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  1. Article ; Online: Global regulatory agility during covid-19 and other health emergencies.

    Mak, Tippi K / Lim, John Cw / Thanaphollert, Prapassorn / Mahlangu, Gugu N / Cooke, Emer / Lumpkin, Murray M

    BMJ (Clinical research ed.)

    2020  Volume 369, Page(s) m1575

    MeSH term(s) Betacoronavirus ; COVID-19 ; Civil Defense ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Global Health ; Government Regulation ; Humans ; Interinstitutional Relations ; Internationality ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Resource Allocation ; SARS-CoV-2 ; World Health Organization
    Keywords covid19
    Language English
    Publishing date 2020-04-27
    Publishing country England
    Document type Editorial
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.m1575
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  2. Article: Global regulatory agility during covid-19 and other health emergencies

    Mak, Tippi K / Lim, John Cw / Thanaphollert, Prapassorn / Mahlangu, Gugu N / Cooke, Emer / Lumpkin, Murray M

    BMJ

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #125430
    Database COVID19

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  3. Article ; Online: Prevention and control of dengue-the light at the end of the tunnel.

    Pang, Tikki / Mak, Tippi K / Gubler, Duane J

    The Lancet. Infectious diseases

    2017  Volume 17, Issue 3, Page(s) e79–e87

    Abstract: Advances in the development of new dengue control tools, including vaccines and vector control, herald a new era of desperately needed dengue prevention and control. The burden of dengue has expanded for decades, and now affects more than 120 countries. ... ...

    Abstract Advances in the development of new dengue control tools, including vaccines and vector control, herald a new era of desperately needed dengue prevention and control. The burden of dengue has expanded for decades, and now affects more than 120 countries. Complex, large-scale global forces have and will continue to contribute to the expansion of dengue, including population growth, unplanned urbanisation, and suboptimal mosquito control in urban centres. Although no so-called magic bullets are available, there is new optimism following the first licensure of a dengue vaccine and other promising vaccine candidates, and the development of novel vector control interventions to help control dengue and other expanding mosquito-borne diseases such as Zika virus. Implementation of effective and sustainable immunisation programmes to complement existing methods will add complexity to the health systems of affected countries, which have varying levels of robustness and maturity. Long-term high prioritisation and adequate resources are needed. The way forward is full commitment to addressing a complex disease with a set of solutions integrating vaccination and vector control methods. A whole systems approach is thus needed to integrate these various approaches and strategies for controlling dengue within the goal of universal health coverage. The ultimate objective of these interventions will be to reduce the disease burden in a sustainable and equitable manner.
    MeSH term(s) Animals ; Dengue/drug therapy ; Dengue/prevention & control ; Dengue Vaccines/administration & dosage ; Dengue Vaccines/immunology ; Dengue Virus/immunology ; Humans ; Immunization Programs ; Insect Vectors/virology ; Mosquito Control/methods ; Public Health ; Vaccination
    Chemical Substances Dengue Vaccines
    Language English
    Publishing date 2017-03
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(16)30471-6
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  4. Book ; Online: Global regulatory agility during covid-19 and other health emergencies

    Mak, Tippi K / Lim, John CW / Thanaphollert, Prapassorn / Mahlangu, Gugu N / Cooke, Emer / Lumpkin, Murray M

    2020  

    Keywords EDITORIALS ; covid19
    Language English
    Publishing date 2020-04-27 03:15:33.0
    Publisher BMJ Publishing Group Ltd
    Publishing country us
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Global regulatory agility during covid-19 and other health emergencies

    Mak, Tippi K / Lim, John CW / Thanaphollert, Prapassorn / Mahlangu, Gugu N / Cooke, Emer / Lumpkin, Murray M

    BMJ

    2020  , Page(s) m1575

    Keywords covid19
    Language English
    Publisher BMJ
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.m1575
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial.

    Muangnoicharoen, Sant / Wiangcharoen, Rakpong / Nanthapisal, Sira / Kamolratakul, Supitcha / Lawpoolsri, Saranath / Jongkaewwattana, Anan / Thitithanyanont, Arunee / Luvira, Viravarn / Chinwangso, Pailinrut / Thanthamnu, Narumon / Chantratita, Narisara / Lim, Jacqueline Kyungah / Anh Wartel, T / Excler, Jean-Louis / Ryser, Martin F / Leong, Chloe / Mak, Tippi K / Pitisuttithum, Punnee

    Vaccine

    2023  Volume 41, Issue 32, Page(s) 4648–4657

    Abstract: Background: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and ... ...

    Abstract Background: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented.
    Methods: This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10
    Results: Solicited local and systemic adverse events (AEs) on days 0-7 were mostly mild, as were unsolicited vaccine-related AEs during days 0-28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell-produced interferon-γ increased approximately 10-fold in both groups.
    Conclusions: A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups.
    Clinical trials registration: NCT05109559.
    MeSH term(s) Adult ; Humans ; COVID-19/prevention & control ; SARS-CoV-2 ; COVID-19 Vaccines/adverse effects ; Ad26COVS1 ; Vaccines ; Antibodies, Neutralizing ; Antibodies, Viral ; Immunogenicity, Vaccine
    Chemical Substances BIBP COVID-19 vaccine ; COVID-19 Vaccines ; Ad26COVS1 (JT2NS6183B) ; Vaccines ; Antibodies, Neutralizing ; Antibodies, Viral
    Language English
    Publishing date 2023-06-15
    Publishing country Netherlands
    Document type Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2023.06.043
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  7. Article ; Online: Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial

    Muangnoicharoen, Sant / Wiangcharoen, Rakpong / Nanthapisal, Sira / Kamolratakul, Supitcha / Lawpoolsri, Saranath / Jongkaewwattana, Anan / Thitithanyanont, Arunee / Luvira, Viravarn / Chinwangso, Pailinrut / Thanthamnu, Narumon / Chantratita, Narisara / Lim, Jacqueline Kyungah / Anh Wartel, T. / Excler, Jean-Louis / Ryser, Martin F. / Leong, Chloe / Mak, Tippi K. / Pitisuttithum, Punnee

    Vaccine. 2023 July, v. 41, no. 32 p.4648-4657

    2023  

    Abstract: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity ... ...

    Abstract The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented. This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10¹⁰ virus particles) 90–240 days (Group A1; n = 360) or 45–75 days (Group A2; n = 66) after the second BBIBP-CorV dose. Safety and immunogenicity were assessed over 28 days. Binding IgG antibodies to the full-length pre-fusion Spike and anti-nucleocapsid proteins of SARS-CoV-2 were measured by enzyme-linked immunosorbent assay. The SARS-CoV-2 pseudovirus neutralization assay and live virus microneutralization assay were used to quantify the neutralizing activity of antibodies against ancestral SARS-CoV-2 (Wuhan-Hu-1) and the delta (B.1.617.2) and omicron (B.1.1.529/BA.1 and BA.2) variants. The cell-mediated immune response was measured using a quantitative interferon (IFN)-γ release assay in whole blood. Solicited local and systemic adverse events (AEs) on days 0–7 were mostly mild, as were unsolicited vaccine-related AEs during days 0–28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell–produced interferon-γ increased approximately 10-fold in both groups. A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups. Clinical Trials Registration. NCT05109559.
    Keywords COVID-19 infection ; Severe acute respiratory syndrome coronavirus 2 ; blood ; cell-mediated immunity ; enzyme-linked immunosorbent assay ; immunogenicity ; interferons ; neutralization tests ; vaccination ; vaccines ; viruses ; Thailand ; COVID-19 ; SARS-CoV-2 ; Whole inactivated virus vaccine ; Variants of concern ; Ad26.COV2.S ; Heterologous booster ; Neutralizing antibodies ; Delta ; Omicron
    Language English
    Dates of publication 2023-07
    Size p. 4648-4657.
    Publishing place Elsevier Ltd
    Document type Article ; Online
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2023.06.043
    Database NAL-Catalogue (AGRICOLA)

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  8. Article ; Online: Pandemic H1N1 infection in pregnant women in the USA.

    Mangtani, Punam / Mak, Tippi K / Pfeifer, Dina

    Lancet (London, England)

    2009  Volume 374, Issue 9688, Page(s) 429–430

    MeSH term(s) Disease Outbreaks ; Female ; Humans ; Influenza A Virus, H1N1 Subtype ; Influenza, Human/epidemiology ; Influenza, Human/virology ; Pregnancy ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/virology ; United States/epidemiology
    Language English
    Publishing date 2009-08-08
    Publishing country England
    Document type Comment ; Journal Article
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(09)61431-8
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  9. Article ; Online: Making BCG vaccination programmes safer in the HIV era.

    Mak, Tippi K / Hesseling, Anneke C / Hussey, Gregory D / Cotton, Mark F

    Lancet (London, England)

    2008  Volume 372, Issue 9641, Page(s) 786–787

    MeSH term(s) AIDS-Related Opportunistic Infections/prevention & control ; BCG Vaccine ; Humans ; Infant, Newborn ; Risk Assessment ; Tuberculosis/prevention & control
    Chemical Substances BCG Vaccine
    Language English
    Publishing date 2008-09-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(08)61318-5
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  10. Article: Influenza vaccination in pregnancy: current evidence and selected national policies.

    Mak, Tippi K / Mangtani, Punam / Leese, Jane / Watson, John M / Pfeifer, Dina

    The Lancet. Infectious diseases

    2008  Volume 8, Issue 1, Page(s) 44–52

    Abstract: In several countries, pregnant women are recommended seasonal influenza vaccination and identified as a priority group for vaccination in the event of a pandemic. We review the evidence for the risks of influenza and the risks and benefits of seasonal ... ...

    Abstract In several countries, pregnant women are recommended seasonal influenza vaccination and identified as a priority group for vaccination in the event of a pandemic. We review the evidence for the risks of influenza and the risks and benefits of seasonal influenza vaccination in pregnancy. Data on influenza vaccine safety in pregnancy are inadequate, but the few published studies report no serious side-effects in women or their infants, including no indication of harm from vaccination in the first trimester. National policies differ widely, mainly because of the limited data available, particularly on vaccination in the first trimester. The evidence of excess morbidity during seasonal influenza supports vaccinating healthy pregnant women in the second or third trimester and those with comorbidities in any trimester. The evidence of excess mortality in two previous influenza pandemics supports vaccinating in any trimester during a pandemic.
    MeSH term(s) Disease Outbreaks ; Female ; Health Policy ; Humans ; Infant, Newborn ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/adverse effects ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Influenza, Human/virology ; Pregnancy/immunology ; Pregnancy Complications, Infectious/prevention & control ; Pregnancy Outcome ; Pregnancy Trimesters ; Risk Assessment ; United Kingdom/epidemiology
    Chemical Substances Influenza Vaccines
    Language English
    Publishing date 2008-01
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(07)70311-0
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