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Article ; Online: Bringing Preventive RSV Monoclonal Antibodies to Infants in Low- and Middle-Income Countries

Jintanat Ananworanich / Penny M. Heaton

Vaccines, Vol 9, Iss 961, p

Challenges and Opportunities

2021 Volume 961

Abstract: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections (LRTIs) in infants. Most deaths occur in infants under 3 months old, and those living in low and middle-income countries (LMICs). There are no maternal or ... ...

Abstract	Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections (LRTIs) in infants. Most deaths occur in infants under 3 months old, and those living in low and middle-income countries (LMICs). There are no maternal or infant RSV vaccines currently approved. An RSV monoclonal antibody (mAb) could fill the gap until vaccines are available. It could also be used when a vaccine is not given, or when there is insufficient time to vaccinate and generate an antibody response. The only currently approved RSV mAb, palivizumab, is too costly and needs monthly administration, which is not possible in LMICs. It is imperative that a safe, effective, and affordable mAb to prevent severe RSV LRTI be developed for infants in LMICs. Next generation, half-life extended mAbs in clinical development, such as nirsevimab, show promise in protecting infants against RSV LRTI. Given that a single dose could cover an entire 5-month season, there is an opportunity to make RSV mAbs affordable for LMICs by investing in improvements in manufacturing efficiency. The challenges of using RSV mAbs in LMICs are the complexities of integrating them into existing healthcare delivery programs and surveillance systems, both of which are needed to define seasonal patterns, and monitor for escape mutants. Collaboration with key stakeholders such as the World Health Organization and Gavi, the Vaccine Alliance, will be essential for achieving this goal.
Keywords	RSV ; lower respiratory tract infection ; monoclonal antibody ; LMIC ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: HIV cure research

Jintanat Ananworanich / Anthony S. Fauci

Journal of Virus Eradication, Vol 1, Iss 1, Pp 1-

a formidable challenge

2015 Volume 3

Abstract: The ultimate goal of HIV cure research is to allow HIV-infected individuals to be free of disease in the absence of antiretroviral therapy. We discuss current directions and future opportunities aimed at achieving sustained virological remission, and ... ...

Abstract	The ultimate goal of HIV cure research is to allow HIV-infected individuals to be free of disease in the absence of antiretroviral therapy. We discuss current directions and future opportunities aimed at achieving sustained virological remission, and possibly eradication. A multidisciplinary approach to HIV cure research will be important, and ethical, social and behavioural research should be conducted in parallel with basic and clinical research.
Keywords	Microbiology ; QR1-502 ; Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: How Much HIV is Alive? The Challenge of Measuring Replication Competent HIV for HIV Cure Research

Jintanat Ananworanich / John W. Mellors

EBioMedicine, Vol 2, Iss 8, Pp 788-

2015 Volume 789

Keywords	Medicine ; R ; Medicine (General) ; R5-920
Language	English
Publishing date	2015-08-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The transient HIV remission in the Mississippi baby

Jintanat Ananworanich / Merlin L Robb

Journal of the International AIDS Society , Vol 17, Iss 1, Pp 1-

why is this good news?

2014 Volume 2

Keywords	General Works ; A ; Medicine ; R ; Political science ; J ; Social Sciences ; H ; Immunologic diseases. Allergy ; RC581-607
Language	English
Publishing date	2014-11-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults

Ivan T. Lee / Raffael Nachbagauer / David Ensz / Howard Schwartz / Lizbeth Carmona / Kristi Schaefers / Andrei Avanesov / Daniel Stadlbauer / Carole Henry / Ren Chen / Wenmei Huang / Daniela Ramirez Schrempp / Jintanat Ananworanich / Robert Paris

Nature Communications, Vol 14, Iss 1, Pp 1-

interim analysis

2023 Volume 11

Abstract: Abstract Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent ... ...

Abstract	Abstract Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010.
Keywords	Science ; Q
Subject code	610
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Is there gender bias in HIV cure research? A case study of female representation at the 2015 HIV Persistence Workshop

Rowena Johnston / Suteeraporn Pinyakorn / Jintanat Ananworanich

Journal of Virus Eradication, Vol 2, Iss 2, Pp 117-

2016 Volume 120

Keywords	Microbiology ; QR1-502 ; Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2016-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Parallel but connected

Gail E. Henderson / Stuart Rennie / Amy Corneli / Karen Meagher / R. Jean Cadigan / Eugène Kroon / Jintanat Ananworanich / Holly L. Peay

Contemporary Clinical Trials Communications, Vol 19, Iss , Pp 100594- (2020)

Nuances of conducting behavioral and social science research alongside ethically challenging HIV remission trials

2020

Abstract: Collaborations between clinical investigators and behavioral and social science researchers (BSSR) produce many benefits, but also may generate challenges and complexities. Ongoing relationships between teams may affect the research carried out by the ... ...

Abstract	Collaborations between clinical investigators and behavioral and social science researchers (BSSR) produce many benefits, but also may generate challenges and complexities. Ongoing relationships between teams may affect the research carried out by the BSSR team and the way they interpret their findings. Here we describe our experiences conducting the HIV Remission (‘Cure’) Trials Decision-Making Study (DMS), in Thailand; these trials include potentially risky interventions and interruption of standard antiretroviral treatment, with little personal benefit. The DMS is a longitudinal study of the experiences of individuals recruited to such early-phase trials, and conducted alongside these trials. It originated in clinical investigators' concerns about the ability of those recruited to make voluntary and informed decisions about scientifically complex studies, and is led by an independent group of BSSR and ethics researchers. In conducting this study, we experienced three overarching challenges to achieving a successful and dynamic collaboration: managing emerging findings as data were collected alongside clinical trial participation; evolving interconnectedness and shifting partnership boundaries among investigators; and the process of incorporating new research questions. By describing these challenges, we provide experiential evidence on how to manage multidimensional aspects of these collaborations. We describe how our research teams came together as well as the challenges and opportunities we experienced along the way. Our aim is to raise awareness of the scientific, practical, and ethical complexities of establishing and maintaining this kind of broad multidisciplinary collaboration over time. By describing our experiences, we hope to advance an agenda for others who undertake similar partnerships.
Keywords	Medicine (General) ; R5-920
Subject code	170 ; 306
Language	English
Publishing date	2020-09-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Clinical outcome of HIV viraemic controllers and noncontrollers with normal CD4 counts is exclusively determined by antigen-specific CD8+ T-cell-mediated HIV suppression.

Yada Tansiri / Sarah L Rowland-Jones / Jintanat Ananworanich / Pokrath Hansasuta

PLoS ONE, Vol 10, Iss 3, p e

2015 Volume 0118871

Abstract: In this cross-sectional study we evaluated T-cell responses using several assays to determine immune correlates of HIV control that distinguish untreated viraemic controllers (VC) from noncontrollers (NC) with similar CD4 counts. Samples were taken from ... ...

Abstract	In this cross-sectional study we evaluated T-cell responses using several assays to determine immune correlates of HIV control that distinguish untreated viraemic controllers (VC) from noncontrollers (NC) with similar CD4 counts. Samples were taken from 65 ART-naïve chronically HIV-infected VC and NC from Thailand with matching CD4 counts in the normal range (>450 cells/μl). We determined HIVp24-specific T-cell responses using standard Interferon-gamma (IFNγ) ELISpot assays, and compared the functional quality of HIVp24-specific CD8+ T-cell responses using polychromatic flow cytometry. Finally, in vitro HIV suppression assays were performed to evaluate directly the activity of CD8+ T cells in HIV control. Autologous CD4+ T cells were infected with primary patient-derived HIV isolates and the HIV suppressive activity of CD8+ T cells was determined after co-culture, measuring production of HIVp24 Ag by ELISA. The HIVp24-specific T-cell responses of VC and NC could not completely be differentiated through measurement of IFNγ-producing cells using ELISpot assays, nor by the absolute cell numbers of polyfunctional HIVp24-specific CD8+ T cells. However, in vitro HIV suppression assays showed clear differences between VC and NC. HIV suppressive activity, mediated by either ex vivo unstimulated CD8+ T cells or HIVp24-specific T-cell lines, was significantly greater using cells from VC than NC cells. Additionally, we were able to demonstrate a significant correlation between the level of HIV suppressive activity mediated by ex vivo unstimulated CD8+ T cells and plasma viral load (pVL) (Spearman r = -0.7345, p = 0.0003). This study provides evidence that in vitro HIV suppression assays are the most informative in the functional evaluation of CD8+ T-cell responses and can distinguish between VC and NC.
Keywords	Medicine ; R ; Science ; Q
Subject code	570
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prices of second-line antiretroviral treatment for middle-income countries inside versus outside sub-Saharan Africa

Bryony Simmons / Andrew Hill / Nathan Ford / Kiat Ruxrungtham / Jintanat Ananworanich

Journal of the International AIDS Society , Vol 17, Iss 4(Suppl 3), Pp 1-

2014 Volume 1

Abstract: Introduction: Antiretrovirals are available at low prices in sub-Saharan Africa, but these prices may not be consistently available for middle-income countries in other regions with large HIV epidemics. Over 30% of HIV infected people live in countries ... ...

Abstract	Introduction: Antiretrovirals are available at low prices in sub-Saharan Africa, but these prices may not be consistently available for middle-income countries in other regions with large HIV epidemics. Over 30% of HIV infected people live in countries outside sub-Saharan Africa. Several key antiretrovirals are still on patent, with generic production restricted. We assessed price variations for key antiretroviral drugs inside versus outside sub-Saharan Africa. Methods: HIV drug prices used in national programmes (2010–2014) were extracted from the WHO Global Price Reporting Mechanism database for all reporting middle-income countries as classified by the World Bank. Treatment costs (branded and generic) were compared for countries inside sub-Saharan Africa versus those outside. Five key second-line antiretrovirals were analysed: abacavir, atazanavir, darunavir, lopinavir/ritonavir, raltegravir. Results: Prices of branded antiretrovirals were significantly higher outside sub-Saharan Africa (p<0.001, adjusted for year of purchase) (see Table 1). For example, the median (interquartile range) price of darunavir from Janssen was $732 (IQR $732-806) per person-year in sub-Saharan Africa versus $4689 (IQR $4075-5717) in non-African middle-income countries, an increase of 541%. However, when supplied by generic companies, most antiretrovirals were similarly priced between countries in sub-Saharan Africa and other regions. Conclusions: Pharmaceutical companies are selling antiretrovirals to non-African middle-income countries at prices 74–541% higher than African countries with similar gross national incomes. However, generic companies are selling most of these drugs at similar prices across regions. Mechanisms to ensure fair pricing for patented antiretrovirals across both African and non-African middle-income countries need to be improved, to ensure sustainable treatment access.
Keywords	General Works ; A ; Medicine ; R ; Political science ; J ; Social Sciences ; H ; Immunologic diseases. Allergy ; RC581-607
Subject code	339
Language	English
Publishing date	2014-11-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Characteristics of suboptimal immune response after initiating antiretroviral therapy among people living with HIV with a pre-treatment CD4 T cell count <200 cells/mm3 in Thailand

Win Min Han / Sasiwimol Ubolyam / Tanakorn Apornpong / Stephen J. Kerr / Pokrath Hansasuta / Sivaporn Gatechompol / Wirach Maekanantawat / Kiat Ruxrungtham / Praphan Phanuphak / Jintanat Ananworanich / Anchalee Avihingsanon

Journal of Virus Eradication, Vol 6, Iss 3, Pp 100005- (2020)

2020

Abstract: Background: Complete recovery of the CD4 T cell count is uncommon among chronically HIV-infected individuals with very low pre-treatment CD4 count. We studied the prevalence of chronically immune recovery and its associated factors including immune ... ...

Abstract	Background: Complete recovery of the CD4 T cell count is uncommon among chronically HIV-infected individuals with very low pre-treatment CD4 count. We studied the prevalence of chronically immune recovery and its associated factors including immune characteristics chronic HIV-infected Thais. Methods: Treatment-naïve participants (n = 375) from the HIV-NAT 006 cohort with a pre-treatment CD4 T cell count after initiating antiretroviral therapy (ART) and having achieved a suppressed viremia (HIV-RNA level < 400 copies/mL) were retrospectively followed at the Thai Red Cross AIDS Research Centre, Bangkok, Thailand. Suboptimal immune recovery (SIR) was defined as having a CD4+ T cell count <200 cells/mm3 for 3 years after ART initiation. A case-control sub-study matched for age, sex and pre-ART CD4 T cell count was conducted to compare immunological characteristics between SIR (n = 17) and non-SIR (n = 24) participants. Immunological biomarkers such as interleukin-7 (IL-7) and soluble CD14 (sCD14) and other covariates including cytomegalovirus (CMV) DNA level, baseline hemoglobin level, hepatitis B and C co-infections, and T cell subsets associated with immune activation and exhaustion were evaluated. Results: Among 375 participants with pre-ART CD4 T cell counts < 200 cells/mm3, the prevalence of SIR was 39.7%, 19.7% and 7.7% at years 1, 2 and 3 after starting ART, respectively. In a multivariate analysis, a pre-ART CD4 T cell count ≤100 cells/mm3 (adjusted odds ratio [aOR] 9.45, 95% CI 2.92–30.61, p < 0.001), older age (aOR 1.07, 95% CI 1.01–1.13, p = 0.029) and baseline HIV-RNA level (aOR 0.36, 95% CI 0.21–0.59, p < 0.001) were independently associated with SIR at year 3 after ART initiation. In the matched case-control sub-study (cases = 17, controls = 24), there was a higher prevalence of hepatitis C co-infection (18.8% vs. 0%, p = 0.05), lower sCD14 levels (mean, 6.23 vs. 6.27 log10 pg/mL, p = 0.04), lower CD8 T cell counts (mean, 514 vs. 876, p = 0.0003), lower CD4/CD8 T cell ratio (mean, 0.27 ...
Keywords	Suboptimal immune recovery ; Immune characteristics ; Antiretroviral treatment ; Asian ; Microbiology ; QR1-502 ; Public aspects of medicine ; RA1-1270
Subject code	570
Language	English
Publishing date	2020-09-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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