Delving into the Latest Updates on A244 with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

Acquired Immunodeficiency SyndromeHIV Infections

Inactive Indication-

Originator Organization

U S Army Medical Research & Development Command

Active Organization

U S Army Medical Research & Development Command

Case Western Reserve University

University of Maryland Baltimore County

+ [2]

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimize vaccine adjuvant ALFQ dosing by assessing safety, reactogenicity, and immunogenicity. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Sixty human immunodeficiency virus (HIV) negative participants will be enrolled to one of three arms. Vaccinations via intramuscular (IM) injection will occur at months 0, 1, and 2. All participants will receive A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ.

Start Date29 Aug 2022

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+2]

NCT04658667 / RecruitingPhase 1IIT

Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920

The purpose of this study is to test whether delayed boosting (an extra administration of a vaccine) with the IHV01 (FLSC) protein and A244/AHFG with or without ALFQ will cause the body to make higher amounts of antibodies or different types of antibodies after the vaccination.

Start Date18 Jan 2022

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+3]

100 Clinical Results associated with A244

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100 Translational Medicine associated with A244

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100 Patents (Medical) associated with A244

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2

Literatures (Medical) associated with A244

08 May 2023·JCI insight

ALVAC-HIV and AIDSVAX B/E vaccination induce improved immune responses compared with AIDSVAX B/E vaccination alone.

Article

Author: Nitayaphan, Sorachai ; Robb, Merlin L ; Kim, Jerome H ; Phanuphak, Nittaya ; Pitisutthithum, Punnee ; Vasan, Sandhya ; Barrera, Michael D ; Sinangil, Faruk ; Costanzo, Margaret C ; Kim, Dohoon ; Gurunathan, Sanjay ; Eller, Michael A ; Thapa, Pallavi ; Kroon, Eugene ; Schuetz, Alexandra ; Chariyalertsak, Suwat ; Trinh, Hung V ; Akapirat, Siriwat ; Tipsuk, Somporn ; Nails, Barbara ; Rao, Mangala ; Ake, Julie A ; Paquin-Proulx, Dominic ; O'Connell, Robert J ; Sacdalan, Carlo ; Zemil, Michelle ; Shubin, Zhanna ; Kaewboon, Boot ; Anenia, Hanna ; Wieczorek, Lindsay ; Polonis, Victoria R ; Jongrakthaitae, Surat ; Boeckelman, Jacob

The RV144 phase III vaccine trial demonstrated that ALVAC-HIV and AIDSVAX B/E administration over 6 months resulted in 31% efficacy in preventing HIV acquisition, while administration of AIDSVAX B/E alone in both VAX003 and VAX004 studies failed to show efficacy. In this study, we aimed to understand the impact of ALVAC-HIV on the development of cellular, humoral, and functional immune responses compared to the administration of AIDSVAX B/E alone. ALVAC-HIV in combination with 3 doses of AIDSVAX B/E significantly increased CD4+ HIV-specific T cell responses, polyfunctionality, and proliferation compared with 3 doses of AIDSVAX B/E alone. Additionally, Env-specific plasmablasts and A244-specific memory B cells were identified with a significantly higher magnitude in the group that received ALVAC-HIV. Subsequently, data revealed increased magnitude of plasma IgG binding to and avidity for HIV Env in participants who received ALVAC-HIV compared with 3 doses of AIDSVAX B/E alone. Lastly, levels of the Fc-mediated effector functions antibody-dependent cellular cytotoxicity, NK cell activation, and trogocytosis were significantly increased in participants who received ALVAC-HIV compared with those receiving AIDSVAX B/E alone. Taken together, these results suggest that ALVAC-HIV plays an essential role in developing cellular and humoral immune responses to protein-boosted regimens relative to protein alone.

VaccinesQ3 · MEDICINE

Frequent and Durable Anti-HIV Envelope VIV2 IgG Responses Induced by HIV-1 DNA Priming and HIV-MVA Boosting in Healthy Tanzanian Volunteers

Q3 · MEDICINE

ArticleOA

Author: Sandström, Eric ; Bakari, Muhammad ; Rao, Mangala ; Nilsson, Charlotta ; Munseri, Patricia ; Joachim, Agricola ; Biberfeld, Gunnel ; Onkar, Sayali ; Aboud, Said ; Lyamuya, Eligius F ; Robb, Merlin L ; Mhalu, Fred S ; Msafiri, Frank ; Wahren, Britta ; Billings, Erik

We evaluated antibody responses to the human immunodeficiency virus (HIV) envelope variable regions 1 and 2 (V1V2) in 29 vaccinees who had received three HIV-1 DNA immunizations and two HIV-modified vaccinia virus Ankara (MVA) boosts in the phase I/II HIVIS03 vaccine trial. Twenty vaccinees received a third HIV-MVA boost after three years in the HIVIS06 trial. IgG and IgG antibody subclasses to gp70V1V2 proteins of HIV-1 A244, CN54, Consensus C, and Case A2 were analysed using an enzyme-linked immunosorbent assay (ELISA). Cyclic V2 peptides of A244, Consensus C, and MN were used in a surface plasmon resonance (SPR) assay. Four weeks after the second HIV-MVA, anti-V1V2 IgG antibodies to A244 were detected in 97% of HIVIS03 vaccinees, in 75% three years later, and in 95% after the third HIV-MVA. Anti-CN54 V1V2 IgG was detectable in 48% four weeks after the second HIV-MVA. The SPR data supported the findings. The IgG response was predominantly IgG1. Four weeks after the second HIV-MVA, 85% of vaccinees had IgG1 antibodies to V1V2 A244, which persisted in 25% for three-years. IgG3 and IgG4 antibodies to V1V2 A244 were rare. In conclusion, the HIV-DNA/MVA vaccine regimen induced durable V1V2 IgG antibody responses in a high proportion of vaccinees.

100 Deals associated with A244

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 1	US	U S Army Medical Research & Development Command	29 Aug 2022
HIV Infections	Phase 1	TH	University of Maryland Baltimore County	18 Jan 2022
HIV Infections	Phase 1	TH	Case Western Reserve University	18 Jan 2022
HIV Infections	Phase 1	TH	Duke University	18 Jan 2022
HIV Infections	Phase 1	TH	University of Maryland Baltimore	18 Jan 2022