Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of a Modified Vaccinia Ankara (MVA) Vectored HIV-1 (ADMVA) Vaccine Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers

The purpose of this study is to determine the safety of an immune response to an investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not infected with HIV

开始日期2005-01-01

申办/合作机构

International AIDS Vaccine Initiative, Inc.

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100 项与 Recombinant modified vaccinia Ankara vaccine(The Aaron Diamond AIDS Research Center) 相关的临床结果

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100 项与 Recombinant modified vaccinia Ankara vaccine(The Aaron Diamond AIDS Research Center) 相关的转化医学

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100 项与 Recombinant modified vaccinia Ankara vaccine(The Aaron Diamond AIDS Research Center) 相关的专利（医药）

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229

项与 Recombinant modified vaccinia Ankara vaccine(The Aaron Diamond AIDS Research Center) 相关的文献（医药）

2024-10-01·Vaccine

Superior protection against paratuberculosis by a heterologous prime-boost immunization in a murine model

Article

作者: Cuerda, María Ximena ; de la Paz Santangelo, María ; Gravisaco, María José ; Moyano, Roberto Damián ; Pinedo, María Fiorella Alvarado ; Delgado, Fernando Oscar ; Calamante, Gabriela ; Mundo, Silvia ; Del Medico Zajac, María Paula ; Romano, María Isabel ; Alonso, María Natalia ; Colombatti Olivieri, María Alejandra

Vaccination is the best strategy to control Paratuberculosis (PTB), which is a significant disease in cattle and sheep. Previously we showed the humoral and cellular immune response induced by a novel vaccine candidate against PTB based on the Argentinian Mycobacterium avium subspecies paratuberculosis (Map) 6611 strain. To improve 6611 immunogenicity and efficacy, we evaluated this vaccine candidate in mice with two different adjuvants and a heterologous boost with a recombinant modified vaccinia Ankara virus (MVA) expressing the antigen 85A (MVA85A). We observed that boosting with MVA85A did not improve total IgG or specific isotypes in serum induced by one or two doses of 6611 formulated with incomplete Freund's adjuvant (IFA). However, when 6611 was formulated with ISA201 adjuvant, MVA85A boost enhanced the production of IFNγ, Th1/Th17 cytokines (IL-2, TNF, IL-17A) and IL-6, IL-4 and IL-10. Also, this group showed the highest levels of IgG2b and IgG3 isotypes, both important for better protection against Map infection in the murine model. Finally, the heterologous scheme elicited the highest levels of protection after Map challenge (lowest CFU count and liver lesion score). In conclusion, our results encourage further evaluation of 6611 strain + ISA201 prime and MVA85A boost in bovines.

2024-10-01·The Lancet Infectious Diseases

Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial

Article

作者: Krähling, Verena ; Rottstegge, Monika ; Mayer, Leonie ; Mykytyn, Anna Z ; Ly, My Linh ; Addo, Marylyn M ; Dahlke, Christine ; Renevier, Niclas ; Kaltenberg, Laura ; Klüver, Michael ; Sandkuhl, Maren ; Tscherne, Alina ; Gerresheim, Gesche K ; Weskamm, Leonie M ; Neubert, Andreas ; Borregaard, Saskia ; van Gorp, Eric C M ; Kupke, Alexandra ; Funk, Jana ; Zoran, Tamara ; Haagmans, Bart L ; Kalomidou, Georgia ; Becker, Stephan ; Schlesner, Claudia ; Schwamborn, Klaus ; Sutter, Gerd ; Kardinahl, Simone ; Mellinghoff, Sybille ; Dieck, Marie-Louise ; Kelidou, Anastasia ; Volz, Asisa ; Fathi, Anahita ; Hesterkamp, Thomas ; Friedrich, Monika ; Grüttner, Cordula ; Hardtke, Svenja ; Raadsen, Matthijs P ; Schröder, Simon

BACKGROUNDMERS-CoV is a respiratory pathogen with a case-fatality rate of 36%, and for which no vaccines are currently licensed. MVA-MERS-S is a candidate vaccine based on recombinant modified vaccinia virus Ankara (MVA). In this study, the safety, immunogenicity, and optimal dose schedule of MVA-MERS-S was assessed in individuals with previous exposure to SARS-CoV-2 infections and vaccines.METHODSWe conducted a multicentre, double-blind, randomised controlled phase 1b clinical trial at two university medical centres in Germany and the Netherlands. Healthy volunteers aged 18-55 years were assigned by computer randomisation to receive three intramuscular injections of 10⁷ or 10⁸ plaque-forming units (PFU) of MVA-MERS-S, with two treatment groups each of either 28-day or 56-day intervals between the initial two doses, and one control arm that received only placebo, at a ratio of 2:2:2:2:1. The third dose was given after 224 days. The sponsor, clinical and laboratory staff, and participants were masked to both vaccine dose and dosing interval. The primary outcome was safety, assessed in the all participants who had received at least one injection; daily solicited vaccine reactions were recorded after each dose for 7 days, unsolicited adverse events for 28 days, and serious adverse events throughout the study. The secondary outcome was humoral immunogenicity, measured with vaccine-induced geometric mean antibody concentrations and seroconversion rates, analysed in all participants who received at least three allocated treatments. This study is registered at ClinicalTrials.gov (NCT04119440) and is completed.FINDINGSBetween 26 July, 2021, and 3 March, 2022, 244 volunteers were screened, 177 of whom were eligible and 140 were randomly assigned either to the 28-day 10⁷ PFU group (n=32), 56-day 10⁷ PFU group (n=31), 28-day 10⁸ PFU group (n=31), 56-day 10⁸ PFU group (n=30), or placebo group (n=16). In total, 178 doses were administered of 10⁷ PFU of MVA-MERS-S, 174 of 10⁸ PFU, and 164 doses of placebo, and 139 participants received at least one injection. 73 (53%) were female and 66 (48%) were male. No serious vaccine-related adverse events occurred. Solicited local reactions were mild in 288 (93%, 95% CI 90-96) of 309 reports and consisted primarily of pain or tenderness. Pain or tenderness (of any severity) occurred after 69 (39%, 32-46) of 178 10⁷ PFU injections, 138 (79%; 73-85) of 174 10⁸ PFU injections, and 18 (11%; 7-11) of 164 placebo injections. Of 595 reported solicited systemic reactions, 479 (81%, 77-83) were graded as mild. Systemic reactions of any grade occurred after 77 (43%; 36-51) 10⁷ PFU injections, 102 (59%; 51-66) 10⁸ PFU injections, and 67 (41%; 34-49) of 164 placebo injections. At 28 days after the second dose, MERS-CoV neutralising antibodies were highest for participants assigned to 56-day 10⁸ PFU, with geometric mean ratios of 7·2 (95% CI 3·9-13·3) for the 56-day 10⁸ PFU group versus the 28-day 10⁸ PFU group (p<0·0001), 3·9 (2·1-7·2) for the 56-day 10⁸ PFU group versus the 56-day 10⁷ PFU group (p=0·0031), and 5·4 (2·9-10·0) for the 56-day 10⁸ PFU group versus the 28-day 10⁷ PFU group (p=0·0003).INTERPRETATIONMVA-MERS-S was safe and immunogenic in individuals with previous and concurrent SARS-CoV-2 exposure. The second vaccination with the 10⁸ PFU dose of MVA-MERS-S elicited a stronger humoral immune response when administered 56 days after the first dose than a 28-day interval. Further studies are needed to verify these findings in groups at risk for MERS-CoV exposure, and at risk of severe disease, including older individuals and those with relevant comorbidities.FUNDINGCoalition for Epidemic Preparedness Innovations, the German Centre for Infection Research, and the German Research Foundation.

2024-10-01·The Lancet Global Health

Modelling vaccination approaches for mpox containment and mitigation in the Democratic Republic of the Congo

Article

作者: Shaw, Souradet Y ; Rimoin, Anne W ; Savinkina, Alexandra ; Hoff, Nicole A ; Bogoch, Isaac I ; Mbala-Kingebeni, Placide ; Pitzer, Virginia E ; Gonsalves, Gregg S ; Kindrachuk, Jason

BACKGROUNDMpox was first identified in the Democratic Republic of the Congo (DRC) in 1970. In 2023, a historic outbreak of mpox occurred in the country, continuing into 2024. Over 14 000 cases and 600 deaths were reported in 2023 alone, representing a major increase from previous outbreaks. The modified vaccinia Ankara vaccine (brand names JYNNEOS, Imvamune, and Imvanex) was used in the 2022 mpox outbreak in the USA and Europe. However, at the time of the study, vaccination had not been made available in the DRC. We aimed to inform policy and decision makers on the potential benefits of, and resources needed, for mpox vaccination campaigns in the DRC by providing counterfactual scenarios evaluating the short-term effects of various vaccination strategies on mpox cases and deaths, if such a vaccination campaign had been undertaken before the 2023-24 outbreak.METHODSA dynamic transmission model was used to simulate mpox transmission in the DRC, stratified by age (<5, 5-15, and >15 years) and province. The model was used to simulate potential vaccination strategies, varying by age and region (endemic provinces, non-endemic provinces with historic cases, and all provinces) assessing the effect the strategies would have on deaths and cases in an epidemic year similar to 2023. In addition, we estimated the number of vaccine doses needed to implement each strategy.FINDINGSWithout vaccination, our model predicted 14 700 cases and 700 deaths from mpox over 365 days. Vaccinating 80% of all children younger than 5 years in endemic regions led to a 27% overall reduction in cases and a 43% reduction in deaths, requiring 10·5 million vaccine doses. Vaccinating 80% of all children younger than 5 years in all regions led to a 29% reduction in cases and a 43% reduction in deaths, requiring 33·1 million doses. Vaccinating 80% of children aged 15 years or younger in endemic provinces led to a 54% reduction in cases and a 71% reduction in deaths, requiring 26·6 million doses.INTERPRETATIONWhen resources are limited, vaccinating children aged 15 years or younger, or younger than 5 years, in endemic regions of the DRC would be the most efficient use of vaccines. Further research is needed to explore long-term effects of a one-time or recurrent vaccination campaign.FUNDINGCanadian Institutes of Health Research, Canadian International Development Research Centre, US Department of Defense (Defense Threat Reduction Agency, Mpox Threat Reduction Network), Global Affairs Canada (Weapons Threat Reduction Program), US Department for Agriculture (Agriculture Research Service, Non-Assistance Cooperative Agreement).

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床1期	-	The Aaron Diamond AIDS Research Center	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2011	临床1期	鼻咽癌	18	recombinant modified vaccinia ankara (MVA) vaccine (MVA-EL)	選淵鹽鹽壓窪鑰廠膚網(鏇構鹹齋簾蓋淵餘鏇艱) = 觸選鏇淵選範齋繭網糧積鬱願醖選繭願夢積網 (壓壓齋鹽衊範簾範簾醖 ) 更多	-	2011-05-20