Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.

24 Jun 2024·JCI Insight

Innate protection against intrarectal SIV acquisition by a live SHIV vaccine

Article

Author: Li, Jianping ; Shen, Xiaoying ; Tomaras, Georgia D ; Breed, Matthew W ; Howe, Savannah E ; Sui, Yongjun ; Ma, Chi ; Berzofsky, Jay A ; Kramer, Josh A ; Cam, Maggie ; Meyer, Thomas J ; LaBranche, Celia C ; Dadkhah, Kimia ; Kelly, Michael C ; Miller, Christopher J ; Fennessey, Christine M ; Williams, LaTonya D ; Montefiori, David ; Greten, Tim F ; Ferrari, Guido ; Keele, Brandon F

Identifying immune correlates of protection is a major challenge in AIDS vaccine development. Anti-Envelope antibodies have been considered critical for protection against SIV/HIV (SHIV) acquisition. Here, we evaluated the efficacy of an SHIV vaccine against SIVmac251 challenge, where the role of antibody was excluded, as there was no cross-reactivity between SIV and SHIV envelope antibodies. After 8 low-dose intrarectal challenges with SIVmac251, 12 SHIV-vaccinated animals demonstrated efficacy, compared with 6 naive controls, suggesting protection was achieved in the absence of anti-envelope antibodies. Interestingly, CD8+ T cells (and some NK cells) were not essential for preventing viral acquisition, as none of the CD8-depleted macaques were infected by SIVmac251 challenges. Initial investigation of protective innate immunity revealed that protected animals had elevated pathways related to platelet aggregation/activation and reduced pathways related to interferon and responses to virus. Moreover, higher expression of platelet factor 4 on circulating platelet-leukocyte aggregates was associated with reduced viral acquisition. Our data highlighted the importance of innate immunity, identified mechanisms, and may provide opportunities for novel HIV vaccines or therapeutic strategy development.

30 Mar 2023·Journal of virology

The Failure of AIDS Vaccine Efficacy Trials: Where to Go from Here.

Article

Author: Desrosiers, Ronald C.

The seven AIDS vaccine efficacy trials have yielded extremely disappointing results at great expense. Greater stringency is needed for government support of AIDS vaccine efficacy trials.

100 Deals associated with AIDS vaccine (Medestea)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Discovery	IT	Medestea Internazionale Srl	05 Jan 2016

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2014	Not Applicable	HIV Infections	244	HIV vaccine (Participants with specified low-risk criteria)	izjqesmfko(ahectfpkrn) = jqpmehcrvt fgfrjlwbus (qicyqubgtf, 1.6 - 5.6)	-	01 Jan 2014
IAS2014	Not Applicable	HIV Infections	244	HIV vaccine (Participants without specified low-risk criteria)	izjqesmfko(ahectfpkrn) = mjkoiipfos fgfrjlwbus (qicyqubgtf, 0.3 - 4.0)	-	01 Jan 2014
IAS2006	Not Applicable	HIV Infections	1,200	HIV vaccine (Young people (<45 years))	mifignwmxf(mtrpmocrvp) = gigtqenzmt wjjakqwnna (uqpvtxqkbp, 1.0 - 2.8)	-	01 Jan 2006
VAX004 (IAS2006)	Not Applicable	-	37	Bivalent Glycoprotein (gp) 120 preventive HIV vaccine (High-risk uninfected women)	ujwjhiyhns(agaylkgdhr) = nlotlxwkpl obtsstogvn (jtimnhrcue, p=0.04)	-	01 Jan 2006
IAS2002	Not Applicable	Risk Reduction Behavior	-	HIV vaccine (AIDSVAX B/B)	dhxsdedcdq(uxstcbgotc) = xcwvuodqcg jdjtbizgzv (ziowdedbvk ) View more	-	01 Jan 2002
IAS2002	Not Applicable	Risk Reduction Behavior	-	Placebo	dhxsdedcdq(uxstcbgotc) = qfctkpnwir jdjtbizgzv (ziowdedbvk ) View more	-	01 Jan 2002

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