LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 6 of total 6

Search options

  1. Article: Anticipating policy considerations for a future HIV vaccine: a preliminary study

    Williams, Emmanuel Ato / David J.M. Lewis / Maurizio Zazzi / Sylvie Bertholet

    Vaccine. 2016 July 12, v. 34, no. 32

    2016  

    Abstract: New human immunodeficiency virus (HIV) infections continue to occur worldwide. Despite previous failures, there is renewed optimism about developing an efficacious HIV prophylactic vaccine following the 31.2% vaccine efficacy (modified intention to treat ...

    Abstract New human immunodeficiency virus (HIV) infections continue to occur worldwide. Despite previous failures, there is renewed optimism about developing an efficacious HIV prophylactic vaccine following the 31.2% vaccine efficacy (modified intention to treat analysis) achieved in the RV-144 trial. Intense efforts at characterising the immune responses in the trial participants who appeared to gain some protection from the candidate vaccine are ongoing to delineate correlates of protection. However, the characteristics of a vaccine suitable for programmatic introduction in high prevalence areas remain undefined.We set out to ascertain the vaccination policies and strategies that policy makers involved in vaccine introductions would advise were a candidate HIV vaccine to become available.Structured questionnaires in both English and French were self-administered to consenting policy makers such as members of National Immunisation Technical Advisory Groups. Members from three out of the six WHO regional groups were purposively reached for their responses.Thirty-seven key opinion leaders were approached through self-administered questionnaires delivered by e-mail or in person. Nine responses were received, representing a 24.3% response rate. The responses received were from three [Africa (6), Americas (1) and Europe (2)] out of the six WHO regions. All respondents would prioritise the vaccination of commercial sex workers over other risk groups if there was an efficacious HIV vaccine. Vaccine efficacy was considered to be the most important factor, ahead of vaccine safety and cost, in determining the acceptability of a new prophylactic HIV vaccine.It is expected that the first generation HIV vaccines may be modestly efficacious. However, even a modestly efficacious vaccine might curtail the spread of HIV if universal or near-universal coverage is achieved. It is important to anticipate policy discussions which would influence how rapidly an HIV vaccine would be rolled-out programmatically to achieve maximum impact.
    Keywords e-mail ; HIV infections ; Human immunodeficiency virus ; immune response ; issues and policy ; questionnaires ; risk groups ; vaccination ; vaccine development ; vaccines ; Africa ; Europe ; North America ; South America
    Language English
    Dates of publication 2016-0712
    Size p. 3697-3701.
    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.2016.03.086
    Database NAL-Catalogue (AGRICOLA)

    More links

    Kategorien

  2. Article ; Online: Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection.

    Henrik Aggerbeck / Rafaela Giemza / Paulatsya Joshi / Pernille N Tingskov / Søren T Hoff / Julia Boyle / Peter Andersen / David J M Lewis

    PLoS ONE, Vol 8, Iss 5, p e

    2013  Volume 64215

    Abstract: BACKGROUND: Tuberculin skin testing is simple and relatively inexpensive, but the specificity of PPD is affected by BCG vaccination. OBJECTIVE: Determine optimal dose and specificity of recombinant ESAT-6 and CFP-10 (C-Tb) produced in Lactococcus lactis ... ...

    Abstract BACKGROUND: Tuberculin skin testing is simple and relatively inexpensive, but the specificity of PPD is affected by BCG vaccination. OBJECTIVE: Determine optimal dose and specificity of recombinant ESAT-6 and CFP-10 (C-Tb) produced in Lactococcus lactis for diagnosis of M. tuberculosis infection. METHODS: In a dose finding phase I trial 0.01 or 0.1 µg preserved and unpreserved C-Tb was injected by Mantoux technique in 38 patients with active tuberculosis and induration responses measured. In a phase II specificity trial in 151 uninfected, BCG vaccinated participants 0.1 µg C-Tb was compared to 2 TU PPD. RESULTS: 0.1 µg C-Tb gave a median induration of 15 mm after 2 days. Phenol preservation did not affect the response. The specificity of C-Tb was 99.3% (95% CI 96-100%) regarding indurations ≥5 mm as a positive outcome. This was higher than the specificity of PPD (63% using a cut-off of 5 mm or 92% using a cut-off of 15 mm to adjust for non-specific BCG responses). Local adverse reactions following C-Tb injection included transient itching and discomfort as expected components of the immune response. CONCLUSION: C-Tb offers a simple and convenient skin test to diagnose M. tuberculosis infection using a single, universal cut-off unaffected by BCG vaccination. TRIAL REGISTRATION: ClinicalTrials.gov NCT01033929 and NCT01241188.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2013-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    More links

    Kategorien

  3. Article ; Online: Characterization of potential biomarkers of reactogenicity of licensed antiviral vaccines

    January Weiner / David J. M. Lewis / Jeroen Maertzdorf / Hans-Joachim Mollenkopf / Caroline Bodinham / Kat Pizzoferro / Catherine Linley / Aldona Greenwood / Alberto Mantovani / Barbara Bottazzi / Philippe Denoel / Geert Leroux-Roels / Kent E. Kester / Ingileif Jonsdottir / Robert van den Berg / Stefan H. E. Kaufmann / Giuseppe Del Giudice

    Scientific Reports, Vol 9, Iss 1, Pp 1-

    randomized controlled clinical trials conducted by the BIOVACSAFE consortium

    2019  Volume 14

    Abstract: Abstract Biomarkers predictive of inflammatory events post-vaccination could accelerate vaccine development. Within the BIOVACSAFE framework, we conducted three identically designed, placebo-controlled inpatient/outpatient clinical studies (NCT01765413/ ... ...

    Abstract Abstract Biomarkers predictive of inflammatory events post-vaccination could accelerate vaccine development. Within the BIOVACSAFE framework, we conducted three identically designed, placebo-controlled inpatient/outpatient clinical studies (NCT01765413/NCT01771354/NCT01771367). Six antiviral vaccination strategies were evaluated to generate training data-sets of pre-/post-vaccination vital signs, blood changes and whole-blood gene transcripts, and to identify putative biomarkers of early inflammation/reactogenicity that could guide the design of subsequent focused confirmatory studies. Healthy adults (N = 123; 20–21/group) received one immunization at Day (D)0. Alum-adjuvanted hepatitis B vaccine elicited vital signs and inflammatory (CRP/innate cells) responses that were similar between primed/naive vaccinees, and low-level gene responses. MF59-adjuvanted trivalent influenza vaccine (ATIV) induced distinct physiological (temperature/heart rate/reactogenicity) response-patterns not seen with non-adjuvanted TIV or with the other vaccines. ATIV also elicited robust early (D1) activation of IFN-related genes (associated with serum IP-10 levels) and innate-cell-related genes, and changes in monocyte/neutrophil/lymphocyte counts, while TIV elicited similar but lower responses. Due to viral replication kinetics, innate gene activation by live yellow-fever or varicella-zoster virus (YFV/VZV) vaccines was more suspended, with early IFN-associated responses in naïve YFV-vaccine recipients but not in primed VZV-vaccine recipients. Inflammatory responses (physiological/serum markers, innate-signaling transcripts) are therefore a function of the vaccine type/composition and presence/absence of immune memory. The data reported here have guided the design of confirmatory Phase IV trials using ATIV to provide tools to identify inflammatory or reactogenicity biomarkers.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2019-12-01T00:00:00Z
    Publisher Nature Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    More links

    Kategorien

  4. Article ; Online: Systemic and mucosal immune responses to sublingual or intramuscular human papilloma virus antigens in healthy female volunteers.

    Zhiming Huo / Sara L Bissett / Raphaela Giemza / Simon Beddows / Clarissa Oeser / David J M Lewis

    PLoS ONE, Vol 7, Iss 3, p e

    2012  Volume 33736

    Abstract: UNLABELLED:The sublingual route has been proposed as a needle-free option to induce systemic and mucosal immune protection against viral infections. In a translational study of systemic and mucosal humoral immune responses to sublingual or systemically ... ...

    Abstract UNLABELLED:The sublingual route has been proposed as a needle-free option to induce systemic and mucosal immune protection against viral infections. In a translational study of systemic and mucosal humoral immune responses to sublingual or systemically administered viral antigens, eighteen healthy female volunteers aged 19-31 years received three immunizations with a quadravalent Human Papilloma Virus vaccine at 0, 4 and 16 weeks as sublingual drops (SL, n = 12) or intramuscular injection (IM, n = 6). IM antigen delivery induced or boosted HPV-specific serum IgG and pseudovirus-neutralizing antibodies, HPV-specific cervical and vaginal IgG, and elicited circulating IgG and IgA antibody secreting cells. SL antigens induced ~38-fold lower serum and ~2-fold lower cervical/vaginal IgG than IM delivery, and induced or boosted serum virus neutralizing antibody in only 3/12 subjects. Neither route reproducibly induced HPV-specific mucosal IgA. Alternative delivery systems and adjuvants will be required to enhance and evaluate immune responses following sublingual immunization in humans. TRIAL REGISTRATION:ClinicalTrials.govNCT00949572.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2012-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    More links

    Kategorien

  5. Article ; Online: Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally

    Odile Launay / David J.M. Lewis / Alessandra Anemona / Pierre Loulergue / Jo Leahy / Antonella Silvia Sciré / Anaïs Maugard / Elisa Marchetti / Stefano Zancan / Zhiming Huo / Simona Rondini / Rachid Marhaba / Oretta Finco / Laura B. Martin / Jochen Auerbach / Daniel Cohen / Allan Saul / Christiane Gerke / Audino Podda

    EBioMedicine, Vol 22, Iss C, Pp 164-

    Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe

    2017  Volume 172

    Abstract: Background: Approximately 164,000 deaths yearly are due to shigellosis, primarily in developing countries. Thus, a safe and affordable Shigella vaccine is an important public health priority. The GSK Vaccines Institute for Global Health (GVGH) developed ... ...

    Abstract Background: Approximately 164,000 deaths yearly are due to shigellosis, primarily in developing countries. Thus, a safe and affordable Shigella vaccine is an important public health priority. The GSK Vaccines Institute for Global Health (GVGH) developed a candidate Shigella sonnei vaccine (1790GAHB) using the Generalized Modules for Membrane Antigens (GMMA) technology. The paper reports results of 1790GAHB Phase 1 studies in healthy European adults. Methods: To evaluate the safety and immunogenicity profiles of 1790GAHB, we performed two parallel, phase 1, observer-blind, randomized, placebo-controlled, dose escalation studies in France (“study 1”) and the United Kingdom (“study 2”) between February 2014 and April 2015 (ClinicalTrials.gov, number NCT02017899 and NCT02034500, respectively) in 18–45 years old subjects (50 in study 1, 52 in study 2). Increasing doses of Alhydrogel adsorbed 1790, expressed by both O Antigen (OAg) and protein quantity, or placebo were given either by intramuscular route (0.059/1, 0.29/5, 1.5/25, 2.9/50, 5.9/100 μg of OAg/μg of protein; study 1) or by intradermal (ID), intranasal (IN) or intramuscular (IM) route of immunization (0.0059/0.1, 0.059/1, 0.59/10 μg ID, 0.29/5, 1.2/20, 4.8/80 μg IN and 0.29/5 μg IM, respectively; study 2). In absence of serologic correlates of protection for Shigella sonnei, vaccine induced immunogenicity was compared to anti-LPS antibody in a population naturally exposed to S. sonnei. Findings: Vaccines were well tolerated in both studies and no death or vaccine related serious adverse events were reported. In study 1, doses ≥1.5/25 μg elicited serum IgG median antibody greater than median level in convalescent subjects after the first dose. No vaccine group in study 2 achieved median antibody greater than the median convalescent antibody. Interpretation: Intramuscularly administered Shigella sonnei GMMA vaccine is well tolerated, up to and including 5.9/100 μg and induces antibody to the OAg of at least the same magnitude of those observed following ...
    Keywords Shigella sonnei ; Vaccine ; Clinical study ; GMMA ; Medicine ; R ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2017-08-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    More links

    Kategorien

  6. Article ; Online: Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

    David J M Lewis / Zhiming Huo / Susan Barnett / Ingrid Kromann / Rafaela Giemza / Eva Galiza / Maria Woodrow / Birgit Thierry-Carstensen / Peter Andersen / Deborah Novicki / Giuseppe Del Giudice / Rino Rappuoli

    PLoS ONE, Vol 4, Iss 9, p e

    2009  Volume 6999

    Abstract: An association was previously established between facial nerve paralysis (Bell's palsy) and intranasal administration of an inactivated influenza virosome vaccine containing an enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant. The ... ...

    Abstract An association was previously established between facial nerve paralysis (Bell's palsy) and intranasal administration of an inactivated influenza virosome vaccine containing an enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant. The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn.Subjects participating in two contemporaneous non-randomized Phase 1 clinical trials of nasal subunit vaccines against Human Immunodeficiency Virus and tuberculosis, both of which employed an enzymatically inactive non-toxic mutant LT adjuvant (LTK63), underwent active follow-up for adverse events using diary-cards and clinical examination. Two healthy subjects experienced transient peripheral facial nerve palsies 44 and 60 days after passive nasal instillation of LTK63, possibly a result of retrograde axonal transport after neuronal ganglioside binding or an inflammatory immune response, but without exaggerated immune responses to LTK63.While the unique anatomical predisposition of the facial nerve to compression suggests nasal delivery of neuronal-binding LT-derived adjuvants is inadvisable, their continued investigation as topical or mucosal adjuvants and antigens appears warranted on the basis of longstanding safety via oral, percutaneous, and other mucosal routes.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2009-09-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    More links

    Kategorien

To top