Longitudinal study to assess the safety and efficacy of a live-attenuated SHIV vaccine in long term immunized rhesus macaques

AbstractLive-attenuated viruses derived from SIV and SHIV have provided the most consistent protection against challenge with pathogenic viruses, but concerns regarding their long-term safety and efficacy have hampered their clinical usefulness. We report a longitudinal study in which we evaluated the long-term safety and efficacy of ΔvpuSHIVPPC, a live virus vaccine derived from SHIVPPC. Macaques were administered two inoculations of ΔvpuSHIVPPC, three years apart, and followed for eight years. None of the five vaccinated macaques developed an AIDS-like disease from the vaccine. At eight years, macaques were challenged with pathogenic SIV and SHIV. None of the four macaques with detectable cellular-mediated immunity prior to challenge had detectable viral RNA in the plasma. This study demonstrates that multiple inoculations of a live vaccine virus can be used safely and can significantly extend the efficacy of the vaccine, as compared to a single inoculation, which is efficacious for approximately three years

The Story of Vermont Yankee: A Cautionary Tale of Judicial Review and Nuclear Waste

This Essay explores the puzzle of Vermont Yankee v. NRDC. Vermont Yankee stands as a definitive rejection of judicial efforts to control burgeoning informal rulemaking by adding to the procedural requirements contained in the Administrative Procedure Act. Yet judicial expansion of the APA\u27s procedural requirements has continued apace, and the Court\u27s simultaneous sanction of searching substantive scrutiny sits oddly with its excoriation of the D.C. Circuit for that court\u27s perceived procedural excesses. To understand Vermont Yankee, the Essay puts the decision in its administrative and judicial context, exploring the case law and practical dilemmas facing administrators, advocates, and judges as the case unfolded. The Essay argues Vermont Yankee is very much a creature of its time, when dramatic expansions in congressionally-mandated regulation led to multiple political and institutional struggles – between advocates and agencies, between agencies and courts, and between the Supreme Court and the D.C. Circuit. But the cautionary tale of Vermont Yankee has broader significance and demonstrates the challenges facing judicial review in the modern administrative state