Newman, M.J.Jin, X.De-Rosa, S.Cooper, C.Thomas, E.Keefer, M.Fuchs, J.Blattner, W.Livingston, B.D.McKinney, D.M.Noonan, E.Decamp, A.Defawe, O.D.Wecker, M.2012-05-172017-10-192012-05-172017-10-192009Vaccine Journal. 27(50): 7080-6http://197.255.68.203/handle/123456789/1484A Phase I human vaccine trial of a novel polypeptide vaccine of HIV T helper epitopes (EP-1043) and a DNA vaccine of HIV CTL epitopes was conducted in 84 healthy adult volunteers. The vaccine immunogenicity was assessed by an intracellular cytokine staining assay for IL-2, IL-4, TNF-alpha and IFN-gamma. Sixty eight percent (32/47) of subjects had a positive CD4+ T response after receiving two vaccinations of the polypeptide vaccine. The responding CD4+ T cells made various combinations of IL-2, IL-4, IFN-gamma, and TNF-alpha. The study demonstrated that the EP-1043 vaccine is safe, well-tolerated, and immunogenic.enA novel HIV T helper epitope-based vaccine elicits cytokine-secreting HIV-specific CD4+ T cells in a Phase I clinical trial in HIV-uninfected adultsArticle