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. Author manuscript; available in PMC: 2016 Feb 4.
Published in final edited form as: Vaccine. 2014 Oct 23;33(6):749–752. doi: 10.1016/j.vaccine.2014.10.017

Table 1.

Trial design features of Phase 1 preventive HIV vaccine clinical trials with and without the inclusion of placebo recipients.

Endpoint Design Feature Trial Design
Both vaccine and placebo recipients included Only vaccine recipients included
Safety In-study control group for blinding Yes No (but may blind across multiple vaccine groups)
In study reference group for comparison Yes (but of limited power) No (but may use data from other studies in similar populations, with similar vaccine schedules and administration routes)
Immunogenicity In-study control group for blinding Yes No (but may use a labeling system to blind with other samples)
In study reference group for comparison Yes (but of limited power) No (but may use within-subject baseline data when available and appropriate)
Cost Within-study cost-saving No Yes
Overall development cost-saving Variable, depending on the safety/tolerability and immunogenicity of the vaccine candidate