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

Thomas Harrer; Andreas Plettenberg; Keikawus Arastéh; Jan Van Lunzen; Gerd Fätkenheuer; Hans Jaeger; Michel Janssens; Wivine Burny; Alix Collard; François Roman; Alfred Loeliger; Marguerite Koutsoukos; Patricia Bourguignon; Ludo Lavreys; Gerald Voss

doi:10.1016/j.vaccine.2013.10.030

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

Standard

Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study. / Harrer, Thomas; Plettenberg, Andreas; Arastéh, Keikawus; Van Lunzen, Jan; Fätkenheuer, Gerd; Jaeger, Hans; Janssens, Michel; Burny, Wivine; Collard, Alix; Roman, François; Loeliger, Alfred; Koutsoukos, Marguerite; Bourguignon, Patricia; Lavreys, Ludo; Voss, Gerald.

in: VACCINE, Jahrgang 32, Nr. 22, 07.05.2014, S. 2657-2665.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Harrer, T, Plettenberg, A, Arastéh, K, Van Lunzen, J, Fätkenheuer, G, Jaeger, H, Janssens, M, Burny, W, Collard, A, Roman, F, Loeliger, A, Koutsoukos, M, Bourguignon, P, Lavreys, L & 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, Jg. 32, Nr. 22, S. 2657-2665. https://doi.org/10.1016/j.vaccine.2013.10.030

APA

Harrer, T., Plettenberg, A., Arastéh, K., Van Lunzen, J., Fätkenheuer, G., Jaeger, H., Janssens, M., Burny, W., Collard, A., Roman, F., Loeliger, A., Koutsoukos, M., Bourguignon, P., Lavreys, L., & 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), 2657-2665. https://doi.org/10.1016/j.vaccine.2013.10.030

Vancouver

Harrer T, Plettenberg A, Arastéh K, Van Lunzen J, Fätkenheuer G, Jaeger H 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. 2014 Mai 7;32(22):2657-2665. https://doi.org/10.1016/j.vaccine.2013.10.030

Bibtex

@article{2e5dd9663b134d669755289902556ad7,

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

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-na{\"i}ve 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-na{\"i}ve 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-na{\"i}ve 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.",

author = "Thomas Harrer and Andreas Plettenberg and Keikawus Arast{\'e}h and {Van Lunzen}, Jan and Gerd F{\"a}tkenheuer and Hans Jaeger and Michel Janssens and Wivine Burny and Alix Collard and Fran{\c c}ois Roman and Alfred Loeliger and Marguerite Koutsoukos and Patricia Bourguignon and Ludo Lavreys and Gerald Voss",

year = "2014",

month = may,

day = "7",

doi = "10.1016/j.vaccine.2013.10.030",

language = "English",

volume = "32",

pages = "2657--2665",

journal = "VACCINE",

issn = "0264-410X",

publisher = "Elsevier BV",

number = "22",

}

RIS

TY - JOUR

T1 - Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study

AU - Harrer, Thomas

AU - Plettenberg, Andreas

AU - Arastéh, Keikawus

AU - Van Lunzen, Jan

AU - Fätkenheuer, Gerd

AU - Jaeger, Hans

AU - Janssens, Michel

AU - Burny, Wivine

AU - Collard, Alix

AU - Roman, François

AU - Loeliger, Alfred

AU - Koutsoukos, Marguerite

AU - Bourguignon, Patricia

AU - Lavreys, Ludo

AU - Voss, Gerald

PY - 2014/5/7

Y1 - 2014/5/7

N2 - 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.

AB - 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.

U2 - 10.1016/j.vaccine.2013.10.030

DO - 10.1016/j.vaccine.2013.10.030

M3 - SCORING: Journal article

C2 - 24144472

VL - 32

SP - 2657

EP - 2665

JO - VACCINE

JF - VACCINE

SN - 0264-410X

IS - 22

ER -