Advances in human clinical trials of vaccines to prevent HIV/AIDS and other HIV prevention interventions.
Nearly three decades after the first description in 1981 of the syndrome eventually designated as AIDS, only five efficacy trials testing just three HIV vaccine concepts have been initiated. In 2007, an efficacy analysis was conducted for the first of a newer generation of candidate HIV/AIDS vaccines based entirely on cellular immunity. Data from this study, known as the Step Study, indicated that the vaccine neither protected against infection nor lowered viral loads after infection. Furthermore, certain vaccinees were at higher risk of HIV infection following vaccination. This article explores these disappointing and surprising outcomes, reviews earlier efficacy studies and more recent discovery research, and provides a critical analysis of the field. Other HIV prevention interventions are considered because their successful implementation may dramatically alter the milieu for future HIV vaccine field trials, particularly impacting study designs and increasing sample sizes if incidence falls.
Mulligan
Mark J
MJ
Division of Infectious Diseases, Emory University, 603 Church Street, Decatur, GA 30030, USA. mark.mulligan@emory.edu
Lancet. 2008 Jun 21;371(9630):2109-19
18572080
Clin Infect Dis. 2008 Jun 1;46(11):1769-81
18433307
Lancet. 1999 Sep 4;354(9181):795-802
10485720
Lancet. 2007 Feb 24;369(9562):657-66
17321311
J Infect Dis. 2005 Mar 1;191(5):654-65
15688278
J Infect Dis. 2005 Mar 1;191(5):666-77
15688279
Lancet. 2008 Nov 29;372(9653):1881-1893
19012954
AIDS Res Hum Retroviruses. 2001 Jul 1;17(10):901-10
11461676
Lancet. 2008 Dec 6;372(9654):1977-87
19059048
Science. 2008 Jul 25;321(5888):472
18653850
PLoS Med. 2005 Nov;2(11):e298
16231970
J Infect Dis. 2004 Aug 15;190(4):702-6
15272397
Lancet. 2007 Jul 21;370(9583):251-261
17631387
J Virol. 2005 Oct;79(19):12321-31
16160159
J Infect Dis. 2006 Dec 15;194(12):1661-71
17109337
J Acquir Immune Defic Syndr. 2007 Feb 1;44(2):203-12
17106277
Science. 2008 Jul 25;321(5888):530-2
18653883
Lancet. 2007 Feb 24;369(9562):643-56
17321310
N Engl J Med. 2000 Mar 30;342(13):921-9
10738050
N Engl J Med. 2008 Jul 31;359(5):463-72
18669425
Am J Public Health. 2007 Jan;97(1):133-43
17138920
JAMA. 2008 Aug 6;300(5):520-9
18677024