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

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

MN rgp120/HIV-1 plus A244 rgp120/HIV-1

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases+ [4]

Active Indication-

Inactive Indication

Acquired Immunodeficiency SyndromeEye InfectionsHIV Infections+ [3]

Originator Organization

VaxGen, Inc.

Active Organization-

Inactive Organization

Emergent BioSolutions, Inc.EuroVacc Foundation

U S Army Medical Research & Development Command

+ [3]

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis.
The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment.
The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.
The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

Start Date15 Dec 2020

Sponsor / Collaborator

International AIDS Vaccine Initiative, Inc.

[+11]

NCT03618056

/ CompletedPhase 1IIT

A Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

Start Date19 Dec 2018

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT02852005

/ CompletedPhase 1IIT

A Phase 1 Clinical Trial to Evaluate the Immunogenicity of AIDSVAX B/E Bivalent gp120 Vaccine and MVA/HIV62B in Healthy, HIV-1-Uninfected Adult Participants Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.

Start Date01 Jan 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

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

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

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

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51

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

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 ; Ake, Julie A ; Rao, Mangala ; Paquin-Proulx, Dominic ; O'Connell, Robert J ; Sacdalan, Carlo ; Zemil, Michelle ; Shubin, Zhanna ; Kaewboon, Boot ; Wieczorek, Lindsay ; Anenia, Hanna ; 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 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 ; Yu, Chenchen ; Buchbinder, Susan ; Sobieszczyk, Magdalena ; Keefer, Michael ; Tomaras, Georgia D ; Elizaga, Marnie ; Robinson, Harriet L ; McElrath, M Juliana ; Maenza, Janine ; Paez, Carmen ; Miner, Maurine D ; Sinangil, Faruk ; Baden, Lindsey R ; 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.

25 Mar 2021·New England Journal of MedicineQ1 · MEDICINE

Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults

Q1 · MEDICINE

Article

Author: Sebe, Modulakgotla ; Kistnasami, Girisha ; Nchabeleng, Maphoshane ; Ncayiya, Cleon N. ; Modibedi, Bontle ; Diaz Granados, Carlos ; Jones, Megan ; Kalonji, Dishiki ; Corey, Lawrence ; Allen, Mary ; Prigmore, Brittany ; Mapetla, Katlego S. ; Laher, Fatima ; Malahleha, Mookho ; Grove, Doug ; Barnett, Susan W. ; Moodie, Zoe ; Naicker, Nivashnee ; Huang, Yunda ; Kassim, Sheetal ; Gaffoor, Zakir ; Ramirez, Shelly ; Adonis, Tania ; Janes, Holly ; Atujuna, Millicent ; Kotze, Philip ; Philip, Tricia ; Gilbert, Peter B. ; Bekker, Linda-Gail ; Dubula, Thozama ; Mathebula, Matsontso P. ; McElrath, M. Juliana ; Garrett, Nigel ; Brumskine, William ; Kee, Jia J. ; Meintjes, Graeme ; Koutsoukos, Marguerite ; Kobane, Gladys ; Wiesner, Lubbe ; Benkeser, David ; Phogat, Sanjay ; Hejazi, Nima S. ; Van Der Meeren, Olivier ; Hural, John ; Ward, Amy M. ; Bentley, Carter ; Innes, Craig ; Sikhosana, Mpho ; Makhoba, Philisiwe B. ; Kanesa-Thasan, Niranjan ; Selepe, Pearl ; Andrasik, Michele ; Naicker, Vimla ; Gray, Glenda E. ; Lazarus, Erica ; Kublin, James G. ; Puren, Adrian ; Grunenberg, Nicole ; Mda, Pamela ; Singh, Nishanta ; Takuva, Simbarashe

BACKGROUNDA safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox-protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1-2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa.METHODSIn this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months.RESULTSIn January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P = 0.84).CONCLUSIONSThe ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).

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

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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 3	United States	National Institute of Allergy & Infectious Diseases	19 Dec 2018
Eye Infections	Phase 3	United States	Emergent BioSolutions, Inc.	31 Mar 2015
Respiratory Tract Infections	Phase 3	United States	Emergent BioSolutions, Inc.	31 Mar 2015
Acquired Immunodeficiency Syndrome	Phase 3	Uganda	EuroVacc Foundation	01 Sep 2014
Schistosomiasis Mansoni	Phase 3	Uganda	EuroVacc Foundation	01 Sep 2014
HIV Infections	Phase 3	Thailand	VaxGen, Inc.	01 Mar 1999

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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	nvcvjiwmqe(uznbxmzier) = mqujliriox donatspagg (cwwuteiycp, wyubgxlpyl - mohfugrawz) View more	-	29 Dec 2021
NCT02852005 (CTgov)	Phase 1	HIV Infections	27	MVA (Group 1: Boost)	tiupzinlfk(kwqhjlxilc) = akgvdiokjq wfrsqtegyv (zdpbwwszoz, jqezzjmvme - njbuoljndr) View more	-	01 Apr 2021
				AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	tiupzinlfk(kwqhjlxilc) = ibkdyhklzz wfrsqtegyv (zdpbwwszoz, fpqzrswsap - vtvdlascuu) View more
NCT00223080 (RV144, CTgov)	Phase 3	HIV Infections	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	yawwzmhcna(fytvsswvaa) = lljxvgnhsp bhpmshbqlu (zfyjeaqdpd, gppwkplwdg - yrxwukpmhm) View more	-	19 Oct 2018
				ALVAC Placebo + AIDSVAX Placebo (Placebo)	yawwzmhcna(fytvsswvaa) = hfrwwnurmz bhpmshbqlu (zfyjeaqdpd, tzzgdwkjgt - zgofxzszfc) View more
AIDSVAX B/E efficacy trial (IAS2008)	Not Applicable	HIV Infections	196	AIDSVAX B/E vaccine	dvqvsqddii(fbrbcjarzr) = wvieaazqrr pjkvbyiczs (robeofizqm )	-	01 Jan 2008
AIDSVAX B/B vaccine trial (IAS2004)	Not Applicable	HIV Infections	291	AIDSVAX® B/B vaccine	qodaytvvzw(ielyglswdm) = zhjlhaffvs ixkahlmuoa (zohdvfaoqn )	Negative	01 Jan 2004
AIDSVAX B/E (IAS2004)	Not Applicable	-	-	AIDSVAX® B/E HIV vaccine (AIDSVAX B/E)	(buulhsumqr) = fsrjcubcwn ftiabwohwu (gehenigbsp, 7.3% - 9.4%) View more	-	01 Jan 2004
				Placebo	ewtbhefyqr(jrnhbwnjuk) = rtdoqkydtt fongnuhjbk (zqmckergrc ) View more
AIDSVAX®B/E vaccine trial (IAS2002)	Not Applicable	-	-	AIDSVAX®B/E vaccine	iylpekyfnh(dxnidtjftr) = ibfuipaxms jmdkisacqx (dwiurjuxhh ) View more	Positive	01 Jan 2002
IAS2002	Not Applicable	-	-	AIDSVAX B/B vaccine	cqitdnnlrx(nkpnkmiyhd) = Social harms were reported by 3% of volunteers; of these, 97% were resolved and the most common were mild disturbances of personal relationships (63%) fksbvgnmos (vszgkrqsdc )	Positive	01 Jan 2002
				Placebo