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This study was partially supported by grants: the European Commission (grants: H2020-SC1-2016-RTD, Proposal: 731626), the Spanish Ministry of Economy (MINECO) (grants: SAF2015-66193-R, RTI2018-096309-B-I00, EC10-153, TRA-094), the Fondo de Investigacion Sanitaria (FIS) (PI15/00480, AC16/00051, and PI18/00699), the Fondo Europeo para el Desarrollo Regional (FEDER), the SPANISH AIDS Research Network RD16/0025/0002-ISCIII-FEDER (RIS), and the CERCA Programme/Generalitat de Catalunya (SGR 615). F.G. has received the support of Jose Maria Segovia de Arana contracts. HIVACAT: HIV development program in Catalonia. IDIBAPS: Institut d'Investigacions Biomediques August Pi I Sunyer.

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Comparison of Safety and Vector-Specific Immune Responses in Healthy and HIV-Infected Populations Vaccinated with MVA-B

Publicat a:Vaccines. 7 (4): E178- - 2019-12-01 7(4), DOI: 10.3390/vaccines7040178

Autors: Couto, Elvira; Diaz-Brito, Vicenc; Mothe, Beatriz; Guardo, Alberto C; Fernandez, Irene; Ugarte, Ainoa; Etcheverry, Flor; Gomez, Carmen E; Esteban, Mariano; Pich, Judit; Arnaiz, Joan Albert; Lopez Bernaldo de Quiros, Juan Carlos; Brander, Christian; Plana, Montserrat; Garcia, Felipe; Leal, Lorna

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There are few studies comparing the safety and immunogenicity of the same HIV immunogen in healthy volunteers and HIV-infected individuals. We analyzed demographics, adverse events (AEs), and immunogenicity against vaccinia virus in preventive (RISVAC02, n = 24 low-risk HIV-negative volunteers) and therapeutic (RISVAC03, n = 20 successfully treated chronically HIV-1-infected individuals) vaccine phase-I clinical trials that were performed with the same design and the same immunogen (modified vaccinia virus Ankara-B: MVA-B). Total AEs were significantly higher in HIV-infected patients (mean AEs/patient 6.6 vs. 12.8 (p < 0.01)). Conversely, the number of AEs related to vaccination (AEsRV) was similar between both groups. No grade III or IV AEsRV were observed in either clinical trial. Regarding the immunogenicity, the proportion of anti-vaccinia virus antibody responders was similar in both studies. Conversely, the magnitude of response was significantly higher in HIV-infected patients (median binding antibodies at w8 267 vs. 1600 U/mL (p = 0.002) and at w18 666 vs. 3200 U/mL (p = 0.003)). There was also a trend towards higher anti-vaccinia virus neutralizing activity in HIV-infected individuals (proportion of responders 37% vs. 63% (p = 0.09); median IC50 32 vs. 64 (p = 0.054)). This study confirms the safety of MVA-B independent of HIV serostatus. HIV-infected patients showed higher immune responses against vaccinia virus.

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