Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study

Harrer T, Plettenberg A, Arasteh K, Van Lunzen J, Faetkenheuer G, Jaeger H, Janssens M, Burny W, Collard A, Roman F, Loeliger A, Koutsoukos M, Bourguignon P, Lavreys L, Voss G (2014)

Publication Type: Journal article

Publication year: 2014

Journal

Vaccine Elsevier

Book Volume: 32

Pages Range: 2657-65

Journal Issue: 22

DOI: 10.1016/j.vaccine.2013.10.030

Abstract

The human immunodeficiency virus type-1 (HIV-1) vaccine candidate F4/AS01 has previously been shown to induce potent and persistent polyfunctional CD4(+) T-cell responses in HIV-1-seronegative volunteers. This placebo-controlled study evaluated two doses of F4/AS01 1-month apart in antiretroviral treatment (ART)-experienced and ART-naïve HIV-1-infected subjects (1:1 randomisation in each cohort). Safety, HIV-1-specific CD4(+) and CD8(+) T-cell responses, absolute CD4(+) T-cell counts and HIV-1 viral load were monitored for 12 months post-vaccination. Reactogenicity was clinically acceptable and no vaccine-related serious adverse events were reported. The frequency of HIV-1-specific CD4(+) T-cells 2 weeks post-dose 2 was significantly higher in the vaccine group than in the placebo group in both cohorts (p<0.05). Vaccine-induced HIV-1-specific CD4(+) T-cells exhibited a polyfunctional phenotype, expressing at least CD40L and IL-2. No increase in HIV-1-specific CD8(+) T-cells or change in CD8(+) T-cell activation marker expression profile was detected. Absolute CD4(+) T-cell counts were variable over time in both cohorts. Viral load remained suppressed in ART-experienced subjects. In ART-naïve subjects, a transient reduction in viral load from baseline was observed 2 weeks after the second F4/AS01 dose, which was concurrent with a higher frequency of HIV-1-specific CD4(+) T-cells expressing at least IL-2 in this cohort. In conclusion, F4/AS01 showed a clinically acceptable reactogenicity and safety profile, and induced polyfunctional HIV-1-specific CD4(+) T-cell responses in ART-experienced and ART-naïve subjects. These findings support further clinical investigation of F4/AS01 as a potential HIV-1 vaccine for therapeutic use in individuals with HIV-1 infection.

Authors with CRIS profile

Thomas Harrer Professur für Innere Medizin mit dem Schwerpunkt Immundefizienz

Involved external institutions

Asklepios Kliniken DE Germany (DE) Vivantes - Netzwerk für Gesundheit GmbH DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) Universität zu Köln DE Germany (DE) GlaxoSmithKline (GSK) (Belgium) BE Belgium (BE)

How to cite

APA:

Harrer, T., Plettenberg, A., Arasteh, K., Van Lunzen, J., Faetkenheuer, G., Jaeger, H.,... Voss, G. (2014). Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study. Vaccine, 32(22), 2657-65. https://doi.org/10.1016/j.vaccine.2013.10.030

MLA:

Harrer, Thomas, et al. "Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study." Vaccine 32.22 (2014): 2657-65.

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