Delving into the Latest Updates on AIDSVAX B/E vaccine(NIAID) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases+ [4]

Active Indication-

Inactive Indication

Acquired Immunodeficiency SyndromeEye InfectionsHIV Infections+ [3]

Originator Organization

National Institute of Allergy & Infectious Diseases

Active Organization-

Inactive Organization

Emergent BioSolutions, Inc.National Institute of Allergy & Infectious DiseasesEuroVacc Foundation

+ [1]

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Start Date01 Mar 2015

Sponsor / Collaborator

Emergent BioSolutions, Inc.

[+1]

100 Clinical Results associated with AIDSVAX B/E vaccine(NIAID)

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100 Translational Medicine associated with AIDSVAX B/E vaccine(NIAID)

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100 Patents (Medical) associated with AIDSVAX B/E vaccine(NIAID)

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80

Literatures (Medical) associated with AIDSVAX B/E vaccine(NIAID)

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 ; Sinangil, Faruk ; Pitisutthithum, Punnee ; Vasan, Sandhya ; Barrera, Michael D ; 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 ; Paquin-Proulx, Dominic ; Ake, Julie A ; 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.

01 May 2023·PLoS pathogens

Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response.

Article

Author: Rerks-Ngarm, Supachai ; Spreng, Rachel L ; O'Connell, Robert J ; Akapirat, Siriwat ; Vasan, Sandhya ; Dahora, Lindsay C ; Karasavvas, Nicos ; Excler, Jean-Louis ; Wills, Saintedym ; Sawant, Sheetal S ; Pittisuttithum, Punnee ; Robb, Merlin L ; Hope, Thomas J ; Michael, Nelson L ; Easterhoff, David ; Eller, Michael A ; Zhang, Lu ; Tay, Matthew Zirui ; Yates, Nicole L ; Williams, LaTonya D ; Tomaras, Georgia D ; Ferrari, Guido ; Goodman, Derrick ; Montefiori, David C ; Kim, Jerome H ; Tenney, DeAnna ; Stanfield-Oakley, Sherry ; Shen, Xiaoying ; Nitayaphan, Sorachai

The modestly efficacious HIV-1 vaccine regimen (RV144) conferred 31% vaccine efficacy at 3 years following the four-shot immunization series, coupled with rapid waning of putative immune correlates of decreased infection risk. New strategies to increase magnitude and durability of protective immunity are critically needed. The RV305 HIV-1 clinical trial evaluated the immunological impact of a follow-up boost of HIV-1-uninfected RV144 recipients after 6-8 years with RV144 immunogens (ALVAC-HIV alone, AIDSVAX B/E gp120 alone, or ALVAC-HIV + AIDSVAX B/E gp120). Previous reports demonstrated that this regimen elicited higher binding, antibody Fc function, and cellular responses than the primary RV144 regimen. However, the impact of the canarypox viral vector in driving antibody specificity, breadth, durability and function is unknown. We performed a follow-up analysis of humoral responses elicited in RV305 to determine the impact of the different booster immunogens on HIV-1 epitope specificity, antibody subclass, isotype, and Fc effector functions. Importantly, we observed that the ALVAC vaccine component directly contributed to improved breadth, function, and durability of vaccine-elicited antibody responses. Extended boosts in RV305 increased circulating antibody concentration and coverage of heterologous HIV-1 strains by V1V2-specific antibodies above estimated protective levels observed in RV144. Antibody Fc effector functions, specifically antibody-dependent cellular cytotoxicity and phagocytosis, were boosted to higher levels than was achieved in RV144. V1V2 Env IgG3, a correlate of lower HIV-1 risk, was not increased; plasma Env IgA (specifically IgA1), a correlate of increased HIV-1 risk, was elevated. The quality of the circulating polyclonal antibody response changed with each booster immunization. Remarkably, the ALVAC-HIV booster immunogen induced antibody responses post-second boost, indicating that the viral vector immunogen can be utilized to selectively enhance immune correlates of decreased HIV-1 risk. These results reveal a complex dynamic of HIV-1 immunity post-vaccination that may require careful balancing to achieve protective immunity in the vaccinated population. Trial registration: RV305 clinical trial (ClinicalTrials.gov number, NCT01435135). ClinicalTrials.gov Identifier: NCT00223080.

01 Jul 2021·VaccineQ3 · MEDICINE

AIDSVAX protein boost improves breadth and magnitude of vaccine-induced HIV-1 envelope-specific responses after a 7-year rest period

Q3 · MEDICINE

Article

Author: Lama, Javier R ; Cohen, Kristen ; Polakowski, Laura ; Kelley, Colleen F ; Seaton, Kelly E ; Buchbinder, Susan ; Yu, Chenchen ; Sobieszczyk, Magdalena ; Keefer, Michael ; Tomaras, Georgia D ; Robinson, Harriet L ; Elizaga, Marnie ; Maenza, Janine ; Paez, Carmen ; Miner, Maurine D ; McElrath, M Juliana ; Baden, Lindsey R ; Sinangil, Faruk ; De Rosa, Stephen C ; Lee, Carter ; Gulati, Vineeta ; Montefiori, David ; Huang, Yunda ; Casapia, Martin ; Goepfert, Paul

BACKGROUNDEliciting durable humoral immunity with sufficient breadth and magnitude is important for HIV-1 vaccine design. The HVTN 114 vaccine trial evaluated different boost regimens administered after a 7-year rest period in participants previously enrolled in HVTN 205, who received either three MVA/HIV62B (MMM) or two DNA and two MVA/HIV62B (DDMM) injections; both vaccines expressed multiple HIV-1 antigens in non-infectious virus-like-particles. The primary objective of HVTN 114 was to assess the impact of a heterologous gp120 protein AIDSVAX B/E boost on the magnitude, breadth and durability of vaccine-induced immune responses.METHODSWe enrolled 27 participants from HVTN 205 into five groups. Eight participants who previously received MMM were randomized and boosted with either MVA/HIV62B alone (T1; n = 4) or MVA/HIV62B and AIDSVAX B/E (T2; n = 4). Nineteen participants who received DDMM were randomized and boosted with MVA/HIV62B alone (T3; n = 6), MVA/HIV62B and AIDSVAX B/E (T4; n = 6), or AIDSVAX B/E alone (T5; n = 7). Boosts were at months 0 and 4. Participants were followed for safety and immunogenicity for 10 months and were pooled for analysis based on the regimen: MVA-only (T1 + T3), MVA + AIDSVAX (T2 + T4), and AIDSVAX-only (T5).RESULTSAll regimens were safe and well-tolerated. Prior to the boost vaccination, binding antibody and CD4+T-cell responses were observed 7 years after HVTN 205 vaccinations. Late boosting with AIDSVAX, with or without MVA, resulted in high binding antibody responses to gp120 and V1V2 epitopes, with increased magnitude and breadth compared to those observed in HVTN 205. Late boosting with MVA, with or without AIDSVAX, resulted in increased gp140 and gp41 antibody responses and higher CD4+T-cell responses to Env and Gag.CONCLUSIONSLate boosting with AIDSVAX, alone or in combination with MVA, can broaden binding antibody responses and increase T-cell responses even years following the original MVA/HIV62B with or without DNA-priming vaccine.

100 Deals associated with AIDSVAX B/E vaccine(NIAID)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	US	National Institute of Allergy & Infectious Diseases	19 Dec 2018
Eye Infections	Phase 2	US	Emergent BioSolutions, Inc.	31 Mar 2015
Respiratory Tract Infections	Phase 2	US	Emergent BioSolutions, Inc.	31 Mar 2015
Acquired Immunodeficiency Syndrome	Phase 2	UG	EuroVacc Foundation	01 Sep 2014
Schistosomiasis Mansoni	Phase 2	UG	EuroVacc Foundation	01 Sep 2014
HIV Infections	Phase 2	US	National Institute of Allergy & Infectious Diseases	31 Aug 2001

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03618056 (CTgov)	Phase 1	HIV Infections \| Systemic Lupus Erythematosus	1	AIDSVAX® B/E	ncxkngltlh(etlffgisdp) = kogmvfrshr hihskeqgyu (qnrtpqvjbj, lbokyinhns - clrldbcixc) View more	-	29 Dec 2021
NCT02852005 (CTgov)	Phase 1	HIV Infections	27	MVA (Group 1: Boost)	ymaciulebk(ehrzaynyly) = habrzthjcs eablorebzp (uraqwabard, lnfccjnwzr - hyzqxkhgot) View more	-	01 Apr 2021
NCT02852005 (CTgov)	Phase 1	HIV Infections	27	AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	ymaciulebk(ehrzaynyly) = hosjlpxhya eablorebzp (uraqwabard, jthialqyww - agqiuqyiim) View more	-	01 Apr 2021
AIDSVAX B/E efficacy trial (IAS2008)	Not Applicable	HIV Infections	196	AIDSVAX B/E vaccine	ylnmfrcvlj(xeaztdiwyq) = ovnxtfsowr lvgcgoolys (wnrrkihwef )	-	01 Jan 2008
AIDSVAX B/E (IAS2004)	Not Applicable	-	-	AIDSVAX® B/E HIV vaccine (AIDSVAX B/E)	(eaypzdzmlu) = hqkpgdiras liibpzgrbo (dmtpbpovnw, 7.3% - 9.4%) View more	-	01 Jan 2004
AIDSVAX B/E (IAS2004)	Not Applicable	-	-	Placebo	sxplesxcvp(relrskgosk) = kginyfpaxs siiirtzrxf (tdswynsgsy ) View more	-	01 Jan 2004
AIDSVAX B/B vaccine trial (IAS2004)	Not Applicable	HIV Infections	291	AIDSVAX® B/B vaccine	xwedsozdjb(rtzficyxct) = xaknudgiqh pgdeaikxvk (uweutwglth )	Negative	01 Jan 2004
IAS2002	Not Applicable	-	-	AIDSVAX B/B vaccine	ecdaxkepmq(ybgmmsqowf) = Social harms were reported by 3% of volunteers; of these, 97% were resolved and the most common were mild disturbances of personal relationships (63%) azzcyxbohy (mjudwmcfqf )	Positive	01 Jan 2002
IAS2002	Not Applicable	-	-	Placebo		Positive	01 Jan 2002
AIDSVAX®B/E vaccine trial (IAS2002)	Not Applicable	-	-	AIDSVAX®B/E vaccine	lwjaqszyvi(iybfldncig) = gffdmcsups gbgqxujgto (mjiocejsde ) View more	Positive	01 Jan 2002