Translating germline-targeting HIV ENV sosip immunization of infants: targeting bnabs in early life

Active Project Grant Awarded Last action

Award ID
P01AI189362
Recipient
Awarding agency
Obligated
$8,874,264

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 26% complete
Place of performance
New York, NY 10065, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Overall despite decades of research and millions of global infections and deaths, we remain without an effective vaccine against HIV. Traditional vaccine approaches have failed to induce broadly neutralizing antibodies (BNABS), crucial for protection against diverse HIV strains. The primary goal of next-generation HIV vaccines is to stimulate B cell lineages capable of producing BNABS. Recent successes in this realm involve structurally designed immunogens, such as the BG505 germline-targeting (GT1.1) HIV envelope sosip trimer, which mimics native viral envelope structures and engages bnab precursor lineages. While promising, achieving bnab responses in plasma, even at low levels, remains unachieved in the adult populations where IT has been tested. Children living with HIV exhibit faster development and more polyclonal bnab responses compared to adults, suggesting the potential success of early-life vaccination strategies targeting bnab responses. Our preclinical studies in nonhuman primates have indicated that infant rhesus macaques more frequently develop bnab precursor responses following BG505 GT1.1 sosip trimer immunization, with robust autologous virus neutralization and early evidence of heterologous virus neutralization in plasma. This vaccine has also shown promise in adult human clinical trials in eliciting "on target" vaccine responses, without any safety concerns. While the early life immune system may offer benefits to this vaccine regimen for achieving its immunologic goals, the dosing, intervals, and potential interactions with pre-existing antibodies and other childhood vaccines is unknown, limiting the development of an optimal infant phase 1 trial. Thus, this program aims to design and systematically test the optimal regimen of BG505 GT1.1 sosip trimer vaccine series as a safe and effective pediatric immunogen for eliciting lifelong bnab responses. Specific aims include: aim 1: determining the optimal pediatric formulation and dose, aim 2: aligning immunization intervals with childhood vaccine schedules and assessment of persistence of responses into adolescence, and aim 3: assessing the impact of maternal antibodies and passive immunization with BNABS on vaccine immunogenicity and efficacy. By leveraging preclinical models to assess safety, regimen, and persistence into adulthood, this program seeks to overcome regulatory hurdles that will pave the way for optimized infant HIV vaccine trials. Successful induction of BNABS via early-life vaccination could revolutionize HIV prevention efforts, offering hope for a future without the burden of the HIV epidemic.

Transactions

Action Obligated Date
Amendment $4,243,578
Original award $4,630,686

Subawards

Subrecipient Amount Awarded
Fred Hutchinson Cancer Research Center Dr. Holly Janes is an expert in the evaluation of vaccines and bnAbs for HIV prevention. As a co-investigator and Fred Hutch site project director/principal… $257,562
Duke University The objective of Dr. Wiehe’s work on this sub-award is to perform bioinformatic analysis of B cell receptor sequences from B cells elicited from immunized… $295,141
University Of California, Davis There is a continued urgent need for an HIV vaccine. Research indicates that an effective vaccine needs to elicit broadly neutralizing antibodies (bnAbs) that… $1,681,802
University Of North Carolina At Chapel Hill Dr. De Paris will serve as PI on the overall Program application, and therefore also act as Director of the Admistrative Core. In addition, Dr. De Paris will be… $343,288
University Of North Carolina At Chapel Hill Dr. De Paris will serve as PI on the overall Program application, and therefore also act as Director of the Admistrative Core. In addition, Dr. De Paris will be… $78,355
Scripps Research Institute Electron microscopy polyclonal epitope mapping (EMPEM) is a powerful technique for rapidly mapping the epitopes of serum antibodies and providing a visual… $230,000

Quick answers

Who received award P01AI189362?

P01AI189362 was awarded to Weill Medical College Of Cornell University by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on August 1, 2025.

How much is award P01AI189362 worth?

$8,874,264 has been obligated on P01AI189362.

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