Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial
IntroductionFunctional cure has been proposed as an alternative to lifelong antiretroviral therapy and therapeutic vaccines represent one of the most promising approaches.Materials and MethodsWe conducted a double-blind randomized placebo-controlled clinical trial to evaluate the safety, immunogenic...
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Frontiers Media S.A.
2021
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oai:doaj.org-article:a8aaf114260f4143b36d72f882f69ca32021-11-11T07:13:44ZEffect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial1664-322410.3389/fimmu.2021.767370https://doaj.org/article/a8aaf114260f4143b36d72f882f69ca32021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fimmu.2021.767370/fullhttps://doaj.org/toc/1664-3224IntroductionFunctional cure has been proposed as an alternative to lifelong antiretroviral therapy and therapeutic vaccines represent one of the most promising approaches.Materials and MethodsWe conducted a double-blind randomized placebo-controlled clinical trial to evaluate the safety, immunogenicity, and effect on viral dynamics of a therapeutic vaccine produced with monocyte-derived dendritic cells (MD-DC) loaded with a high dose of heat-inactivated autologous (HIA) HIV-1 in combination with pegylated interferon alpha 2a (IFNα-2a) in people with chronic HIV-1.ResultsTwenty-nine male individuals on successful ART and with CD4+ ≥450 cells/mm3 were randomized 1:1:1:1 to receive three ultrasound-guided inguinal intranodal immunizations, one every 2 weeks: (1) vaccine ~107 MD-DC pulsed with HIA-HIV-1 (1010 HIV RNA copies) (n = 8); (2) vaccine plus three doses of 180 mcg IFNα-2a at weeks 4–6 (n = 6); (3) placebo = saline (n = 7); and (4) placebo plus three doses of 180 mcg IFNα-2a (n = 8). Thereafter, treatment was interrupted (ATI). Vaccines, IFNα-2a, and the administration procedures were safe and well tolerated. All patients’ viral load rebounded during the 12-week ATI period. According to groups, changes in viral set-point between pre-ART and during ATI were not significant. When comparing all groups, there was a tendency in changes in viral set-point between the vaccine group vs. vaccine + IFNα-2a group (>0.5log10p = 0.05). HIV-1-specific T-cell responses (IFN-ƴ Elispot) were higher at baseline in placebo than in the vaccine group (2,259 ± 535 vs. 900 ± 200 SFC/106 PBMC, p = 0.028). A significant difference in the change of specific T-cell responses was only observed at week 4 between vaccine and placebo groups (694 ± 327 vs. 1,718 ± 282 SFC/106 PBMC, p = 0.04). No effect on T-cell responses or changes in viral reservoir were observed after INFα-2a administration.DiscussionResults from this study show that intranodally administered DC therapeutic vaccine in combination with IFNα-2a was safe and well-tolerated but had a minimal impact on viral dynamics in HIV-1 chronic infected participants.Clinical Trial Registration(www.ClinicalTrials.gov), identifier NCT02767193Lorna LealLorna LealLorna LealElvira CoutoElvira CoutoSonsoles Sánchez-PalominoNúria ClimentIrene FernándezIrene FernándezLaia MirallesYolanda RomeroYolanda RomeroTania GonzálezMaria José MalenoBlanca PañoJudit PichCarlos NicolauCarlos NicolauJosé Maria GatellJosé Maria GatellJosé Maria GatellJosé Maria GatellMontserrat PlanaMontserrat PlanaFelipe GarcíaFelipe GarcíaFelipe Garcíathe DCV3-RISVAC04 Study GroupLorna LealIrene FernándezElvira CoutoYolanda RomeroLaia MirallesCarmen HurtadoNúria ClimentTania GonzálezMaria José MalenoJudit PichLaura BurunatJoan Albert ArnaizBlanca PañoCarlos NicolauRafael SalvadorElisabet FarréSonsoles Sánchez-PalominoJosé Maria GatellMontserrat PlanaFelipe GarcíaBerta TorresConstanza LuceroMontserrat LagunoMaría Martínez-RebollarAna González-CordónJohn RojasAlexy InciarteLorena de la MoraJosep MallolasEsteban MartínezJosé Luis BlancoUnai PerpiñáJosep CanalsRaquel MartínFlorencia EcheverryCristina XufréCristina RoviraMarta SalaAmparo TricasFrontiers Media S.A.articletherapeutic vaccinedendritic cellinterferon alphacombined strategyATIImmunologic diseases. AllergyRC581-607ENFrontiers in Immunology, Vol 12 (2021) |
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DOAJ |
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therapeutic vaccine dendritic cell interferon alpha combined strategy ATI Immunologic diseases. Allergy RC581-607 |
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therapeutic vaccine dendritic cell interferon alpha combined strategy ATI Immunologic diseases. Allergy RC581-607 Lorna Leal Lorna Leal Lorna Leal Elvira Couto Elvira Couto Sonsoles Sánchez-Palomino Núria Climent Irene Fernández Irene Fernández Laia Miralles Yolanda Romero Yolanda Romero Tania González Maria José Maleno Blanca Paño Judit Pich Carlos Nicolau Carlos Nicolau José Maria Gatell José Maria Gatell José Maria Gatell José Maria Gatell Montserrat Plana Montserrat Plana Felipe García Felipe García Felipe García the DCV3-RISVAC04 Study Group Lorna Leal Irene Fernández Elvira Couto Yolanda Romero Laia Miralles Carmen Hurtado Núria Climent Tania González Maria José Maleno Judit Pich Laura Burunat Joan Albert Arnaiz Blanca Paño Carlos Nicolau Rafael Salvador Elisabet Farré Sonsoles Sánchez-Palomino José Maria Gatell Montserrat Plana Felipe García Berta Torres Constanza Lucero Montserrat Laguno María Martínez-Rebollar Ana González-Cordón John Rojas Alexy Inciarte Lorena de la Mora Josep Mallolas Esteban Martínez José Luis Blanco Unai Perpiñá Josep Canals Raquel Martín Florencia Echeverry Cristina Xufré Cristina Rovira Marta Sala Amparo Tricas Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| description |
IntroductionFunctional cure has been proposed as an alternative to lifelong antiretroviral therapy and therapeutic vaccines represent one of the most promising approaches.Materials and MethodsWe conducted a double-blind randomized placebo-controlled clinical trial to evaluate the safety, immunogenicity, and effect on viral dynamics of a therapeutic vaccine produced with monocyte-derived dendritic cells (MD-DC) loaded with a high dose of heat-inactivated autologous (HIA) HIV-1 in combination with pegylated interferon alpha 2a (IFNα-2a) in people with chronic HIV-1.ResultsTwenty-nine male individuals on successful ART and with CD4+ ≥450 cells/mm3 were randomized 1:1:1:1 to receive three ultrasound-guided inguinal intranodal immunizations, one every 2 weeks: (1) vaccine ~107 MD-DC pulsed with HIA-HIV-1 (1010 HIV RNA copies) (n = 8); (2) vaccine plus three doses of 180 mcg IFNα-2a at weeks 4–6 (n = 6); (3) placebo = saline (n = 7); and (4) placebo plus three doses of 180 mcg IFNα-2a (n = 8). Thereafter, treatment was interrupted (ATI). Vaccines, IFNα-2a, and the administration procedures were safe and well tolerated. All patients’ viral load rebounded during the 12-week ATI period. According to groups, changes in viral set-point between pre-ART and during ATI were not significant. When comparing all groups, there was a tendency in changes in viral set-point between the vaccine group vs. vaccine + IFNα-2a group (>0.5log10p = 0.05). HIV-1-specific T-cell responses (IFN-ƴ Elispot) were higher at baseline in placebo than in the vaccine group (2,259 ± 535 vs. 900 ± 200 SFC/106 PBMC, p = 0.028). A significant difference in the change of specific T-cell responses was only observed at week 4 between vaccine and placebo groups (694 ± 327 vs. 1,718 ± 282 SFC/106 PBMC, p = 0.04). No effect on T-cell responses or changes in viral reservoir were observed after INFα-2a administration.DiscussionResults from this study show that intranodally administered DC therapeutic vaccine in combination with IFNα-2a was safe and well-tolerated but had a minimal impact on viral dynamics in HIV-1 chronic infected participants.Clinical Trial Registration(www.ClinicalTrials.gov), identifier NCT02767193 |
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article |
| author |
Lorna Leal Lorna Leal Lorna Leal Elvira Couto Elvira Couto Sonsoles Sánchez-Palomino Núria Climent Irene Fernández Irene Fernández Laia Miralles Yolanda Romero Yolanda Romero Tania González Maria José Maleno Blanca Paño Judit Pich Carlos Nicolau Carlos Nicolau José Maria Gatell José Maria Gatell José Maria Gatell José Maria Gatell Montserrat Plana Montserrat Plana Felipe García Felipe García Felipe García the DCV3-RISVAC04 Study Group Lorna Leal Irene Fernández Elvira Couto Yolanda Romero Laia Miralles Carmen Hurtado Núria Climent Tania González Maria José Maleno Judit Pich Laura Burunat Joan Albert Arnaiz Blanca Paño Carlos Nicolau Rafael Salvador Elisabet Farré Sonsoles Sánchez-Palomino José Maria Gatell Montserrat Plana Felipe García Berta Torres Constanza Lucero Montserrat Laguno María Martínez-Rebollar Ana González-Cordón John Rojas Alexy Inciarte Lorena de la Mora Josep Mallolas Esteban Martínez José Luis Blanco Unai Perpiñá Josep Canals Raquel Martín Florencia Echeverry Cristina Xufré Cristina Rovira Marta Sala Amparo Tricas |
| author_facet |
Lorna Leal Lorna Leal Lorna Leal Elvira Couto Elvira Couto Sonsoles Sánchez-Palomino Núria Climent Irene Fernández Irene Fernández Laia Miralles Yolanda Romero Yolanda Romero Tania González Maria José Maleno Blanca Paño Judit Pich Carlos Nicolau Carlos Nicolau José Maria Gatell José Maria Gatell José Maria Gatell José Maria Gatell Montserrat Plana Montserrat Plana Felipe García Felipe García Felipe García the DCV3-RISVAC04 Study Group Lorna Leal Irene Fernández Elvira Couto Yolanda Romero Laia Miralles Carmen Hurtado Núria Climent Tania González Maria José Maleno Judit Pich Laura Burunat Joan Albert Arnaiz Blanca Paño Carlos Nicolau Rafael Salvador Elisabet Farré Sonsoles Sánchez-Palomino José Maria Gatell Montserrat Plana Felipe García Berta Torres Constanza Lucero Montserrat Laguno María Martínez-Rebollar Ana González-Cordón John Rojas Alexy Inciarte Lorena de la Mora Josep Mallolas Esteban Martínez José Luis Blanco Unai Perpiñá Josep Canals Raquel Martín Florencia Echeverry Cristina Xufré Cristina Rovira Marta Sala Amparo Tricas |
| author_sort |
Lorna Leal |
| title |
Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| title_short |
Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| title_full |
Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| title_fullStr |
Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| title_full_unstemmed |
Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon α-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial |
| title_sort |
effect of intranodally administered dendritic cell-based hiv vaccine in combination with pegylated interferon α-2a on viral control following art discontinuation: a phase 2a randomized clinical trial |
| publisher |
Frontiers Media S.A. |
| publishDate |
2021 |
| url |
https://doaj.org/article/a8aaf114260f4143b36d72f882f69ca3 |
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