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Article ; Online: Intradermal delivery of the third dose of the mRNA-1273 SARS-CoV-2 vaccine: safety and immunogenicity of a fractional booster dose.

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

2024

Abstract: Objectives: The aim of this study was to assess the safety and immunogenicity of a dose-sparing fractional intradermal (ID) booster strategy with the mRNA-1273 COVID-19 vaccine.: Methods: COVID-19 naive adults aged 18-30 years were recruited from a ... ...

Abstract	Objectives: The aim of this study was to assess the safety and immunogenicity of a dose-sparing fractional intradermal (ID) booster strategy with the mRNA-1273 COVID-19 vaccine. Methods: COVID-19 naive adults aged 18-30 years were recruited from a previous study on primary vaccination regimens that compared 20 μg ID vaccinations with 100 μg intramuscular (IM) vaccinations with mRNA-1273 as the primary vaccination series. Participants previously immunized with ID regimens were randomly assigned (1:1) to receive a fractional ID booster dose (20 μg) or the standard-of-care intramuscular (IM) booster dose (50 μg) of the mRNA-1273 vaccine, 6 months after completing their primary series (ID-ID and ID-IM group, respectively). Participants that had received a full dose IM regimen as the primary series, received the IM standard-of-care booster dose (IM-IM group). In addition, COVID-19 naive individuals aged 18-40 years who had received an IM mRNA vaccine as the primary series were recruited from the general population to receive a fractional ID booster dose (IM-ID group). Immunogenicity was assessed using IgG anti-spike antibody responses and neutralizing capacity against SARS-CoV-2. Cellular immune responses were measured in a sub-group. Safety and tolerability were monitored. Results: In January 2022, 129 participants were included in the study. Fractional ID boosting was safe and well tolerated, with fewer systemic adverse events compared with IM boosting. At day 28 post-booster, anti-spike S1 IgG geometric mean concentrations were 9106 (95% CI, 7150-11 597) binding antibody units (BAU)/mL in the IM-IM group and 4357 (3003-6322) BAU/mL; 6629 (4913-8946) BAU/mL; and 5264 (4032-6873) BAU/mL in the ID-IM, ID-ID, and IM-ID groups, respectively. Discussion: Intradermal boosting provides robust immune responses and is a viable dose-sparing strategy for mRNA COVID-19 vaccines. The favourable side-effect profile supports its potential to reduce vaccine hesitancy. Fractional dosing strategies should be considered early in the clinical development of future mRNA vaccines to enhance vaccine availability and pandemic preparedness.
Language	English
Publishing date	2024-03-28
Publishing country	England
Document type	Journal Article
ZDB-ID	1328418-6
ISSN	1469-0691 ; 1470-9465 ; 1198-743X
ISSN (online)	1469-0691
ISSN	1470-9465 ; 1198-743X
DOI	10.1016/j.cmi.2024.03.028
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Article: Urinary Metabolic Profiling in Volunteers Undergoing Malaria Challenge in Gabon.

Betouke Ongwe, Madeleine Eunice / Kohler, Isabelle / Manurung, Mikhael D / Verhoeven, Aswin / Derks, Rico / Janse, Jacqueline J / Mouwenda, Yoanne D / Kremsner, Peter G / Adegnika, Ayola A / Lell, Bertrand / Everts, Bart / Mayboroda, Oleg A / Yazdanbakhsh, Maria

Metabolites

2022 Volume 12, Issue 12

Abstract: The interaction of malaria parasites with their human host is extensively studied, yet only few studies reported ... ...

Abstract	The interaction of malaria parasites with their human host is extensively studied, yet only few studies reported how
Language	English
Publishing date	2022-12-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662251-8
ISSN	2218-1989
ISSN	2218-1989
DOI	10.3390/metabo12121224
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Article ; Online: Immunogenicity and reactogenicity of intradermal mRNA-1273 SARS-CoV-2 vaccination: a non-inferiority, randomized-controlled trial.

Prins, Manon L M / Roozen, Geert V T / Pothast, Cilia R / Huisman, Wesley / van Binnendijk, Rob / den Hartog, Gerco / Kuiper, Vincent P / Prins, Corine / Janse, Jacqueline J / Lamers, Olivia A C / Koopman, Jan Pieter R / Kruithof, Annelieke C / Kamerling, Ingrid M C / Dijkland, Romy C / de Kroon, Alicia C / Azimi, Shohreh / Feltkamp, Mariet C W / Kuijer, Marjan / Jochems, Simon P /

Heemskerk, Mirjam H M / Rosendaal, Frits R / Roestenberg, Meta / Visser, Leo G / Roukens, Anna H E

NPJ vaccines

2024 Volume 9, Issue 1, Page(s) 1

Abstract: Fractional dosing can be a cost-effective vaccination strategy to accelerate individual and herd immunity in a pandemic. We assessed the immunogenicity and safety of primary intradermal (ID) vaccination, with a 1/5th dose compared with the standard ... ...

Abstract	Fractional dosing can be a cost-effective vaccination strategy to accelerate individual and herd immunity in a pandemic. We assessed the immunogenicity and safety of primary intradermal (ID) vaccination, with a 1/5th dose compared with the standard intramuscular (IM) dose of mRNA-1273 in SARS-CoV-2 naïve persons. We conducted an open-label, non-inferiority, randomized controlled trial in the Netherlands between June and December 2021. One hundred and fifty healthy and SARS-CoV-2 naïve participants, aged 18-30 years, were randomized (1:1:1) to receive either two doses of 20 µg mRNA-1273 ID with a standard needle (SN) or the Bella-mu® needle (BM), or two doses of 100 µg IM, 28 days apart. The primary outcome was non-inferiority in seroconversion rates at day 43 (D43), defined as a neutralizing antibody concentration threshold of 465 IU/mL, the lowest response in the IM group. The non-inferiority margin was set at -15%. Neutralizing antibody concentrations at D43 were 1789 (95% CI: 1488-2150) in the IM and 1263 (951-1676) and 1295 (1020-1645) in the ID-SN and ID-BM groups, respectively. The absolute difference in seroconversion proportion between fractional and standard-dose groups was -13.95% (-24.31 to -3.60) for the ID-SN and -13.04% (-22.78 to -3.31) for the ID-BM group and exceeded the predefined non-inferiority margin. Although ID vaccination with 1/5th dose of mRNA-1273 did not meet the predefined non-inferior criteria, the neutralizing antibody concentrations in these groups are far above the proposed proxy for protection against severe disease (100 IU/mL), justifying this strategy in times of vaccine scarcity to accelerate mass protection against severe disease.
Language	English
Publishing date	2024-01-02
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-023-00785-w
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Article ; Online: Katayama Syndrome Without Schistosoma mansoni Eggs.

Langenberg, Marijke C C / Hoogerwerf, Marie-Astrid / Janse, Jacqueline J / van Lieshout, Lisette / Corstjens, Paul L A M / Roestenberg, Meta

Annals of internal medicine

2019 Volume 170, Issue 10, Page(s) 732–733

MeSH term(s)	Adult ; Animals ; Cercaria/pathogenicity ; Female ; Humans ; Schistosoma mansoni/pathogenicity ; Schistosomiasis/diagnosis ; Schistosomiasis/therapy ; Serologic Tests ; Syndrome ; Young Adult
Language	English
Publishing date	2019-01-08
Publishing country	United States
Document type	Case Reports ; Letter
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/L18-0438
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Article ; Online: Safety and Immunogenicity of Intradermal Fractional Dose Administration of the mRNA-1273 Vaccine: A Proof-of-Concept Study.

Roozen, Geert V T / Prins, Margaretha L M / van Binnendijk, Rob / den Hartog, Gerco / Kuiper, Vincent P / Prins, Corine / Janse, Jacqueline J / Kruithof, Annelieke C / Feltkamp, Mariet C W / Kuijer, Marjan / Rosendaal, Frits R / Roestenberg, Meta / Visser, Leo G / Roukens, Anna H E

Annals of internal medicine

2022

Language	English
Publishing date	2022-10-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M22-2089
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Article ; Online: Protective efficacy of short-term infection with Necator americanus hookworm larvae in healthy volunteers in the Netherlands: a single-centre, placebo-controlled, randomised, controlled, phase 1 trial.

Hoogerwerf, Marie-Astrid / Janse, Jacqueline J / Kuiper, Vincent P / van Schuijlenburg, Roos / Kruize, Yvonne Cm / Sijtsma, Jeroen C / Nosoh, Beckley A / Koopman, Jan-Pieter R / Verbeek-Menken, Petra H / Westra, Inge M / Meij, Pauline / Brienen, Eric At / Visser, Leo G / van Lieshout, Lisette / Jochems, Simon P / Yazdanbakhsh, Maria / Roestenberg, Meta

The Lancet. Microbe

2023 Volume 4, Issue 12, Page(s) e1024–e1034

Abstract: Background: Vaccine development against hookworm is hampered by the absence of the development of protective immunity in populations repeatedly exposed to hookworm, limiting identification of mechanisms of protective immunity and new vaccine targets. ... ...

Abstract	Background: Vaccine development against hookworm is hampered by the absence of the development of protective immunity in populations repeatedly exposed to hookworm, limiting identification of mechanisms of protective immunity and new vaccine targets. Immunisation with attenuated larvae has proven effective in dogs and partial immunity has been achieved using an irradiated larvae model in healthy volunteers. We aimed to investigate the protective efficacy of immunisation with short-term larval infection against hookworm challenge. Methods: We did a single-centre, placebo-controlled, randomised, controlled, phase 1 trial at Leiden University Medical Center (Leiden, Netherlands). Healthy volunteers (aged 18-45 years) were recruited using advertisements on social media and in publicly accessible areas. Volunteers were randomly assigned (2:1) to receive three short-term infections with 50 infectious Necator americanus third-stage filariform larvae (50L3) or placebo. Infection was abrogated with a 3-day course of albendazole 400 mg, 2 weeks after each exposure. Subsequently all volunteers were challenged with two doses of 50L3 at a 2-week interval. The primary endpoint was egg load (geometric mean per g faeces) measured weekly between weeks 12 and 16 after first challenge, assessed in the per-protocol population, which included all randomly assigned volunteers with available data on egg counts at week 12-16 after challenge. This study is registered with ClinicalTrials.gov, NCT03702530. Findings: Between Nov 8 and Dec 14, 2018, 26 volunteers were screened, of whom 23 enrolled in the trial. The first immunisation was conducted on Dec 18, 2018. 23 volunteers were randomly assigned (15 to the intervention group and eight to the placebo group). Egg load after challenge was lower in the intervention group than the placebo group (geometric mean 571 eggs per g [range 372-992] vs 873 eggs per g [268-1484]); however, this difference was not statistically significant (p=0·10). Five volunteers in the intervention group developed a severe skin rash, which was associated with 40% reduction in egg counts after challenge (geometric mean 742 eggs per g [range 268-1484] vs 441 eggs per g [range 380-520] after challenge; p=0·0025) and associated with higher peak IgG1 titres. Interpretation: To our knowledge, this is the first study to describe a protective effect of short-term exposure to hookworm larvae and show an association with skin response, eosinophilic response, and IgG1. These findings could inform future hookworm vaccine development. Funding: Dioraphte Foundation.
MeSH term(s)	Humans ; Animals ; Dogs ; Necator americanus ; Healthy Volunteers ; Netherlands ; Hookworm Infections/drug therapy ; Hookworm Infections/prevention & control ; Immunoglobulin G ; Larva
Chemical Substances	Immunoglobulin G
Language	English
Publishing date	2023-12-02
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2666-5247
ISSN (online)	2666-5247
DOI	10.1016/S2666-5247(23)00218-5
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Article ; Online: Screening of a Library of Recombinant Schistosoma mansoni Proteins With Sera From Murine and Human Controlled Infections Identifies Early Serological Markers.

Crosnier, Cécile / Hokke, Cornelis H / Protasio, Anna V / Brandt, Cordelia / Rinaldi, Gabriel / Langenberg, Marijke C C / Clare, Simon / Janse, Jacqueline J / Wilson, Shona / Berriman, Matthew / Roestenberg, Meta / Wright, Gavin J

The Journal of infectious diseases

2020 Volume 225, Issue 8, Page(s) 1435–1446

Abstract: Background: Schistosomiasis is a major global health problem caused by blood-dwelling parasitic worms, which is currently tackled primarily by mass administration of the drug praziquantel. Appropriate drug treatment strategies are informed by ... ...

Abstract	Background: Schistosomiasis is a major global health problem caused by blood-dwelling parasitic worms, which is currently tackled primarily by mass administration of the drug praziquantel. Appropriate drug treatment strategies are informed by diagnostics that establish the prevalence and intensity of infection, which, in regions of low transmission, should be highly sensitive. Methods: To identify sensitive new serological markers of Schistosoma mansoni infections, we have compiled a recombinant protein library of parasite cell-surface and secreted proteins expressed in mammalian cells. Results: Together with a time series of sera samples from volunteers experimentally infected with a defined number of male parasites, we probed this protein library to identify several markers that can detect primary infections with as low as 10 parasites and as early as 5 weeks postinfection. Conclusions: These new markers could be further explored as valuable tools to detect ongoing and previous S mansoni infections, including in endemic regions where transmission is low.
MeSH term(s)	Animals ; Biomarkers ; Humans ; Male ; Mammals ; Mice ; Praziquantel/therapeutic use ; Recombinant Proteins ; Schistosoma mansoni ; Schistosomiasis/drug therapy ; Schistosomiasis mansoni/diagnosis ; Schistosomiasis mansoni/drug therapy ; Schistosomiasis mansoni/parasitology
Chemical Substances	Biomarkers ; Recombinant Proteins ; Praziquantel (6490C9U457)
Language	English
Publishing date	2020-05-29
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiaa329
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Article ; Online: Safety and infectivity of female cercariae in Schistosoma-naïve, healthy participants: a controlled human Schistosoma mansoni infection study.

Koopman, Jan Pieter R / Houlder, Emma L / Janse, Jacqueline J / Casacuberta-Partal, Miriam / Lamers, Olivia A C / Sijtsma, Jeroen C / de Dood, Claudia / Hilt, Stan T / Ozir-Fazalalikhan, Arifa / Kuiper, Vincent P / Roozen, Geert V T / de Bes-Roeleveld, Laura M / Kruize, Yvonne C M / Wammes, Linda J / Smits, Hermelijn H / van Lieshout, Lisette / van Dam, Govert J / van Amerongen-Westra, Inge M / Meij, Pauline /

Corstjens, Paul L A M / Jochems, Simon P / van Diepen, Angela / Yazdanbakhsh, Maria / Hokke, Cornelis H / Roestenberg, Meta

EBioMedicine

2023 Volume 97, Page(s) 104832

Abstract: Background: A controlled human infection model for schistosomiasis (CHI-S) can speed up vaccine development and provides insight into early immune responses following schistosome exposure. Recently, we established CHI-S model using single-sex male-only ... ...

Abstract	Background: A controlled human infection model for schistosomiasis (CHI-S) can speed up vaccine development and provides insight into early immune responses following schistosome exposure. Recently, we established CHI-S model using single-sex male-only Schistosoma mansoni (Sm) cercariae in Schistosoma-naïve individuals. Given important differences in antigenic profile and human immune responses to schistosomes of different sex, we pioneered a single-sex female-only CHI-S model for future use in vaccine development. Methods: We exposed 13 healthy, Schistosoma-naïve adult participants to 10 (n = 3) or 20 (n = 10) female cercariae and followed for 20 weeks, receiving treatment with praziquantel (PZQ) 60 mg/kg at week 8 and 12 after exposure. Findings: The majority (11/13) participants reported rash and/or itch at the site of exposure, 5/13 had transient symptoms of acute schistosomiasis. Exposure to 20 cercariae led to detectable infection, defined as serum circulating anodic antigen levels >1.0 pg/mL, in 6/10 participants. Despite two rounds of PZQ treatment, 4/13 participants showed signs of persistent infection. Additional one- or three-day PZQ treatment (1 × 60 mg/kg and 3 × 60 mg/kg) or artemether did not result in cure, but over time three participants self-cured. Antibody, cellular, and cytokine responses peaked at week 4 post infection, with a mixed Th1, Th2, and regulatory profile. Cellular responses were (most) discriminative for symptoms. Interpretation: Female-only infections exhibit similar clinical and immunological profiles as male-only infections but are more resistant to PZQ treatment. This limits future use of this model and may have important implications for disease control programs. Funding: European Union's Horizon 2020 (grant no. 81564).
MeSH term(s)	Adult ; Animals ; Humans ; Male ; Female ; Schistosomiasis mansoni/drug therapy ; Healthy Volunteers ; Schistosoma mansoni ; Praziquantel/pharmacology ; Praziquantel/therapeutic use ; Cytokines ; Anthelmintics/pharmacology ; Anthelmintics/therapeutic use
Chemical Substances	Praziquantel (6490C9U457) ; Cytokines ; Anthelmintics
Language	English
Publishing date	2023-10-12
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2023.104832
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Article ; Online: Schistosoma haematobium infection is associated with lower serum cholesterol levels and improved lipid profile in overweight/obese individuals.

Zinsou, Jeannot F / Janse, Jacqueline J / Honpkehedji, Yabo Y / Dejon-Agobé, Jean Claude / García-Tardón, Noemí / Hoekstra, Pytsje T / Massinga-Loembe, Marguerite / Corstjens, Paul L A M / van Dam, Govert J / Giera, Martin / Kremsner, Peter G / Yazdanbakhsh, Maria / Adegnika, Ayola A / Guigas, Bruno

PLoS neglected tropical diseases

2020 Volume 14, Issue 7, Page(s) e0008464

Abstract: Infection with parasitic helminths has been reported to improve insulin sensitivity and glucose homeostasis, lowering the risk for type 2 diabetes. However, little is known about its impact on whole-body lipid homeostasis, especially in obese individuals. ...

Abstract	Infection with parasitic helminths has been reported to improve insulin sensitivity and glucose homeostasis, lowering the risk for type 2 diabetes. However, little is known about its impact on whole-body lipid homeostasis, especially in obese individuals. For this purpose, a cross-sectional study was carried out in lean and overweight/obese adults residing in the Lambaréné region of Gabon, an area endemic for Schistosoma haematobium. Helminth infection status, peripheral blood immune cell counts, and serum metabolic and lipid/lipoprotein levels were analyzed. We found that urine S. haematobium egg-positive individuals exhibited lower serum total cholesterol (TC; 4.42 vs 4.01 mmol/L, adjusted mean difference [95%CI] -0.30 [-0.68,-0.06]; P = 0.109), high-density lipoprotein (HDL)-C (1.44 vs 1.12 mmol/L, -0.24 [-0.43,-0.06]; P = 0.009) and triglyceride (TG; 0.93 vs 0.72 mmol/L, -0.20 [-0.39,-0.03]; P = 0.022) levels than egg-negative individuals. However, when stratified according to body mass index, these effects were only observed in overweight/obese infected individuals. Similarly, significant negative correlations between the intensity of infection, assessed by serum circulating anodic antigen (CAA) concentrations, and TC (r = -0.555; P<0.001), HDL-C (r = -0.327; P = 0.068), LDL-C (r = -0.396; P = 0.025) and TG (r = -0.381; P = 0.032) levels were found in overweight/obese individuals but not in lean subjects. Quantitative lipidomic analysis showed that circulating levels of some lipid species associated with cholesterol-rich lipoprotein particles were also significantly reduced in overweight/obese infected individuals in an intensity-dependent manner. In conclusion, we reported that infection with S. haematobium is associated with improved lipid profile in overweight/obese individuals, a feature that might contribute reducing the risk of cardiometabolic diseases in such population.
MeSH term(s)	Adolescent ; Adult ; Cholesterol/blood ; Female ; Humans ; Insulin Resistance ; Lipids/blood ; Male ; Middle Aged ; Obesity/metabolism ; Overweight/metabolism ; Schistosomiasis haematobia/metabolism ; Young Adult
Chemical Substances	Lipids ; Cholesterol (97C5T2UQ7J)
Language	English
Publishing date	2020-07-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2429704-5
ISSN	1935-2735 ; 1935-2727
ISSN (online)	1935-2735
ISSN	1935-2727
DOI	10.1371/journal.pntd.0008464
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Article ; Online: Tolerability, safety and immunogenicity of intradermal delivery of a fractional dose mRNA -1273 SARS-CoV-2 vaccine in healthy adults as a dose sparing strategy

Roozen, Geert V.T. / Prins, Manon / van Binnendijk, Rob / den, Gerco / Kuiper, Vincent / Prins, Corine / Janse, Jacqueline J / Kruithof, Annelieke C / Feltkamp, Mariet C.W. / Kuijer, Marjan / Roosendaal, Frits R / Roestenberg, Meta / Visser, Leo G / Roukens, Anna H.E.

medRxiv

Abstract: Background There is an urgent need for fair and equitable access to safe and effective vaccines to end the COVID-19 pandemic. Shortages in reagents and vaccines are a major challenge, as well as limited knowledge on dose response relationship with mRNA ... ...

Abstract	Background There is an urgent need for fair and equitable access to safe and effective vaccines to end the COVID-19 pandemic. Shortages in reagents and vaccines are a major challenge, as well as limited knowledge on dose response relationship with mRNA COVID-19 vaccines. We explored intradermal fractional dose administration of a mRNA SARS-CoV-2/COVID-19 vaccine as a potential dose-sparing strategy. Methods We conducted a proof-of-concept, dose-escalation, open-label, randomised-controlled vaccine trial (IDSCOVA) in healthy adults aged 18-30 years. To test initial safety, ten participants received 10 μg mRNA-1273 vaccine through intradermal injection at day 1 and 29. Following a favourable safety review, thirty participants were 1:1 randomised to receive 20 μg mRNA-1273 either intradermally or intramuscularly. The primary endpoint was tolerability and safety. The secondary endpoint was seroconversion and specific IgG concentration against SARS-CoV-2 spike S1 and Receptor Binding Domain (RBD) after the second dose at day 43. We compared results to two historical cohorts of non-hospitalised COVID-19 patients and vaccinated individuals. Findings Thirty-eight of forty included participants (median age 25 years) completed the study. There were no serious adverse events. Self-reported local adverse reactions after intradermal delivery were mild, both in the 10 μg and the 20 μg group. In the higher dose group, systemic adverse reactions were more common, but still well tolerated. All 38 participants mounted substantially higher IgG-anti-S1 and IgG-anti-RBD concentrations at day 43 than COVID-19 controls. At day 43, anti-S1 (95% CI) was 1,696 (1,309-2,198) BAU/mL for the 10 μg intradermal group, 1,406 (953.5-2,074) BAU/mL for the 20 μg intramuscular group and 2,057 (1,421-2,975) BAU/mL for the 20 μg intradermal group. Anti-S1 was 107.2 (63-182.2) BAU/mL for the convalescent plasma control group and 1,558 (547.8-4,433) BAU/mL for the individuals vaccinated with 100 μg mRNA-1273. Interpretation Intradermal administration of 10 μg and 20 μg mRNA-1273 vaccine was well tolerated and safe, and resulted in a robust antibody response. Intradermal vaccination has the potential to be deployed for vaccine dose-sparing.
Keywords	covid19
Language	English
Publishing date	2021-07-28
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.07.27.21261116
Database	COVID19

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