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  1. Article ; Online: Could less be more? Accounting for fractional-dose regimens and different number of vaccine doses when measuring the impact of the RTS, S/AS01E malaria vaccine.

    Westercamp, Nelli / Osei-Tutu, Lawrence / Schuerman, Lode / Kariuki, Simon K / Bollaerts, Anne / Lee, Cynthia K / Samuels, Aaron M / Ockenhouse, Christian / Bii, Dennis K / Adjei, Samuel / Oneko, Martina / Lievens, Marc / Attobrah Sarfo, Maame Anima / Atieno, Cecilia / Bakari, Ashura / Sang, Tony / Kotoh-Mortty, Maame Fremah / Otieno, Kephas / Roman, François /
    Buabeng, Patrick Boakye Yiadom / Ntiamoah, Yaw / Ansong, Daniel / Agbenyega, Tsiri / Ofori-Anyinam, Opokua

    The Journal of infectious diseases

    2024  

    Abstract: Background: The RTS, S/AS01E malaria vaccine (RTS, S) is recommended for children in moderate-to-high Plasmodium falciparum malaria transmission areas. This phase 2b trial (NCT03276962) evaluates RTS, S fractional- and full-dose regimens in Ghana and ... ...

    Abstract Background: The RTS, S/AS01E malaria vaccine (RTS, S) is recommended for children in moderate-to-high Plasmodium falciparum malaria transmission areas. This phase 2b trial (NCT03276962) evaluates RTS, S fractional- and full-dose regimens in Ghana and Kenya.
    Methods: 1500 children aged 5-17 months were randomised (1:1:1:1:1) to receive RTS, S or rabies control vaccine. RTS, S groups received two full RTS, S doses at month (M)0/M1 followed by either full (groups R012-20, R012-14-26) or fractional (1/5) doses (groups Fx012-14-26, Fx017-20-32).
    Results: At M32 post-first dose, vaccine efficacy (VE) against clinical malaria (all episodes) ranged from 38% (R012-20; 95%CI: 24-49) to 53% (R012-14-26; 95%CI: 42-62). Vaccine impact estimates (cumulative number of malaria cases averted/1000 children vaccinated) were 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional- versus full-dose), in a post-hoc analysis, we also estimated cases averted/1000 RTS, S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), 880 (Fx017-20-32).
    Conclusions: VE against clinical malaria was similar in all RTS, S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. If borne out through trial end (M50), these observations underscore the means to reduce cost per regimen with a goal of maximising impact and optimising supply.
    Language English
    Publishing date 2024-03-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiae075
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Genotypic analysis of RTS,S/AS01

    Juraska, Michal / Early, Angela M / Li, Li / Schaffner, Stephen F / Lievens, Marc / Khorgade, Akanksha / Simpkins, Brian / Hejazi, Nima S / Benkeser, David / Wang, Qi / Mercer, Laina D / Adjei, Samuel / Agbenyega, Tsiri / Anderson, Scott / Ansong, Daniel / Bii, Dennis K / Buabeng, Patrick B Y / English, Sean / Fitzgerald, Nicholas /
    Grimsby, Jonna / Kariuki, Simon K / Otieno, Kephas / Roman, François / Samuels, Aaron M / Westercamp, Nelli / Ockenhouse, Christian F / Ofori-Anyinam, Opokua / Lee, Cynthia K / MacInnis, Bronwyn L / Wirth, Dyann F / Gilbert, Peter B / Neafsey, Daniel E

    The Lancet. Infectious diseases

    2024  

    Abstract: Background: The first licensed malaria vaccine, RTS,S/AS01: Methods: Between Sept 28, 2017, and Sept 25, 2018, 1500 children aged 5-17 months were randomly assigned (1:1:1:1:1) to receive four different RTS,S/AS01: Findings: We observed ... ...

    Abstract Background: The first licensed malaria vaccine, RTS,S/AS01
    Methods: Between Sept 28, 2017, and Sept 25, 2018, 1500 children aged 5-17 months were randomly assigned (1:1:1:1:1) to receive four different RTS,S/AS01
    Findings: We observed significant and similar vaccine efficacy (25-43%; 95% CI union 9-53) against first new infection for all four RTS,S/AS01
    Interpretation: All tested dosing regimens blocked some infections to a similar degree. Improved vaccine efficacy in participants infected during vaccination could suggest new strategies for highly efficacious malaria vaccine development and implementation.
    Funding: GlaxoSmithKline Biologicals SA, PATH, Bill & Melinda Gates Foundation, and the German Federal Ministry of Education and Research.
    Language English
    Publishing date 2024-05-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(24)00179-8
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  3. Article: Baseline malaria infection status and RTS,S/AS01E malaria vaccine efficacy.

    Juraska, Michal / Early, Angela M / Li, Li / Schaffner, Stephen F / Lievens, Marc / Khorgade, Akanksha / Simpkins, Brian / Hejazi, Nima S / Benkeser, David A / Wang, Qi / Mercer, Laina D / Adjei, Samuel / Agbenyega, Tsiri / Anderson, Scott / Ansong, Daniel / Bii, Dennis K / Buabeng, Patrick B Y / English, Sean / Fitzgerald, Nicholas /
    Grimsby, Jonna / Kariuki, Simon K / Otieno, Kephas / Roman, François / Samuels, Aaron M / Westercamp, Nelli / Ockenhouse, Christian F / Ofori-Anyinam, Opokua / Lee, Cynthia K / MacInnis, Bronwyn L / Wirth, Dyann F / Gilbert, Peter B / Neafsey, Daniel E

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: The only licensed malaria vaccine, RTS,S/AS01 : Methods: 1,500 children aged 5-17 months were randomized to receive four different RTS,S/AS01 : Results: We observed significant and comparable VE (25-43%, 95% CI union 9-53%) against ... ...

    Abstract Background: The only licensed malaria vaccine, RTS,S/AS01
    Methods: 1,500 children aged 5-17 months were randomized to receive four different RTS,S/AS01
    Results: We observed significant and comparable VE (25-43%, 95% CI union 9-53%) against first new infection for all four RTS,S/AS01
    Conclusions: All tested dosing regimens blocked some infections to a similar degree. Improved VE in participants infected during vaccination could suggest new strategies for highly efficacious malaria vaccine development and implementation. ( ClinicalTrials.gov number, NCT03276962 ).
    Language English
    Publishing date 2023-11-23
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.11.22.23298907
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Efficacy of RTS,S/AS01

    Samuels, Aaron M / Ansong, Daniel / Kariuki, Simon K / Adjei, Samuel / Bollaerts, Anne / Ockenhouse, Christian / Westercamp, Nelli / Lee, Cynthia K / Schuerman, Lode / Bii, Dennis K / Osei-Tutu, Lawrence / Oneko, Martina / Lievens, Marc / Attobrah Sarfo, Maame Anima / Atieno, Cecilia / Morelle, Danielle / Bakari, Ashura / Sang, Tony / Jongert, Erik /
    Kotoh-Mortty, Maame Fremah / Otieno, Kephas / Roman, François / Buabeng, Patrick Boakye Yiadom / Ntiamoah, Yaw / Ofori-Anyinam, Opokua / Agbenyega, Tsiri

    The Lancet. Infectious diseases

    2022  Volume 22, Issue 9, Page(s) 1329–1342

    Abstract: Background: Controlled infection studies in malaria-naive adults suggest increased vaccine efficacy for fractional-dose versus full-dose regimens of RTS,S/AS01. We report first results of an ongoing trial assessing different fractional-dose regimens in ... ...

    Abstract Background: Controlled infection studies in malaria-naive adults suggest increased vaccine efficacy for fractional-dose versus full-dose regimens of RTS,S/AS01. We report first results of an ongoing trial assessing different fractional-dose regimens in children, in natural exposure settings.
    Methods: This open-label, phase 2b, randomised controlled trial is conducted at the Malaria Research Center, Agogo, Ashanti Region (Ghana), and the Kenya Medical Research Institute and the US Centers for Disease Control and Prevention site in Siaya County (Kenya). We enrolled children aged 5-17 months without serious acute or chronic illness who had previously received three doses of diphtheria, tetanus, pertussis, and hepatitis B vaccine and at least three doses of oral polio vaccine. Children were randomly assigned (1:1:1:1:1) using a web-based randomisation system with a minimisation procedure accounting for centre to receive rabies control vaccine (M012 schedule) or two full doses of RTS,S/AS01
    Findings: Between Sept 28, 2017, and Sept 25, 2018, 2157 children were enrolled, of whom 1609 were randomly assigned to a treatment group (322 to each RTS,S/AS01
    Interpretation: The Fx012-14 regimen was not superior to the standard regimen over 12 months after dose three. All RTS,S/AS01
    Funding: GlaxoSmithKline Biologicals; PATH's Malaria Vaccine Initiative.
    MeSH term(s) Adult ; Child ; Ghana ; Humans ; Kenya ; Malaria ; Malaria Vaccines ; Malaria, Falciparum ; Rabies Vaccines
    Chemical Substances Malaria Vaccines ; Rabies Vaccines
    Language English
    Publishing date 2022-06-23
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(22)00273-0
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  5. Article ; Online: Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial.

    Oneko, Martina / Steinhardt, Laura C / Yego, Reuben / Wiegand, Ryan E / Swanson, Phillip A / Kc, Natasha / Akach, Dorcas / Sang, Tony / Gutman, Julie R / Nzuu, Elizabeth L / Dungani, Allan / Kim Lee Sim, B / Oloo, Paul Ndaya / Otieno, Kephas / Bii, Dennis K / Billingsley, Peter F / James, Eric R / Kariuki, Simon / Samuels, Aaron M /
    Jongo, Said / Chebore, Winnie / Abdulla, Salim / Daubenberger, Claudia / Mpina, Maxmillian / Styers, David / Potter, Gail E / Abarbanell, Ginnie / Richie, Thomas L / Hoffman, Stephen L / Seder, Robert A

    Nature medicine

    2021  Volume 27, Issue 9, Page(s) 1636–1645

    Abstract: The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily ... ...

    Abstract The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination. However, previous malaria exposure can limit immune responses and vaccine efficacy (VE) in adults. We hypothesized that infants with less previous exposure to malaria would have improved immunity and protection. We conducted a multi-arm, randomized, double-blind, placebo-controlled trial in 336 infants aged 5-12 months to determine the safety, tolerability, immunogenicity and efficacy of the PfSPZ Vaccine in infants in a high-transmission malaria setting in western Kenya ( NCT02687373 ). Groups of 84 infants each received 4.5 × 10
    MeSH term(s) Adult ; Antibody Formation/drug effects ; Antibody Formation/immunology ; B-Lymphocytes/drug effects ; B-Lymphocytes/immunology ; Double-Blind Method ; Humans ; Infant ; Kenya/epidemiology ; Malaria Vaccines/administration & dosage ; Malaria Vaccines/adverse effects ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/immunology ; Malaria, Falciparum/parasitology ; Malaria, Falciparum/prevention & control ; Plasmodium falciparum/drug effects ; Plasmodium falciparum/pathogenicity ; Sporozoites/drug effects ; Sporozoites/pathogenicity ; T-Lymphocytes/drug effects ; Vaccination ; Vaccines, Attenuated/administration & dosage ; Vaccines, Attenuated/adverse effects
    Chemical Substances Malaria Vaccines ; Vaccines, Attenuated
    Language English
    Publishing date 2021-09-13
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-021-01470-y
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  6. Article ; Online: Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Morrison, Susan / John-Stewart, Grace / Egessa, John J / Mubezi, Sezi / Kusemererwa, Sylvia / Bii, Dennis K / Bulya, Nulu / Mugume, Francis / Campbell, James D / Wangisi, Jonathan / Bukusi, Elizabeth A / Celum, Connie / Baeten, Jared M

    PloS one

    2015  Volume 10, Issue 10, Page(s) e0140773

    Abstract: During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite ...

    Abstract During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.
    MeSH term(s) Adult ; Africa, Eastern ; Anti-HIV Agents/administration & dosage ; Breast Feeding/adverse effects ; Early Medical Intervention ; Emtricitabine/administration & dosage ; Female ; HIV Infections/drug therapy ; HIV-1 ; Humans ; Infant, Newborn ; Infectious Disease Transmission, Vertical/prevention & control ; Post-Exposure Prophylaxis/methods ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy ; Tenofovir/administration & dosage ; Young Adult
    Chemical Substances Anti-HIV Agents ; Tenofovir (99YXE507IL) ; Emtricitabine (G70B4ETF4S)
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0140773
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