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Cold Chain-Independent, Needle-Free Mucosal Virosomal Vaccine to Prevent HIV-1 Acquisition at Mucosal Levels

Award Number: U19AI142636
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY – OVERALL This multi-PI application is a collaboration between Mymetics and the Texas Biomedical Research Institute (TxBiomed), with Drs. Sylvain Fleury (Project 1 Lead; Mymetics) and Ruth Ruprecht (Project 2 Lead; TxBiomed) serving as PIs. We seek to bring a promising HIV/AIDS vaccine approach to the clinic. The vaccine is based upon influenza virosomes, enveloped virus-like particles that display on their surface elongated HIV gp41 peptides (virosome-P1) or recombinant truncated HIV gp41 (virosome-rgp41). Mymetics' Phase I clinical trial with virosome-P1 in healthy women showed safety and immunogenicity. Two independent nonhuman primate (NHP) studies demonstrated the safety and high efficacy of the combination of virosome-P1 + virosome rgp41 against repeated low-dose intravaginal challenges with a tier 2 R5 SHIV in Chinese and Indian-origin rhesus macaques (RMs). In the latter, 78-87% efficacy was noted when the SHIV challenge dose was ~7x104 times the median HIV inoculum in male-to-female HIV transmission. However, when this HIV inoculum was exceeded 105- fold by an even higher SHIV inoculum, protection in Indian RMs was lost, implying a threshold effect whereby vaccine-induced mucosal antibodies were unable to ward off the higher number of invading SHIV particles. The soluble vaccine used in both NHP studies was unadjuvanted. To improve immunogenicity, Mymetics has embedded the toll-like receptor (TLR)7/8 adjuvant 3M-052 into virosomal envelopes. Moreover, Mymetics has developed a powdered form of virosomes that is no longer cold-chain dependent and can be administered as intranasal (IN) spray, sublingual (SL) tablets, or packaged into oral capsules. We hypothesize that these novel solid virosome formulations are significantly more immunogenic, particularly when administered via mucosal routes, than the unadjuvanted liquid form used earlier in NHPs. The Specific Aims of this IPCAVD project are to: 1. Assess the immunogenicity of the new vaccine candidates, the newly 3M-052-adjuvanted HIV virosome-P1 and virosome-rgp41, under solid dosage forms delivered IN, SL, or orally to Indian RMs in order to select the two most immunogenic formulations for subsequent mucosal prime/mucosal boost immunization. 2. Assess the efficacy of the cold-chain independent virosomal vaccine delivered by combined mucosal immunization routes against repeated intrarectal challenges with the heterologous R5 clade B SHIVSF162P3. Protected RMs will be rechallenged with an R5 tier 2 clade C SHIV. 3. Optimize the GMP manufacturing process for the selected virosomal formulations for mucosal delivery, and 4. Perform toxicology studies to show good safety profiles of the adjuvanted, solid-form vaccines given by selected mucosal routes – and generate GMP vaccine for a Phase I trial to be conducted with the HVTN. Our vaccine development plans represent major advances, as the novel needle-free, solid vaccine dosage forms are cold-chain independent and will be mucosally delivered – unique aspects that make the novel virosomal vaccines especially attractive for the developing world, where the AIDS epidemic remains a serious problem.


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: 2023 ( Subtotal = $1,629,815 )
2023	2023	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	001	6	5/17/2023	NON-COMPETING CONTINUATION	$1,629,815
2023	2023	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	002	6	8/16/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	000	5	4/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,629,815

Issue Date FY: 2022 ( Subtotal = $1,615,853 )
2022	2022	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	000	5	5/19/2022	NON-COMPETING CONTINUATION	$1,615,853
2022	2022	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	001	5	8/25/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,615,853

Issue Date FY: 2021 ( Subtotal = $1,719,534 )
2021	2021	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	001	4	5/5/2021	NON-COMPETING CONTINUATION	$1,719,534
2021	2020	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	000	3	11/18/2020	NON-COMPETING CONTINUATION	$0
2021	2020	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	002	3	5/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,719,534

Issue Date FY: 2020 ( Subtotal = $1,855,534 )
2020	2020	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	004	3	7/8/2020	NON-COMPETING CONTINUATION	$200,416
2020	2020	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	002	3	5/4/2020	NON-COMPETING CONTINUATION	$1,855,534
2020	2020	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	005	3	7/8/2020	NON-COMPETING CONTINUATION	-$200,416
2020	2019	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	006	2	7/8/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$200,416
2020	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	000	1	1/31/2020	NEW	-$727,169
2020	2019	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	001	2	2/1/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$727,169
2020	2019	UNIVERSITY OF LOUISIANA AT LAFAYETTE	104 E UNIVERSITY CIR 3RD FL	LAFAYETTE	LA	70503	LAFAYETTE	USA	Allergy and Infectious Diseases Research	008	2	7/27/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$1,831
2020	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	007	1	7/27/2020	NEW	$1,831
2020	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	003	1	7/8/2020	NEW	-$200,416
														Subtotal = $1,855,534

Issue Date FY: 2019 ( Subtotal = $1,940,385 )
2019	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	002	1	9/19/2019	NEW	$0
2019	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	001	1	5/2/2019	NEW	$0
2019	2019	TEXAS BIOMEDICAL RESEARCH INSTITUTE	8715 W MILITARY DR	SAN ANTONIO	TX	78227	BEXAR	USA	Allergy and Infectious Diseases Research	000	1	4/22/2019	NEW	$1,940,385
														Subtotal = $1,940,385

Grand Total All Awards = $8,761,121

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Cold Chain-Independent, Needle-Free Mucosal Virosomal Vaccine to Prevent HIV-1 Acquisition at Mucosal Levels

Award Number: U19AI142636

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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