Abstract
On September 21, 2007, the world’s first large clinical trial1 of a T-cell vaccine for HIV/AIDS was terminated prematurely by the Data Safety and Monitoring Board (DSMB).
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
“Phase-IIb”: a trial design intended to quickly detect lack of efficacy, rather than ensure licensure.
- 2.
The sequences chosen were near-consensus clade B and codon-optimized.
- 3.
Among 1,850 men and 1,150 women enrolled meeting either protocol requirements.
- 4.
It is due to an historical accident dating to the 1920s: two premier statisticians fought over publication of statistical tables, which then were prepared by “computers” (usually retired algebra teachers) and consequently very expensive. R. A. Fisher, inventor of the p-value, could only acquire the.1 and.05 tables; hence the origin of the “5-percent rule” that permits publication in journals.
- 5.
The Statistical Center for HIV/AIDS Research and Prevention, located at the Fred Hutchinson Cancer Research Center in Seattle; the statistical analysis arm of the HVTN, at which an author worked from 1996–2011.
- 6.
The authors thank Fusheng Li of the HVTN for these observations.
- 7.
Strain E660.
- 8.
This may be regarded as fulfilling a model-based prediction by an author and colleagues: namely, that T-cells alone may be able to halt a retrovirus infection in its tracks. See [316].
- 9.
The theory is that, while it may be difficult to vary an essential gene without losing viability, once the gene is duplicated the spare one is free for evolutionary experiments.
- 10.
The spectacular footage was included in the movie “The Right Stuff”; the actors, playing would-be astronauts hoping to ride the rocket into space, provide the appropriate reactions.
Bibliography
Rolland M, Tovanabutra S, deCamp AC, Frahm N, Gilbert PB, Sanders-Buell E, Heath L, Magaret CA, Bose M, Bradfield A, O’Sullivan A, Crossler J, Jones T, Nau M, Wong K, Zhao H, Raugi DN, Sorensen S, Stoddard JN, Maust BS, Deng W, Hural J, Dubey S, Michael NL, Shiver J, Corey L, Li F, Self SG, Kim J, Buchbinder S, Casimiro DR, Robertson MN, Duerr A, McElrath MJ, McCutchan FE, Mullins JI (2011) Genetic impact of vaccination on breakthrough HIV-1 sequences from the STEP trial. Nat Med 17(3):366–371. doi:10.1038/nm.2316. Epub 2011 Feb 27
Wick WD, Gilbert PB, Self SG (2006) On modeling HIV and T cells in vivo: assessing casual estimators in vaccine trials. PLoS Comput Biol 2(6). dx.doi.org/10.1371/journal.pcbi.0020064
Yang OO (2003) Will we be able to ‘spot’ an effective HIV-1 vaccine? Trends Immunol 24:67–72
Yang OO (2004) CTL ontogeny and viral escape: implications for HIV-1 vaccine design. Trends Immunol 25(3):138–42
Yang OO (2007) Invited talk at the AIDS vaccine 2007 conference, entitled “CTL and the control of HIV-1 replication,” 22 August 2007, Seattle. http://www.vaccineenterprise.org/conference_archive/2007/program.html
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media New York
About this chapter
Cite this chapter
Wick, W.D., Yang, O.O. (2013). The STEP Trial, Monkey Trials, and the Future of T-Cell Vaccines. In: War in the Body. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7294-0_13
Download citation
DOI: https://doi.org/10.1007/978-1-4614-7294-0_13
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-7293-3
Online ISBN: 978-1-4614-7294-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)