A5083056084- Malaria Research and Control
- Mosquito-borne diseases and control
- Tuberculosis Research and Epidemiology
- vaccines and immunoinformatics approaches
- HIV Research and Treatment
- Influenza Virus Research Studies
- Immunodeficiency and Autoimmune Disorders
- Pneumonia and Respiratory Infections
- SARS-CoV-2 and COVID-19 Research
- Hepatitis C virus research
- Viral Infections and Outbreaks Research
- Computational Drug Discovery Methods
- Viral Infections and Immunology Research
- Vaccine Coverage and Hesitancy
- Complement system in diseases
- Respiratory viral infections research
- Hepatitis Viruses Studies and Epidemiology
- Hepatitis B Virus Studies
- Immunotherapy and Immune Responses
- Pneumocystis jirovecii pneumonia detection and treatment
- Plant Virus Research Studies
- Pharmacovigilance and Adverse Drug Reactions
- Vibrio bacteria research studies
- Mycobacterium research and diagnosis
- Pharmaceutical Quality and Counterfeiting
GlaxoSmithKline (Belgium)
2016-2025
GlaxoSmithKline (Netherlands)
2022
University of Bamenda
2018
GlaxoSmithKline (India)
2018
Creative Commons
2016
YR Gaitonde Centre for AIDS Research and Education
2016
GlaxoSmithKline (United Kingdom)
2005-2014
GlaxoSmithKline (United States)
2014
National Alliance on Mental Illness
2014
Ghent University Hospital
2010
To further increase the efficacy of malaria vaccine RTS,S/AS02A, we tested RTS,S antigen formulated using AS01B Adjuvant System (GlaxoSmithKline Biologicals).In a double-blind, randomized trial, 102 healthy volunteers were evenly allocated to receive RTS,S/AS01B or RTS,S/AS02A at months 0, 1, and 2 study, followed by challenge. Protected recipients rechallenged 5 later.RTS,S/AS01B well tolerated safe. The was 50% (95% confidence interval [CI], 32.9%-67.1%) 32% CI, 17.6%-47.6%), respectively....
Malaria control remains a challenge in many parts of the Sahel and sub-Sahel regions Africa.We conducted an individually randomized, controlled trial to assess whether seasonal vaccination with RTS,S/AS01E was noninferior chemoprevention preventing uncomplicated malaria two interventions combined were superior either one alone severe malaria-related outcomes.We randomly assigned 6861 children 5 17 months age receive sulfadoxine-pyrimethamine amodiaquine (2287 [chemoprevention-alone group]),...
Background This Phase 1/2a study evaluated the safety, immunogenicity, and efficacy of an experimental malaria vaccine comprised recombinant Plasmodium falciparum protein apical membrane antigen-1 (AMA-1) representing 3D7 allele formulated with either AS01B or AS02A Adjuvant Systems. Methodology/Principal Findings After a preliminary safety evaluation low dose AMA-1/AS01B (10 µg/0.5 mL) in 5 adults, 30 malaria-naïve adults were randomly allocated to receive full (50 (n = 15) AMA-1/AS02A 15),...
This study advances the clinical development of RTS,S/AS01B candidate malaria vaccine to endemic populations. As a primary objective it compares safety and reactogenicity more extensively evaluated RTS,S/AS02A vaccine.A Phase IIb, single centre, double-blind, controlled trial 6 months duration with subsequent month single-blind follow-up conducted in Kisumu West District, Kenya between August 2005 2006. 255 healthy adults aged 18 35 years were randomized (1ratio1ratio1) receive 3 doses...
Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other lineage. We evaluated efficacy a candidate inactivated quadrivalent vaccine (QIV) containing both lineages.In this multinational, phase 3, observer-blinded study, we randomly assigned children 3 to 8 years age, in 1:1 ratio, receive QIV or hepatitis A (control). The primary end point was confirmed by real-time polymerase chain reaction (rt-PCR). Secondary points were...
Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on global TB epidemic. Safety, reactogenicity and immunogenicity of vaccine candidate M72/AS01E was evaluated healthy, HIV-negative adolescents a endemic region, regardless Mycobacterium (M.tb) infection status. In phase II, double-blind randomized, controlled study (NCT00950612), two doses or placebo were administered intramuscularly, one month apart. Participants followed-up...
Tuberculosis (TB) is a major cause of morbidity and mortality worldwide, thus there an urgent need for novel TB vaccines.We investigated vaccine candidate, M72/AS01, in phase IIa trial bacille Calmette-Guérin-vaccinated, HIV-uninfected, Mycobacterium tuberculosis (Mtb)-infected -uninfected adults South Africa.Two doses M72/AS01 were administered to healthy adults, with without latent Mtb infection. Participants monitored 7 months after the first dose; cytokine production profiles, cell...
<h2>Summary</h2><h3>Background</h3> Seasonal vaccination with the RTS,S/AS01<sub>E</sub> vaccine combined seasonal malaria chemoprevention (SMC) prevented in young children more effectively than either intervention given alone over a 3 year period. The objective of this study was to establish whether added protection provided by combination could be sustained for further 2 years. <h3>Methods</h3> This double-blind, individually randomised, controlled, non-inferiority and superiority, phase...
Patterns of expressed genes in the peripheral blood mononuclear cells persons who were receiving RTS,S/AS01 or RTS,S/AS02 malaria vaccine and undergoing experimental challenge with mosquito-borne falciparum examined to identify markers associated protection.Thirty-nine recipients assessed at study entry; on day third vaccination; 24 h, 72 2 weeks after 5 challenge. Of 39 recipients, 13 protected 26 not. Eleven exhibited delayed onset parasitemia. All infectivity control subjects developed...
Tuberculosis (TB) remains uncontrolled in many parts of the world and development an effective vaccine against TB represents a high priority unmet medical need. Healthy PPD (tuberculin purified protein derivative)-negative adult volunteers, aged 18-40 years received three doses candidate Mtb72F/AS02A according to 0-1-2 months schedule open-label Phase I study (NCT00730795). Solicited, unsolicited serious adverse events (AEs), hematological biochemical laboratory parameters were assessed....
A phase 2a RTS,S/AS malaria vaccine trial, conducted previously at the Walter Reed Army Institute of Research, conferred sterile immunity against a primary challenge with infectious sporozoites in 40% 80 subjects enrolled study. The frequency Plasmodium falciparum circumsporozoite protein (CSP)-specific CD4+ T cells was significantly higher protected as compared to non-protected subjects. Intrigued by these unique vaccine-related correlates protection, present study we asked whether RTS,S...
In this dose-finding Phase II study (NCT00621322), we evaluated the safety and immunogenicity of different formulations candidate tuberculosis vaccine containing M72 antigen (10/20/40 μg doses) liposome-based AS01 Adjuvant System. We aimed to select lowest-dose combination that was clinically well tolerated with comparable previously tested M72/AS01B (40 μg) vaccine. Healthy PPD-positive (induration 3–10 mm) adults (18–45 years) in The Philippines were randomized (4:4:4:4:1:1) receive 2...
A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment quality systems was a requirement for trial conduct to meet international regulatory standards, as well providing an important capacity strengthening opportunity centres. Standardized laboratory methods assurance processes were implemented at each centres, facilitated by funding partners. robust protocol determination parasite density...
Previous studies have shown that the M72/AS01E candidate tuberculosis vaccine is immunogenic with a clinically acceptable safety profile in healthy and Mycobacterium tuberculosis-infected adults. This phase II, observer-blind, randomised study compared safety, reactogenicity, immunogenicity of 3 cohorts: tuberculosis-naïve adults (n = 80), previously treated for 49), who completed intensive treatment 13). In each cohort, 18-59-year-old were (1:1) to receive two doses 71) or placebo...
A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5–17 months) and 6537 infants 6–12 weeks) were 1:1:1-randomized to receive 4 doses of (R3R) or non-malaria control (C3C), 3 plus (R3C). Aggregate data reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral [CM]) gender-specific...
Background Plasmodium falciparum Apical Membrane Antigen 1 (PfAMA1) is a candidate vaccine antigen expressed by merozoites and sporozoites. It plays key role in red blood cell hepatocyte invasion that can be blocked antibodies. Methodology/Principal Findings We assessed the safety immunogenicity of recombinant PfAMA1 dose-escalating, phase Ia trial. FVO strain, produced Pichia pastoris, was reconstituted at 10 µg 50 doses with three different adjuvants, Alhydrogel™, Montanide ISA720 AS02...
The target delivery channel of RTS,S candidate malaria vaccines in malaria-endemic countries Africa is the World Health Organisation Expanded Program on Immunization. As an Adjuvant System, age de-escalation and schedule selection step, this study assessed 3 schedules RTS,S/AS01(E) RTS,S/AS02(D) infants young children 5-17 months Ghana.A Phase II, partially-blind randomized controlled (blind to vaccine, not schedule), 19 duration was conducted two (2) centres Ghana between August 2006 May...
GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative are working in partnership to develop a malaria vaccine protect infants children living endemic regions of sub-Saharan Africa, which can be delivered through Expanded Programme on Immunization. The RTS,S/AS candidate has been evaluated multiple phase I/II studies shown have favourable safety profile well-tolerated both adults children. This paper details design III multicentre efficacy trial RTS,S/AS01 candidate, is pivotal...
This phase II, randomized, double-blind study evaluated the immunogenicity of RTS,S vaccines containing Adjuvant System AS01 or AS02 as compared with non-adjuvanted in healthy, malaria-naïve adults (NCT00443131). Thirty-six subjects were randomized (1:1:1) to receive RTS,S/AS01, RTS,S/AS02, RTS,S/saline at months 0, 1, and 2. Antibody responses Plasmodium falciparum circumsporozoite (CS) hepatitis B surface (HBs) antigens assessed cell-mediated immune by flow cytometry using intracellular...