PMID- 31703287 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200928 IS - 2076-393X (Print) IS - 2076-393X (Electronic) IS - 2076-393X (Linking) VI - 7 IP - 4 DP - 2019 Nov 7 TI - Comparison of Safety and Vector-Specific Immune Responses in Healthy and HIV-Infected Populations Vaccinated with MVA-B. LID - 10.3390/vaccines7040178 [doi] LID - 178 AB - 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. FAU - Couto, Elvira AU - Couto E AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Diaz-Brito, Vicenc AU - Diaz-Brito V AUID- ORCID: 0000-0002-9734-9334 AD - Infectious Diseases Unit, Parc Sanitari Sant Joan de Deu, 08830 Sant Boi de Llobregat, Spain. FAU - Mothe, Beatriz AU - Mothe B AD - Irsicaixa AIDS Research Institute-HIVACAT, Hospital Germans Trias i Pujol, 08916 Badalona, Spain. FAU - Guardo, Alberto C AU - Guardo AC AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Fernandez, Irene AU - Fernandez I AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Ugarte, Ainoa AU - Ugarte A AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Etcheverry, Flor AU - Etcheverry F AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Gomez, Carmen E AU - Gomez CE AUID- ORCID: 0000-0002-5414-7935 AD - Department of Molecular and Cellular Biology, Centro Nacional de Biotecnologia, Consejo Superior de Investigaciones Cientificas (CNB-CSIC), Campus de Cantoblanco, 28049 Madrid, Spain. FAU - Esteban, Mariano AU - Esteban M AD - Department of Molecular and Cellular Biology, Centro Nacional de Biotecnologia, Consejo Superior de Investigaciones Cientificas (CNB-CSIC), Campus de Cantoblanco, 28049 Madrid, Spain. FAU - Pich, Judit AU - Pich J AD - Clinical Trial Unit, Hospital Clinic, 08036 Barcelona, Spain. FAU - Arnaiz, Joan Albert AU - Arnaiz JA AD - Clinical Trial Unit, Hospital Clinic, 08036 Barcelona, Spain. FAU - Lopez Bernaldo de Quiros, Juan Carlos AU - Lopez Bernaldo de Quiros JC AD - Infectious Diseases Department, Hospital Gregorio Maranon, 28009 Madrid, Spain. FAU - Brander, Christian AU - Brander C AD - Irsicaixa AIDS Research Institute-HIVACAT, Hospital Germans Trias i Pujol, 08916 Badalona, Spain. FAU - Plana, Montserrat AU - Plana M AD - Retrovirology and Viral Immunopathology, AIDS Research Group, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain. FAU - Garcia, Felipe AU - Garcia F AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. FAU - Leal, Lorna AU - Leal L AD - Infectious Diseases Department, Hospital Clinic-HIVACAT, IDIBAPS, University of Barcelona, 08036 Barcelona, Spain. LA - eng GR - SAF2015-66193-R/Ministerio de Economia y Competitividad/ GR - RTI2018-096309-B-I00/Ministerio de Economia y Competitividad/ GR - EC10-153/Ministerio de Economia y Competitividad/ GR - TRA-094/Ministerio de Economia y Competitividad/ GR - Fondo de Investigacion Sanitaria (FIS) PI15/00480/Instituto de Salud Carlos III/ GR - Fondo de Investigacion Sanitaria (FIS) AC16/00051/Instituto de Salud Carlos III/ GR - Fondo de Investigacion Sanitaria (FIS) PI18/ 00699/Instituto de Salud Carlos III/ GR - Fondo Europeo para el Desarrollo Regional (FEDER), the SPANISH AIDS Research Network RD16/0025/0002- ISCIII - FEDER (RIS)/Instituto de Salud Carlos III/ GR - CERCA Programme / Generalitat de Catalunya SGR 615/Generalitat de Catalunya/ GR - H2020-SC1-2016-RTD Proposal: 731626/European Commission/ PT - Journal Article DEP - 20191107 PL - Switzerland TA - Vaccines (Basel) JT - Vaccines JID - 101629355 PMC - PMC6963361 OTO - NOTNLM OT - HIV-1 OT - MVA-B OT - preventive OT - therapeutic OT - vaccine COIS- The authors have declared that no competing interests exist. EDAT- 2019/11/11 06:00 MHDA- 2019/11/11 06:01 PMCR- 2019/11/07 CRDT- 2019/11/10 06:00 PHST- 2019/10/22 00:00 [received] PHST- 2019/11/01 00:00 [revised] PHST- 2019/11/04 00:00 [accepted] PHST- 2019/11/10 06:00 [entrez] PHST- 2019/11/11 06:00 [pubmed] PHST- 2019/11/11 06:01 [medline] PHST- 2019/11/07 00:00 [pmc-release] AID - vaccines7040178 [pii] AID - vaccines-07-00178 [pii] AID - 10.3390/vaccines7040178 [doi] PST - epublish SO - Vaccines (Basel). 2019 Nov 7;7(4):178. doi: 10.3390/vaccines7040178.