Publications by authors named "Lulu Bravo"

Background: Though observational evidence supports indirect effects of SARS-CoV-2 vaccines, randomised experiments are lacking. To address this gap, the double-blinded, prospective follow-up of the household contacts (HHCs) of Philippine participants of the individually-randomised, placebo-controlled trial of the adjuvanted-subunit protein COVID-19 vaccine, SCB-2019, (EudraCT, 2020-004272-17; ClinicalTrials.gov, NCT04672395) was analyzed in a cluster-randomised fashion.

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Article Synopsis
  • The study investigated how previous vaccinations for Yellow Fever (YF) and Japanese Encephalitis (JE) affect the effectiveness of the dengue vaccine candidate, TAK-003, in children aged 4-16 years.
  • Out of 20,071 participants, different levels of vaccine efficacy were observed: 55.7% in those previously vaccinated for YF, 77.8% for JE, and 53.5% for those with no prior vaccinations, but these results were influenced by the regional distribution of dengue virus serotypes.
  • Overall, the findings indicate that prior YF or JE vaccinations do not significantly impact the efficacy of TAK-003, which was well-tolerated across various epidemiological settings.
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The 6th Asia Dengue Summit (ADS) themed "Road Map to Zero Dengue Death" was held in Thailand from 15th-16th June 2023. The summit was hosted by Tropical Medicine Cluster, Chulalongkorn University, Bangkok, Thailand in conjunction with Queen Saovabha Memorial Institute, The Thai Red Cross Society; Faculty of Tropical Medicine, Mahidol University; and the Ministry of Public Health. The 6th ADS was convened by Asia Dengue Voice and Action (ADVA); Global Dengue and Aedes Transmitted Diseases Consortium (GDAC); Southeast Asian Ministers of Education Tropical Medicine and Public Health Network (SEAMEO TROPMED); Fondation Mérieux (FMx) and the International Society for Neglected Tropical Diseases (ISNTD).

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Article Synopsis
  • About half of the global population lives in areas where dengue fever is common, leading researchers to test the tetravalent dengue vaccine TAK-003 for its long-term effectiveness in children and adolescents aged 4-16.
  • The study is a double-blind, placebo-controlled trial conducted across eight dengue-endemic countries, enrolling over 20,000 participants, and focusing on the vaccine's ability to prevent symptomatic dengue disease.
  • Results will be evaluated over approximately 4.5 years, monitoring both efficacy and the incidence of serious adverse events, with ongoing oversight to ensure participant safety.
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  • Immunobridging is a method used to figure out how well vaccines work for people who weren’t tested in clinical studies, and it's helped create many vaccines.
  • Dengue is a virus spread by mosquitoes that used to mainly affect kids, but now it's a risk for both kids and adults around the world.
  • A study showed that the dengue vaccine (TAK-003) was tested on kids and found to work similarly in adults, suggesting it could be effective for everyone.
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  • SCB-2019, a COVID-19 vaccine candidate, was tested in a study involving 1,278 healthy adolescents aged 12-17 across Belgium, Colombia, and the Philippines to evaluate its immunogenicity and safety compared to placebo.
  • The vaccine showed strong immunogenicity, with neutralizing antibody levels in adolescents comparable to those in young adults, particularly for those previously exposed to SARS-CoV-2.
  • The SCB-2019 vaccine was well tolerated, with mild to moderate side effects that were similar between adolescents receiving the vaccine and those given a placebo, except for more reported injection site pain in the vaccine group.
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The 5th Asia Dengue Summit, themed "Roll Back Dengue", was held in Singapore from 13 to 15 June 2022. The summit was co-convened by Asia Dengue Voice and Action (ADVA), Global Dengue and Aedes transmitted Diseases Consortium (GDAC), Southeast Asian Ministers of Education Tropical Medicine and Public Health Network (SEAMEO TROPMED), and the Fondation Mérieux (FMx). Dengue experts from academia and research and representatives from the Ministries of Health, Regional and Global World Health Organization (WHO), and International Vaccine Institute (IVI) participated in the three-day summit.

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Aiming to further the Immunization Partners in Asia Pacific (IPAP)'s vision of a world where no one suffers from a vaccine preventable disease, the 8 Asian Vaccine Conference (ASVAC 2022) was held in Colombo, Sri Lanka and virtually from 15 to 18, September 2022 (www.asianvaccine.com).

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Background: An exploratory household transmission study was nested in SPECTRA, the phase 2/3 efficacy study of the adjuvanted recombinant protein-based COVID-19 vaccine SCB-2019. We compared the occurrence of confirmed COVID-19 infections between households and household contacts of infected SPECTRA placebo or SCB-2019 recipients.

Methods: SPECTRA participants at 8 study sites in the Philippines who developed real-time reverse transcriptase-polymerase chain reaction (rRT-PCR)-confirmed COVID-19 were contacted by a study team blinded to assignment of index cases to vaccine or placebo groups to enroll in this household transmission study.

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Article Synopsis
  • The study evaluated the safety and efficacy of the SCB-2019 COVID-19 vaccine in a large, double-blind, placebo-controlled trial involving over 30,000 adults across five countries.* -
  • Participants were randomly assigned to receive either the vaccine or a placebo, and the primary focus was on measuring vaccine effectiveness against COVID-19 and monitoring adverse effects.* -
  • Results showed that the vaccine had an overall efficacy of 67.2% against any severity of COVID-19, and 83.7% efficacy against moderate-to-severe cases, indicating its potential effectiveness in preventing the disease.*
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Background: Cell-culture-derived influenza vaccines may enable a closer antigenic match to circulating strains of influenza virus by avoiding egg-adapted mutations.

Methods: We evaluated the efficacy of a cell-culture-derived quadrivalent inactivated influenza vaccine (IIV4c) using a Madin-Darby canine kidney cell line in children and adolescents 2 to less than 18 years of age. During three influenza seasons, participants from eight countries were enrolled in an observer-blinded, randomized clinical trial comparing IIV4c with a noninfluenza vaccine (meningococcal ACWY).

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Background: Takeda's live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data.

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Background: Noroviruses (NoVs) cause acute gastroenteritis (AGE) worldwide, affecting children in particular. We aimed to estimate the burden of disease due to NoV among children aged <6 years in Brazil, Chile, Philippines and Thailand.

Methods: This was a prospective, hospital-based, observational study.

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Background: A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative.

Methods: This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II).

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Background: Takeda's dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update.

Methods: Children (20 099, 4-16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR.

Results: Cumulative efficacy against dengue approximately 27 months since first dose was 72.

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Background: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years.

Methods: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand).

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The 7th Asian Vaccine Conference (ASVAC 2019) was held in Yangon, Myanmar from 13 to 15, September 2019. It brought together stakeholders in the field of vaccination to address challenges and issues relevant to clinical practice and immunization programs in the region. The conference themed "", included pre-conference workshops, a Vaccinology Masterclass, plenary lectures, symposia, and poster presentations.

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Background: A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV.

Methods: This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines.

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Background: Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.

Methods: We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart.

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Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.

Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons.

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Vaccines are among the most effective measures to control and prevent infectious diseases. Yet, the topic of vaccination is difficult to communicate, as it bears upon individual versus common good. The efficacy and safety of vaccines can only be shown by the absence of undesired events, such as vaccine-preventable diseases or adverse events following immunization.

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Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded.

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This literature analysis describes the available dengue epidemiology data in the Philippines between 2000 and 2011. Of 253 relevant data sources identified, 34, including additional epidemiology data provided by the National Epidemiology Center, Department of Health, Philippines, were reviewed. There were 14 publications in peer reviewed journals, and 17 surveillance reports/sources, which provided variable information from the passive reporting system and show broad trends in dengue incidence, including age group predominance and disease severity.

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