The Experts below are selected from a list of 23034 Experts worldwide ranked by ideXlab platform
Pierre Van Damme - One of the best experts on this subject based on the ideXlab platform.
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evaluation of non inferiority of Intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques a randomised comparative study
2010Co-Authors: Pierre Van Damme, Robert Arnou, Froukje Kafeja, Anne Fiquet, Patrick Richard, Stephane Thomas, Gilles Meghlaoui, Sandrine I Samson, Emilio LedesmaAbstract:Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an Intradermal vaccination route. The immunogenicity of an Intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly. Elderly volunteers (age ≥ 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 μg haemagglutinin [HA]/strain/0.1-ml dose administered Intradermally, or a subunit vaccine (15 μg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 ± 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the Intradermal vaccine was non-inferior to the adjuvanted vaccine. A total of 795 participants were enrolled (Intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the Intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the Intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the Intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration. The immunogenicity and safety of the Intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of the skin appears to be an appropriate strategy to address the challenge of declining immune responses in the elderly. ClinicalTrials.gov: NCT00554333.
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Intradermal influenza vaccine for older adults a randomized controlled multicenter phase iii study
2009Co-Authors: Robert Arnou, Arvydas Ambrozaitis, Mariepierre Kazek, Giancarlo Icardi, Marijke De Decker, Frana Oise Weber, Pierre Van DammeAbstract:In a 3-year, randomized, controlled, open-label phase III trial enrolling 3707 adults aged > or = 60 years we evaluated whether the immunogenicity of an Intradermal trivalent inactivated seasonal influenza vaccine, containing 15 microg of haemagglutinin per strain per 0.1 ml dose, is superior to that of a conventional intramuscular vaccine. Intradermal vaccine was given using an Intradermal microinjection system. After the first vaccination, both vaccines satisfied the immunogenicity criteria for influenza vaccines for older adults set out in European regulatory guidelines, and geometric mean haemagglutination inhibition antibody titers and seroprotection rates were higher (statistically superior) with Intradermal vaccination. Higher immune responses with Intradermal vaccine were also observed after the 2nd and 3rd annual vaccinations. Both vaccines were well tolerated with similar systemic reactogenicity profiles. This Intradermal influenza vaccine for older adults is a beneficial option for influenza protection, consistently enhancing antibody responses without compromising safety.
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Safety and efficacy of a novel microneedle device for dose sparing Intradermal influenza vaccination in healthy adults
2009Co-Authors: Pierre Van Damme, Marie Van Der Wielen, Froukje Oosterhuis-kafeja, Yotam Almagor, Ofer Sharon, Yotam LevinAbstract:Background: Intradermal vaccine delivery has been shown to induce good immune responses with low vaccine doses. Technologies for drug-delivery which specifically target the skin may render Intradermal vaccination more accessible. Methods: We conducted a prospective, randomized trial in 180 intended-to-treat healthy adults. Study objectives were to evaluate the safety and immunogenicity of low-dose Intradermal (ID) influenza vaccines delivered using a novel microneedle device (MicronJet). This device replaces a conventional needle, and is designed specifically for Intradermal delivery. Subjects were randomly assigned to receive either the full-dose standard flu shot (containing 15 μg hemagglutinin per strain) delivered intramuscularly using a conventional needle (IM group), a medium dose Intradermal injection (6 μg hemagglutinin per strain) delivered with the MicronJet (ID2 group), or a low-dose Intradermal injection (3 μg hemagglutinin per strain) delivered with the MicronJet (ID1 group). A marketed influenza vaccine for the 2006/2007 influenza season (α-RIX® by GSK Biologicals) was used for all injections. Adverse events were recorded over a 42-day period. Immunogenicity was evaluated by changes in hemagglutination inhibition (HAI) antibody titer, and by comparing geometric mean titers (GMTs), seroconversion, and seroprotection rates between the study groups. Results: Local reactions were significantly more frequent following Intradermal vaccination, but were mild and transient in nature. At 21 days after injection, GMT fold increase was 22, 18 and 22 in the ID1, ID2 and IM groups respectively for the H1N1 strain; 9, 9 and 16 for the H3N2 strain and 9, 13 and 11 for strain B. The CPMP criteria for re-licensure of seasonal influenza vaccines were met in full for all study groups. Conclusions: Low-dose influenza vaccines delivered Intradermally using microneedles elicited immunogenic responses similar to those elicited by the full-dose intramuscular vaccination. The microneedle injection device used in this study was found to be effective, safe, and reliable. © 2008.
Fernanda H Sakamoto - One of the best experts on this subject based on the ideXlab platform.
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intracutaneous ala photodynamic therapy dose dependent targeting of skin structures
2011Co-Authors: Fernanda H Sakamoto, Apostolos G Doukas, William A Farinelli, Zeina Tannous, Nicholas A Smith, David Zurakowski, Rox R AndersonAbstract:Background Photodynamic therapy (PDT) using topical aminolevulinic acid (ALA) depends on local drug uptake, metabolism to porphyrins, and depth of light penetration using different wavelengths. Topical ALA-PDT has limited depth of drug penetration. We studied induced porphyrin distribution and PDT after Intradermal ALA administration using different drug concentrations followed by high-fluence red light irradiation. Materials and Methods Intradermal injections (∼2 mm deep) of ALA concentrations from 0.0005% to 1% were studied in swine to evaluated porphyrin fluorescence before PDT and clinical and histological damage 24 hours after PDT. Porphyrin accumulation was measured by fluorescence microscopy of frozen section. PDT was performed 3 hours after Intradermal injections using a 635 nm LED array at a fluence of 200 J/cm2. Skin responses to PDT were observed grossly and by histology (blind evaluation). Results Intradermal ALA caused porphyrin accumulation in epidermis, hair follicles (HF), sebaceous glands (SG), sweat glands (eccrine glands, EG and apocrine glands, AG), and subcutaneous fat. Significant differences of fluorescence intensity were observed between different skin structures (P 0.05). Intradermal ALA is potent. ALA concentrations ≥0.25% followed by red light exposures caused a very intense vascular PDT reaction. Moderate doses of injected ALA concentration (∼0.06%), selectively targeted EG. Low doses (≤0.016%) targeted fat; producing fat necrosis with minimal inflammation, manifested both clinically and histologically. In contrast to topical ALA-PDT, Intradermal ALA-PDT can effectively photosensitize deep skin structures. Conclusion Potentially, Intradermal ALA-PDT using various ALA concentrations may be useful for treating vascular lesions (malformations, hemangiomas, tumors), EG/AG disorders, fat or deep targets in skin. Lasers Surg. Med. 43:621–631, 2011. © 2011 Wiley-Liss, Inc.
Francoise Weber - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity large scale safety and lot consistency of an Intradermal influenza vaccine in adults aged 18 60 years randomized controlled phase iii trial
2010Co-Authors: Robert Arnou, Patrick Eavis, Joseramon De Juanes Pardo, Arvydas Ambrozaitis, Mariepierre Kazek, Francoise WeberAbstract:Background: Vaccination is the most effective way of reducing the large health and economic burden of influenza, yet vaccination coverage remains low, particularly among non-elderly adults. Intradermal influenza vaccine produce an effective immune response and represents an alternative to intramuscular influenza vaccination. Methods: A Phase III multicentre, randomised, controlled, double-blind (for the three different lots of Intradermal vaccine) study assessed lot-to-lot consistency, immunogenicity and safety of an Intradermal inactivated trivalent split-virion influenza vaccine in 2255 adults aged 18–60 years. Participants received one of three lots of Intradermal vaccine containing 9 µg of haemagglutinin per influenza strain, or a licensed intramuscular control vaccine containing 15 µg haemagglutinin/strain. Results: The three industrial lots of Intradermal vaccine were equivalent in terms of post-vaccination titres elicited by day 21. The Intradermal and intramuscular vaccines induced similar post-va...
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Intradermal influenza vaccination of healthy adults using a new microinjection system a 3 year randomised controlled safety and immunogenicity trial
2009Co-Authors: Jiri Beran, Arvydas Ambrozaitis, Alvydas Pranas Laiskonis, Narseta Mickuviene, Patrick Bacart, Yvan Calozet, Etienne Demanet, Stephane Heijmans, Paul Van Belle, Francoise WeberAbstract:Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given Intradermally using a microinjection system compared with an intramuscular control vaccine. In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrolment) received three annual vaccinations of Intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3 μg or 6 μg haemagglutinin/strain/dose of inactivated influenza vaccine Intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15 μg/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9 μg/strain/dose Intradermally or 15 μg intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9 μg Intradermally or 15 μg intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study. In Years 2 and 3, 9 μg Intradermal was comparably immunogenic to 15 μg intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3 μg and 6 μg Intradermal formulations were less immunogenic than intramuscular 15 μg. Safety of the Intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the Intradermal route. An influenza vaccine with 9 μg of haemagglutinin/strain given using an Intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years. Clinicaltrials.gov NCT00703651.
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seasonal influenza vaccine delivered by Intradermal microinjection a randomised controlled safety and immunogenicity trial in adults
2008Co-Authors: Isabel Lerouxroels, Francoise Weber, Eva Vets, Ralf Freese, Michael Seiberling, Camille Salamand, Geert LerouxroelsAbstract:Influenza vaccines remain largely underused. A promising alternative to Current intramuscular vaccines is a trivalent inactivated influenza vaccine (TIV) delivered using a microinjection system to offer a less invasive and possibly more acceptable vaccination. A phase 11, multicentre, randomised open-label study in 978 healthy adults (18-57 years) evaluated the immunogenicity and safety of Intradermal TIV. Subjects received a 0.1 ml injection of Intradermal TIV, containing 9 mu g of haemagglutinin (HA) per strain (it = 588) or a conventional 0.5 ml intramuscular vaccine (15 mu g of HA/strain: n = 390). Intradermal,11 TIV induced non-inferior humoral immune responses against all three strains and superior responses against both A strains (H1N1, H3N2) compared with the control. Both vaccines were well tolerated. (C) 2008 Elsevier Ltd. All rights reserved.
Gregory M. Glenn - One of the best experts on this subject based on the ideXlab platform.
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dose sparing with Intradermal injection of influenza vaccine
2004Co-Authors: Richard T Kenney, Sarah A Frech, Larry R Muenz, Christina P Villar, Gregory M. GlennAbstract:BACKGROUND: The loss of half the U.S. supply of influenza vaccine due to contamination has created a critical shortage. Dose-sparing strategies that use Intradermal delivery of vaccines may be one approach to consider. METHODS: We conducted a randomized, open-label trial outside the influenza season in 100 healthy adults 18 to 40 years of age to compare the immunogenicity and safety of Intradermal immunization with influenza vaccine with standard intramuscular immunization. Subjects were randomly assigned to receive either a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microg of hemagglutinin per strain, by means of a prefilled syringe or a single Intradermal dose of 0.1 ml, containing at least 3 microg of hemagglutinin per strain, by means of a fine-gauge needle; both injections were in the deltoid region. Changes in the hemagglutination-inhibition (HAI) antibody titer were assessed by comparing geometric mean titers and fold increases relative to baseline values and by comparing changes in the seroconversion and seroprotection rates. Local and systemic adverse events were assessed after both types of vaccination. RESULTS: Subjects who received an Intradermal injection with one fifth the standard dose of influenza vaccine had increases in the geometric mean HAI titer by a factor of 15.2 for the H1N1 strain in the vaccine, 19.0 for the H3N2 strain, and 12.4 for the B strain on day 21, as compared with respective increases by a factor of 14.9, 7.1, and 15.3 for the intramuscular injection of the standard dose. Seroconversion and seroprotection rates were similar in the two groups on day 21, ranging from 66 to 82 percent and 84 to 100 percent, respectively. Local reactions were significantly more frequent among recipients of Intradermal injections than among recipients of intramuscular injections, but such reactions were mild and transient. CONCLUSIONS: In this study of young adults, Intradermal administration of one fifth the standard intramuscular dose of an influenza vaccine elicited immunogenicity that was similar to or better than that elicited by intramuscular injection. Intradermal administration could be used to expand the supplies of influenza vaccine, but further studies are needed before this strategy can be recommended for routine use.
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dose sparing with Intradermal injection of influenza vaccine
2004Co-Authors: Richard T Kenney, Sarah A Frech, Larry R Muenz, Christina P Villar, Gregory M. GlennAbstract:Background The loss of half the U.S. supply of influenza vaccine due to contamination has created a critical shortage. Dose-sparing strategies that use Intradermal delivery of vaccines may be one approach to consider. Methods We conducted a randomized, open-label trial outside the influenza season in 100 healthy adults 18 to 40 years of age to compare the immunogenicity and safety of Intradermal immunization with influenza vaccine with standard intramuscular immunization. Subjects were randomly assigned to receive either a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 μg of hemagglutinin per strain, by means of a prefilled syringe or a single Intradermal dose of 0.1 ml, containing at least 3 μg of hemagglutinin per strain, by means of a fine-gauge needle; both injections were in the deltoid region. Changes in the hemagglutination-inhibition (HAI) antibody titer were assessed by comparing geometric mean titers and fold increases relative to baseline values and b...
Rox R Anderson - One of the best experts on this subject based on the ideXlab platform.
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intracutaneous ala photodynamic therapy dose dependent targeting of skin structures
2011Co-Authors: Fernanda H Sakamoto, Apostolos G Doukas, William A Farinelli, Zeina Tannous, Nicholas A Smith, David Zurakowski, Rox R AndersonAbstract:Background Photodynamic therapy (PDT) using topical aminolevulinic acid (ALA) depends on local drug uptake, metabolism to porphyrins, and depth of light penetration using different wavelengths. Topical ALA-PDT has limited depth of drug penetration. We studied induced porphyrin distribution and PDT after Intradermal ALA administration using different drug concentrations followed by high-fluence red light irradiation. Materials and Methods Intradermal injections (∼2 mm deep) of ALA concentrations from 0.0005% to 1% were studied in swine to evaluated porphyrin fluorescence before PDT and clinical and histological damage 24 hours after PDT. Porphyrin accumulation was measured by fluorescence microscopy of frozen section. PDT was performed 3 hours after Intradermal injections using a 635 nm LED array at a fluence of 200 J/cm2. Skin responses to PDT were observed grossly and by histology (blind evaluation). Results Intradermal ALA caused porphyrin accumulation in epidermis, hair follicles (HF), sebaceous glands (SG), sweat glands (eccrine glands, EG and apocrine glands, AG), and subcutaneous fat. Significant differences of fluorescence intensity were observed between different skin structures (P 0.05). Intradermal ALA is potent. ALA concentrations ≥0.25% followed by red light exposures caused a very intense vascular PDT reaction. Moderate doses of injected ALA concentration (∼0.06%), selectively targeted EG. Low doses (≤0.016%) targeted fat; producing fat necrosis with minimal inflammation, manifested both clinically and histologically. In contrast to topical ALA-PDT, Intradermal ALA-PDT can effectively photosensitize deep skin structures. Conclusion Potentially, Intradermal ALA-PDT using various ALA concentrations may be useful for treating vascular lesions (malformations, hemangiomas, tumors), EG/AG disorders, fat or deep targets in skin. Lasers Surg. Med. 43:621–631, 2011. © 2011 Wiley-Liss, Inc.