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- Phase II and III trials, mid-2008
Phase II and III trials, mid-2008
As of mid-2008, there were over 30 trials taking place of HIV candidate vaccines worldwide. See the IAVI database of AIDS vaccines in human trials for a continuously updated list at http://www.iavireport.org/trials-db/Pages/default.aspx
- There was one Phase III efficacy trial taking place in Thailand. This is the controversial RV144 prime-boost trial using the ALVAC vCP1521 canarypox vector vaccine as prime and the AIDSVAX gp120 envelope clade B/AE subunit vaccine as boost. There are about 7000 volunteers enrolled. This started in October 2003 and is due to continue until at least 2008. Repeated Data and Safety Monitoring Board reports have concluded that it is safe to continue the trial.
- The Phase IIa HVTN204 prime-boost clades A, B and C trial of a naked DNA plasmid vaccine (VRC-HIVDNA016) as prime and the adenovirus VRC-HIVADV014-00-VP vector vaccine as boost. This started in September 2005, was taking place in the USA and Latin America, and would recruit 480 volunteers.
- The remaining studies are Phase I or Phase I/II trials of vaccine candidates that will test safety and then immunogenicity. If candidates are found to be immunogenic they will then be moved forward to larger Phase IIb proof-of-concept studies.
- Participants in the STEP and Phambili trials (halted in September 2007) continue to be followed up and monitored to determine whether the vaccine used in these studies increases the risk of HIV infection for any sub-group of participants (see below).