaccine established an excellent safety profile ( 14 ). Surveillance safety data since 2011 should be released soon and are expected to be consistent with the Phase 3 data.…”

Section: Discussionmentioning

confidence: 99%

Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine1

Clemmons¹,

McCormic²,

Gaydos³

et al. 2017

Emerg. Infect. Dis.

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Section: Discussionmentioning

confidence: 99%

Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine1

Clemmons¹,

McCormic²,

Gaydos³

et al. 2017

Emerg. Infect. Dis.

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“…It is recommended by the Department of Defense for enlisted soldiers entering basic training but may also be encouraged for other military personnel at high risk for adenovirus infection. The vaccine is reported to prevent illness caused by these two virus types, with an efficacy of 99.3% (95% confidence interval [CI], 96.0 to 99.9%; P Ͻ 0.001), and the virus isolation rates fell dramatically after reinitiation of the vaccination program (94,95). Updates on the vaccine are available at the website of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines).…”

Section: Primary Infection and Persistencementioning

confidence: 99%

Adenovirus Infections in Immunocompetent and Immunocompromised Patients

2014

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SUMMARY Human adenoviruses (HAdVs) are an important cause of infections in both immunocompetent and immunocompromised individuals, and they continue to provide clinical challenges pertaining to diagnostics and treatment. The growing number of HAdV types identified by genomic analysis, as well as the improved understanding of the sites of viral persistence and reactivation, requires continuous adaptions of diagnostic approaches to facilitate timely detection and monitoring of HAdV infections. In view of the clinical relevance of life-threatening HAdV diseases in the immunocompromised setting, there is an urgent need for highly effective treatment modalities lacking major side effects. The present review summarizes the recent progress in the understanding and management of HAdV infections.

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“…This system identified the return of significant respiratory disease morbidity across all services during the period of adenovirus vaccination cessation (spring of 1999 through fall of 2011). Data from this project, as well as from a large, 4,000-subject, phase 3 RCT of adenovirus 4 and 7 vaccines led by NHRC and WRAIR investigators (see section on adenovirus vaccines and the military, below), have been critical in assessing adenoviral morbidity among recruits and associated Ad4 and Ad7 vaccine efficacy (612). FRI surveillance data have also been leveraged to estimate annual influenza vaccine effectiveness among recruits, as shown in Table 6 (219, 613, 614), as well as to conduct targeted serologic and vaccine strain genetic studies (615) and to characterize influenza virus strain circulation each season in a timely and consistent manner.…”

Section: Respiratory Disease Surveillance Efforts In the Us Militarymentioning

confidence: 99%

Respiratory Infections in the U.S. Military: Recent Experience and Control

et al. 2015

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SUMMARY This comprehensive review outlines the impact of military-relevant respiratory infections, with special attention to recruit training environments, influenza pandemics in 1918 to 1919 and 2009 to 2010, and peacetime operations and conflicts in the past 25 years. Outbreaks and epidemiologic investigations of viral and bacterial infections among high-risk groups are presented, including (i) experience by recruits at training centers, (ii) impact on advanced trainees in special settings, (iii) morbidity sustained by shipboard personnel at sea, and (iv) experience of deployed personnel. Utilizing a pathogen-by-pathogen approach, we examine (i) epidemiology, (ii) impact in terms of morbidity and operational readiness, (iii) clinical presentation and outbreak potential, (iv) diagnostic modalities, (v) treatment approaches, and (vi) vaccine and other control measures. We also outline military-specific initiatives in (i) surveillance, (ii) vaccine development and policy, (iii) novel influenza and coronavirus diagnostic test development and surveillance methods, (iv) influenza virus transmission and severity prediction modeling efforts, and (v) evaluation and implementation of nonvaccine, nonpharmacologic interventions.

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A phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of the live, oral adenovirus type 4 and type 7 vaccine, in U.S. military recruits

Cited by 56 publications

References 22 publications

Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine1

Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine1

Adenovirus Infections in Immunocompetent and Immunocompromised Patients

Respiratory Infections in the U.S. Military: Recent Experience and Control

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