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An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIV

Award Number: R01AI150360
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIV - An Etonogestrel/Ethinyl Estradiol/QGriffithsin (EEQ) IVR to Prevent Pregnancy and HIV Several multipurpose prevention technologies (MPTs) have been advanced to prevent unintended pregnancy and HIV. The current MPT development pipeline is dominated by antiretroviral (ARV) products with progestin- only contraception using levonorgestrel. The Population Council, in collaboration with Oak Crest Institute of Science (OCIS), proposes to develop a 90d pod-type IVR containing the progestin etonogestrel (ETG), the estrogen ethinyl estradiol (EE), and the anti-HIV lectin QGriffithsin (QGRFT), hereafter referred to as the EEQ IVR, to prevent unintended pregnancy and HIV. This product offers a highly effective contraceptive combination (used in NuvaRing®) with the extremely potent and stable non-ARV anti-HIV lectin QGRFT. The EEQ IVR offers significant advantages over ARV/progestin-only contraceptive products. It could reduce both the emergence of drug-resistant HIV and the concern of potential increased risk of HIV transmission as well as common irregular bleeding complaints associated with use of a progestin-only contraceptive. Aim 1: The proposed product development plan for the EEQ IVR includes innovative formulation work involving pod IVR designs and the use of silk fibroin to achieve QGRFT release for 90d. We will develop a scalable process to manufacture an EEQ IVR. Aim 2: Two lead EEQ IVRs will be tested in safety/pharmacokinetics/pharmacodynamics studies in rhesus macaques (RMs). We intend that the EEQ IVR will be safe, deliver target API doses for 90d in vivo and demonstrate in vitro efficacy against HIV/SHIV AD8. Based on these studies, the lead RM IVR will be selected and advanced to in vivo efficacy studies in RMs. We postulate that the EEQ IVR will be efficacious against SHIV AD8 in vivo and will not drive resistance. Aim 3: We will conduct a pilot study among 24 US couples to compare adherence, preference and acceptability of 3 placebo silicone IVRs of different external diameters (46mm, 56mm and 66mm) to inform the design of the EEQ IVR. Using a 3-way crossover study design, we will identify the external IVR diameter associated with greatest adherence and preference to inform the final EEQ IVR design. The EEQ IVR has the potential to significantly improve women’s health and advance the MPT and drug delivery fields. The EEQ IVR would be the first non-ARV MPT for women at high risk for both unintended pregnancy and HIV acquisition.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $805,684 )
2024	2024	THE POPULATION COUNCIL, INC.	1 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	002	5	4/16/2024	NON-COMPETING CONTINUATION	$805,684
2024	2023	THE POPULATION COUNCIL, INC.	1 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	001	4	3/4/2024	NON-COMPETING CONTINUATION	$0
2024	2022	THE POPULATION COUNCIL, INC.	1 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	2/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $805,684

Issue Date FY: 2023 ( Subtotal = $857,028 )
2023	2023	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	3/1/2023	NON-COMPETING CONTINUATION	$857,028
														Subtotal = $857,028

Issue Date FY: 2022 ( Subtotal = $987,021 )
2022	2022	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	001	3	4/1/2022	NON-COMPETING CONTINUATION	$987,021
2022	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	10/12/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $987,021

Issue Date FY: 2021 ( Subtotal = $994,388 )
2021	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	4/16/2021	NON-COMPETING CONTINUATION	$994,388
														Subtotal = $994,388

Issue Date FY: 2020 ( Subtotal = $1,068,884 )
2020	2020	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	4/6/2020	NEW	$1,068,884
2020	2020	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Allergy and Infectious Diseases Research	001	1	5/5/2020	NEW	$0
														Subtotal = $1,068,884

Grand Total All Awards = $4,713,005

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An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIV

Award Number: R01AI150360

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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