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

Infectious Diseases Department, Hospital Clínic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain
Infectious Diseases Unit, Parc Sanitari Sant Joan de Deu, 08830 Sant Boi de Llobregat, Spain
Irsicaixa AIDS Research Institute-HIVACAT, Hospital Germans Trias i Pujol, 08916 Badalona, Spain
Department of Molecular and Cellular Biology, Centro Nacional de Biotecnología, Consejo Superior de Investigaciones Científicas (CNB-CSIC), Campus de Cantoblanco, 28049 Madrid, Spain
Clinical Trial Unit, Hospital Clínic, 08036 Barcelona, Spain
Infectious Diseases Department, Hospital Gregorio Marañón, 28009 Madrid, Spain
Retrovirology and Viral Immunopathology, AIDS Research Group, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain
Author to whom correspondence should be addressed.
These authors contributed equally.
Vaccines 2019, 7(4), 178;
Received: 22 October 2019 / Revised: 1 November 2019 / Accepted: 4 November 2019 / Published: 7 November 2019
(This article belongs to the Section HIV Vaccines)
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. View Full-Text
Keywords: vaccine; HIV-1; preventive; therapeutic; MVA-B vaccine; HIV-1; preventive; therapeutic; MVA-B
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Couto, E.; Diaz-Brito, V.; Mothe, B.; Guardo, A.C.; Fernandez, I.; Ugarte, A.; Etcheverry, F.; Gómez, C.E.; Esteban, M.; Pich, J.; Arnaiz, J.A.; López Bernaldo de Quirós, J.C.; Brander, C.; Plana, M.; García, F.; Leal, L. Comparison of Safety and Vector-Specific Immune Responses in Healthy and HIV-Infected Populations Vaccinated with MVA-B. Vaccines 2019, 7, 178.

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