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Book ; Thesis: Klinisch-epidemiologische Untersuchung zu Vergiftungen mit ätherischen Ölen und Duftölen

Baehner, Frank

2001

Author's details	vorgelegt von Frank André Bähner
Language	German
Size	64 Bl., graph. Darst.
Edition	[Mikrofiche-Ausg.]
Publishing country	Germany
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Mainz, Univ., Diss., 2001
HBZ-ID	HT013295121
Database	Catalogue ZB MED Medicine, Health

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Article: Spesolimab Efficacy and Safety in Patients with Moderate-to-Severe Palmoplantar Pustulosis: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Phase IIb, Dose-Finding Study.

Burden, A David / Bissonnette, Robert / Navarini, Alexander A / Murakami, Masamoto / Morita, Akimichi / Haeufel, Thomas / Ye, Binqi / Baehner, Frank / Terui, Tadashi

Dermatology and therapy

2023 Volume 13, Issue 10, Page(s) 2279–2297

Abstract: Introduction: We evaluated the anti-interleukin-36 receptor antibody spesolimab in patients with moderate-to-severe palmoplantar pustulosis (PPP).: Methods: This phase IIb trial comprised a loading dose period to week (W) 4, then maintenance dosing ... ...

Abstract	Introduction: We evaluated the anti-interleukin-36 receptor antibody spesolimab in patients with moderate-to-severe palmoplantar pustulosis (PPP). Methods: This phase IIb trial comprised a loading dose period to week (W) 4, then maintenance dosing to W52. Patients were randomised 2:1:1:1:2 to subcutaneous spesolimab 3000 mg to W4 then 600 mg every 4 weeks (q4w), spesolimab 3000 mg to W4 then 300 mg q4w, spesolimab 1500 mg to W4 then 600 mg q4w, spesolimab 1500 mg to W4, 300 mg q4w to W16 then 300 mg every 8 weeks (q8w), or placebo switching to spesolimab 600 mg q4w at W16. The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPP ASI) at W16. Secondary endpoints included a Palmoplantar Pustular Physician's Global Assessment (PPP PGA) score of 0/1. Safety (including adverse events [AEs], local tolerability) was assessed. Results: 152 patients were treated. The primary endpoint was not met; mean differences for spesolimab versus placebo ranged from - 14.6% (95% confidence interval [CI]: - 31.5%, 2.2%) to - 5.3% (95% CI: - 19.1%, 8.6%); none reached significance. At W16, 23 (21.1%) and two (4.7%) patients in the combined spesolimab and placebo groups, respectively, achieved PPP PGA 0/1 (mean difference 16.4%; 95% CI: 3.8%, 25.7%), increasing to 59 (54.1%; combined spesolimab) and 12 (27.9%; placebo switch to spesolimab) patients at W52. Non-Asian patients had significant improvements in the primary endpoint (mean difference - 17.7%; nominal P = 0.0394) and PPP PGA 0/1 at W16 with spesolimab versus placebo. Rates of AEs and AE-related discontinuations were similar for spesolimab and placebo. Local tolerability events and injection-site reactions were more frequent with spesolimab than placebo. Conclusion: The primary objective to demonstrate a non-flat dose-response relationship and proof-of-concept was not achieved; improvements with spesolimab occurred in secondary endpoints and in non-Asian patients, indicating potential modest benefits. Spesolimab was generally well tolerated (ClinicalTrials.gov NCT04015518).
Language	English
Publishing date	2023-09-20
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2680284-3
ISSN	2190-9172 ; 2193-8210
ISSN (online)	2190-9172
ISSN	2193-8210
DOI	10.1007/s13555-023-01002-1
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Article: Immunogenicity of a bivalent virus-like particle norovirus vaccine in children from 1 to 8 years of age: A phase 2 randomized, double-blind study

Vesikari, Timo / Saez-Llorens, Xavier / Blazevic, Vezna / Lopez, Pio / Lopez, Eduardo / Masuda, Taisei / Mendelman, Paul M. / Liu, Mengya / Sherwood, James / Baehner, Frank / Borkowski, Astrid

Vaccine. 2022 June 09, v. 40, no. 26

2022

Abstract: Young children can suffer severe consequences of norovirus gastroenteritis. We performed a dose-finding study of a bivalent virus-like particle (VLP) vaccine candidate (TAK-214) in healthy 1–8-year-old children. In this phase 2 study two age cohorts (1–3 ...

Abstract	Young children can suffer severe consequences of norovirus gastroenteritis. We performed a dose-finding study of a bivalent virus-like particle (VLP) vaccine candidate (TAK-214) in healthy 1–8-year-old children. In this phase 2 study two age cohorts (1–3 and 4–8 years of age inclusive, N = 120 per cohort) of children enrolled from Finland, Panama and Colombia were initially randomized 1:1:1:1 to four groups which were further split into two equal subgroups, to receive one or two intramuscular doses of four TAK-214 formulations containing 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)₃ at 28 days interval. ELISA Pan-Ig and histoblood group antigen-blocking (HBGA) antibodies against each VLP were measured on days 1, 29, 57 and 210. Parents/guardians recorded solicited local and systemic adverse events (AE) and any unsolicited or serious AEs (SAE). All formulations were well-tolerated across both age cohorts and dosage groups with no vaccine-related SAEs reported. Solicited AEs were mostly mild-to-moderate, resolved quickly, and did not increase after the second dose. Pan-Ig and HBGA responses induced after one dose were only slightly increased by the second dose. Across dose groups at Day 29 after one dose GI.1 Pan Ig seroresponse rates (SRR) were 82–97% and 81–96% and GII.4c SRR were 79–97% and 80–91% in 1–3 and 4–8 year-olds, respectively. Respective rates were to 92–93% and 73–92% for GI.1, and 77–100% and 62–83% for GII.4c at Day 57 following two doses. HBGA responses had similar profiles. Both Pan Ig and HBGA geometric mean titers persisted above baseline up to Day 210. All dosages of TAK-214 displayed acceptable reactogenicity in 1–8-year-old children and induced robust, durable immune responses after one dose which are further increased after two doses.
Keywords	gastroenteritis ; genotype ; immunogenicity ; vaccines ; Colombia ; Finland ; Panama
Language	English
Dates of publication	2022-0609
Size	p. 3588-3596.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.04.089
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Understanding potential participation barriers to improve trial design and outcomes: clinical trial simulation in palmoplantar pustulosis as a case study.

Boisvert-Huneault, Christian / Trigos Herraez, David / Pinter, Andreas / Kobayashi, Satomi / Bell, Stacie / Kallsen, Kimberley / Gloede, Tristan / Yagi, Nobutaka / Brunette, Steven / Datsenko, Yakov / Baehner, Frank / Clerisme-Beaty, Emmanuelle / Van de Kerkhof, Peter

BMJ open

2023 Volume 13, Issue 4, Page(s) e064159

Abstract: Objectives: Evaluate the experiences and perceptions of patients participating in a simulated clinical trial and identify ways to enhance future patient-centric trial designs.: Design: International, multicentre, non-interventional, virtual clinical ... ...

Abstract	Objectives: Evaluate the experiences and perceptions of patients participating in a simulated clinical trial and identify ways to enhance future patient-centric trial designs. Design: International, multicentre, non-interventional, virtual clinical trial visits with patient debriefs and advisory boards. Setting: Virtual clinic visits and accompanying advisory boards. Participants: Nine patients with palmoplantar pustulosis for simulated trial visits; 14 patients and patient representatives for advisory boards. Main outcome measures: Qualitative responses to trial documentation, visit schedule and logistics, and trial design were collected during patient debriefs. Results were discussed at two virtual advisory board meetings. Results: Patients identified key barriers to participation and potential difficulties encountered when attending trial visits and completing assessments. They also proposed recommendations to overcome these challenges. Patients recognised the need for comprehensive informed consent forms, but recommended use of non-technical language, brevity and additional support to aid understanding. Other trial documentations should be relevant to the disease and include known efficacy and safety of the study drug. Patients were concerned about receiving placebo, stopping existing medications and being unable to receive the study drug after trial completion; therefore, patients and physicians recommended an open-label extension following trial completion. Trial visits were too numerous (n=20) and too long (3-4 hours each); patients recommended improvements to the design to make best use of their time and reduce unnecessary waiting. They also requested financial and logistical support. Patients expressed a desire for study outcomes that matter to them, related to their ability to undertake normal daily activities and not be a burden to others. Conclusions: Simulated trials are an innovative method for assessing trial design and acceptance from a patient-centric perspective, enabling specific improvements to be made prior to trial initiation. Incorporation of recommendations from simulated trials could enhance trial recruitment and retention, and optimise trial outcomes and data quality.
Language	English
Publishing date	2023-04-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-064159
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Article ; Online: Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial.

López, Pio / López-Medina, Eduardo / Sáez-Llorens, Xavier / deAntonio, Rodrigo / Masuda, Taisei / Mendelman, Paul M / Sherwood, James / Baehner, Frank / Borkowski, Astrid

Human vaccines & immunotherapeutics

2023 Volume 19, Issue 1, Page(s) 2204787

Abstract: We conducted a dose-finding phase 2 study of the HilleVax bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in two cohorts of children, 6-≤12 months and 1-≤4 years of age (N = 120 per cohort), in Panama and Colombia (ClinicalTrials.gov, ... ...

Abstract	We conducted a dose-finding phase 2 study of the HilleVax bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in two cohorts of children, 6-≤12 months and 1-≤4 years of age (N = 120 per cohort), in Panama and Colombia (ClinicalTrials.gov, identifier NCT02153112). On Day 1, children randomized to one of the four equal groups received intramuscular injections of four different HIL-214 formulations containing 15/15, 15/50, 50/50, or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)
MeSH term(s)	Child, Preschool ; Humans ; Infant ; Antibodies, Viral ; Double-Blind Method ; Immunogenicity, Vaccine ; Injections, Intramuscular ; Norovirus ; Vaccines, Virus-Like Particle
Chemical Substances	Antibodies, Viral ; Vaccines, Virus-Like Particle
Language	English
Publishing date	2023-05-04
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2023.2204787
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Article: A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose

Treanor, John / Sherwood, Jim / Cramer, Jakob P / Le Cam Bouveret, Nancy / Lin, Stella / Baehner, Frank / Borkowski, Astrid

Vaccine. 2020 Aug. 10, v. 38, no. 36

2020

Abstract: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without ... ...

Institution	the NOR-204 investigators
Abstract	Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population.In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18–49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH)₃, with or without 15 μg MPL. We measured histo-blood group antigen blocking (HBGA) antibodies and ELISA Ig at Days 1, 8, 29, 57, 211 and 393, and avidity indices and cell-mediated immunity (CMI). Solicited local and systemic adverse events (AE) were assessed for 7 days and unsolicited AEs for 28 days after each injection.After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18–49, 60–74, 75–84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue.Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.
Keywords	adjuvants ; antigens ; cell-mediated immunity ; death ; gastroenteritis ; immunogenicity ; injection site ; lipid A ; morbidity ; pain ; placebos ; vaccination ; virus-like particle vaccines
Language	English
Dates of publication	2020-0810
Size	p. 5842-5850.
Publishing place	Elsevier Ltd
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.06.011
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Immunogenicity of a bivalent virus-like particle norovirus vaccine in children from 1 to 8 years of age: A phase 2 randomized, double-blind study.

Vesikari, Timo / Saez-Llorens, Xavier / Blazevic, Vezna / Lopez, Pio / Lopez, Eduardo / Masuda, Taisei / Mendelman, Paul M / Liu, Mengya / Sherwood, James / Baehner, Frank / Borkowski, Astrid

Vaccine

2022 Volume 40, Issue 26, Page(s) 3588–3596

Abstract: Background: Young children can suffer severe consequences of norovirus gastroenteritis. We performed a dose-finding study of a bivalent virus-like particle (VLP) vaccine candidate (TAK-214) in healthy 1-8-year-old children.: Methods: In this phase 2 ... ...

Abstract	Background: Young children can suffer severe consequences of norovirus gastroenteritis. We performed a dose-finding study of a bivalent virus-like particle (VLP) vaccine candidate (TAK-214) in healthy 1-8-year-old children. Methods: In this phase 2 study two age cohorts (1-3 and 4-8 years of age inclusive, N = 120 per cohort) of children enrolled from Finland, Panama and Colombia were initially randomized 1:1:1:1 to four groups which were further split into two equal subgroups, to receive one or two intramuscular doses of four TAK-214 formulations containing 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH) Results: All formulations were well-tolerated across both age cohorts and dosage groups with no vaccine-related SAEs reported. Solicited AEs were mostly mild-to-moderate, resolved quickly, and did not increase after the second dose. Pan-Ig and HBGA responses induced after one dose were only slightly increased by the second dose. Across dose groups at Day 29 after one dose GI.1 Pan Ig seroresponse rates (SRR) were 82-97% and 81-96% and GII.4c SRR were 79-97% and 80-91% in 1-3 and 4-8 year-olds, respectively. Respective rates were to 92-93% and 73-92% for GI.1, and 77-100% and 62-83% for GII.4c at Day 57 following two doses. HBGA responses had similar profiles. Both Pan Ig and HBGA geometric mean titers persisted above baseline up to Day 210. Conclusions: All dosages of TAK-214 displayed acceptable reactogenicity in 1-8-year-old children and induced robust, durable immune responses after one dose which are further increased after two doses.
MeSH term(s)	Antibodies, Viral ; Caliciviridae Infections/prevention & control ; Child ; Child, Preschool ; Double-Blind Method ; Humans ; Immunogenicity, Vaccine ; Infant ; Norovirus ; Vaccines, Virus-Like Particle ; Viral Vaccines
Chemical Substances	Antibodies, Viral ; Vaccines, Virus-Like Particle ; Viral Vaccines
Language	English
Publishing date	2022-05-17
Publishing country	Netherlands
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.04.089
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Article ; Online: A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose.

Treanor, John / Sherwood, Jim / Cramer, Jakob P / Le Cam Bouveret, Nancy / Lin, Stella / Baehner, Frank / Borkowski, Astrid

Vaccine

2020 Volume 38, Issue 36, Page(s) 5842–5850

Abstract: Introduction: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and ... ...

Abstract	Introduction: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population. Methods: In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18-49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH) Results: After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18-49, 60-74, 75-84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue. Conclusions: Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.
MeSH term(s)	Aged ; Aged, 80 and over ; Antibodies, Viral ; Double-Blind Method ; Gastroenteritis ; Humans ; Lipid A/analogs & derivatives ; Middle Aged ; Norovirus ; Receptors, Thrombopoietin ; Vaccines, Virus-Like Particle
Chemical Substances	Antibodies, Viral ; Lipid A ; Receptors, Thrombopoietin ; Vaccines, Virus-Like Particle ; MPL protein, human (143641-95-6) ; monophosphoryl lipid A (MWC0ET1L2P)
Language	English
Publishing date	2020-06-17
Publishing country	Netherlands
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.06.011
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Article ; Online: An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults.

Atmar, Robert L / Cramer, Jakob P / Baehner, Frank / Han, Cong / Borkowski, Astrid / Mendelman, Paul M

The Journal of infectious diseases

2018 Volume 219, Issue 3, Page(s) 410–414

Abstract: As noroviruses are transmitted through the fecal-oral route, we investigated humoral and mucosal (salivary immunoglobulin A [IgA]) immune responses in a phase 2 trial of Takeda's bivalent norovirus virus-like particle (VLP) vaccine candidate in 50 ... ...

Abstract	As noroviruses are transmitted through the fecal-oral route, we investigated humoral and mucosal (salivary immunoglobulin A [IgA]) immune responses in a phase 2 trial of Takeda's bivalent norovirus virus-like particle (VLP) vaccine candidate in 50 healthy 18- to 49-year-olds. The vaccine had an acceptable tolerability profile and induced rapid, robust humoral immune responses after 1 intramuscular dose of vaccine candidate. Seroresponses were evident 8 days after vaccination as panimmunoglobulin, IgA, and histo-blood group antigen-blocking antibodies against both vaccine GI.1 and GII.4c genotypes. Salivary IgA levels were approximately 1000-fold lower than serum concentrations, and moderately or strongly correlated with the serum IgA titers at all time-points.
MeSH term(s)	Adolescent ; Adult ; Blood Group Antigens ; Female ; Genotype ; Humans ; Immunity, Humoral ; Immunogenicity, Vaccine ; Immunoglobulin A/blood ; Immunoglobulin A/immunology ; Male ; Middle Aged ; Norovirus/immunology ; Saliva/immunology ; Vaccination ; Vaccines, Virus-Like Particle/immunology ; Viral Vaccines/administration & dosage ; Viral Vaccines/immunology ; Young Adult
Chemical Substances	Blood Group Antigens ; Immunoglobulin A ; Vaccines, Virus-Like Particle ; Viral Vaccines
Language	English
Publishing date	2018-09-06
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiy529
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Article ; Online: Persistence of Antibodies to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: 1-Year Follow-up With Memory Probe Vaccination.

Atmar, Robert L / Baehner, Frank / Cramer, Jakob P / Lloyd, Eric / Sherwood, James / Borkowski, Astrid / Mendelman, Paul M

The Journal of infectious diseases

2019 Volume 220, Issue 4, Page(s) 603–614

Abstract: Background: We previously reported the tolerability and immunogenicity 1 month after intramuscular administration of 2 bivalent virus-like particle (VLP)-based candidate norovirus vaccine formulations in adults. We now describe the persistence of ... ...

Abstract	Background: We previously reported the tolerability and immunogenicity 1 month after intramuscular administration of 2 bivalent virus-like particle (VLP)-based candidate norovirus vaccine formulations in adults. We now describe the persistence of immunity and responses to a memory probe vaccination 1 year later. Methods: A total of 454 healthy men and women aged 18-49 years in 3 equal groups received placebo (saline) or 15/50 or 50/50 vaccine formulations (ie, 15 or 50 µg of GI.1 genotype VLPs, respectively, and 50 µg of GII.4c VLPs) with MPL and Al(OH)3. Immunogenicity and safety were assessed up to day 365, when 351 participants received a memory probe vaccination of 15 µg each of GI.1 and GII.4c VLPs with Al(OH)3. Results: No safety signals were detected up to 1 year after the first vaccination. Pan-immunoglobulin, immunoglobulin A, and histo-blood group antigen-blocking (HBGA) antibody levels among vaccinees waned but remained higher than levels before vaccination and levels in placebo recipients on days 180 and 365. Memory probe vaccination increased all antibody titers. Levels of HBGA antibodies to GI.1 but not GII.4c were higher after the first vaccination in candidate vaccine groups, compared with those in the placebo group. Conclusion: Levels of antibodies to both candidate norovirus VLP formulations persisted above baseline levels for at least 1 year after primary vaccination. HBGA-blocking responses to the memory probe for GI.1 but not GII.4c displayed characteristics of immune memory. Clinical trials registration: NCT02142504.
MeSH term(s)	Adolescent ; Adult ; Blood Group Antigens ; Caliciviridae Infections/blood ; Caliciviridae Infections/prevention & control ; Caliciviridae Infections/virology ; Double-Blind Method ; Female ; Humans ; Immunization, Secondary ; Immunogenicity, Vaccine ; Male ; Middle Aged ; Norovirus/immunology ; United States ; Vaccination ; Vaccines, Virus-Like Particle/immunology ; Viral Vaccines/immunology ; Young Adult
Chemical Substances	Blood Group Antigens ; Vaccines, Virus-Like Particle ; Viral Vaccines
Language	English
Publishing date	2019-04-15
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; 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/jiz170
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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

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