Elsevier

Vaccine

Volume 26, Issue 35, 18 August 2008, Pages 4420-4424
Vaccine

Short communication
The safety and tolerability of an HIV-1 DNA prime–protein boost vaccine (DP6-001) in healthy adult volunteers

https://doi.org/10.1016/j.vaccine.2008.05.090Get rights and content

Abstract

This report describes the safety observations following administration of a polyvalent DNA prime–protein boost HIV-1 vaccine formulated with adjuvant QS21. Local injection site reactions were the most common (65% of subjects), and included type IV delayed-type hypersensitivity (DTH) reactions at prior DNA inoculation sites in 12 of 28 (43%) subjects following protein vaccination. Systemic reactions revealed two cases of vasculitis temporally related to inoculation with recombinant Env protein + QS21 adjuvant. Questions remain regarding the cause of the vasculitis, but the unique DTH observation may have contributed to the high level of immune responses previously reported for this vaccine.

Section snippets

Acknowledgements

We are grateful to the volunteers in this study for their dedication, passion and willingness to participate in the critical role of testing an experimental HIV vaccine. We express our appreciation to the members of our scientific advisory board, DAIDS-NIH and in particular Drs. Stuart Shapiro, Alan Fix, Dale Lawrence of DAIDS-NIH, and Francis Ennis, UMMS for their insightful comments, discussions and scientific expertise in bringing this vaccine from the concept stage to human clinical trials.

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