Delving into the Latest Updates on Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

HIV Infections

Originator Organization

Sanofi Pasteur

Active Organization-

Inactive Organization

Sanofi Pasteur

Sanofi

Drug Highest PhasePendingPhase 2/3

First Approval Date-

Regulation-

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Author: Kublin, James ; Edupuganti, Srilatha ; Rodriguez, Benigno ; Woodward Davis, Amanda S ; Seaton, Kelly E ; He, Zonglin ; Koutsoukos, Marguerite ; Maganga, Lucas ; Gurunathan, Sanjay ; Frank, Ian ; Tomaras, Georgia ; Laher Omar, Faatima ; Kalams, Spyros ; Laher, Fatima ; Stranix-Chibanda, Lynda ; Ferrari, Guido ; DiazGranados, Carlos A ; Baden, Lindsey R ; Van Der Meeren, Olivier ; Keefer, Michael ; McElrath, M Juliana ; Grunenberg, Nicole ; Scott, Hyman ; Corey, Lawrence ; Paez, Carmen ; deCamp, Allan C ; Dintwe, One ; Muyoyeta, Monde ; Polakowski, Laura ; Andersen-Nissen, Erica ; Chirenje, Zvavahera Mike ; Mayer, Kenneth

AbstractBackgroundHVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults.MethodsParticipants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses.ResultsWe enrolled 160 participants, 55% women, 18–40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups.ConclusionsThe 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses.Clinical Trials Registration . NCT03122223.

01 Aug 2024·Vaccine

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Article

Author: Malahleha, Mookho ; Chihana, Rachel ; Janes, Holly ; Grunenberg, Nicole ; Naicker, Nivashnee ; Naicker, Vimla ; Dadabhai, Sufia ; Huang, Yunda ; Gray, Glenda ; Roxby, Alison C ; Kublin, James G ; Innes, Craig ; Jin Kee, Jia ; Kumwenda, Johnstone ; Dubula, Thozama ; Laher, Fatima ; Allen, Mary ; Moodie, Zoe ; Kassim, Sheetal ; Bekker, Linda-Gail

BACKGROUNDReactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products.METHODSHVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18-35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables.RESULTSMore vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR_v = 2.50, OR_p = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002).CONCLUSIONVaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

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 ; Modibedi, Bontle ; Ncayiya, Cleon N. ; 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 ; Philip, Tricia ; Kotze, Philip ; Gilbert, Peter B. ; Bekker, Linda-Gail ; Dubula, Thozama ; Mathebula, Matsontso P. ; McElrath, M. Juliana ; Garrett, Nigel ; Brumskine, William ; Kee, Jia J. ; Koutsoukos, Marguerite ; Kobane, Gladys ; Meintjes, Graeme ; Wiesner, Lubbe ; Benkeser, David ; Phogat, Sanjay ; Hejazi, Nima S. ; Van Der Meeren, Olivier ; Hural, John ; Ward, Amy M. ; Bentley, Carter ; Innes, Craig ; Makhoba, Philisiwe B. ; Sikhosana, Mpho ; 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 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	ZA	Sanofi	26 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02968849 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2/3	HIV Infections	5,404	Bivalent Subtype C gp120-MF59+ALVAC-HIV	ppfvirnijk(wzychqyzly): HR = 1.02 (95% CI, 0.81 - 1.30), P-Value = 0.84	Negative	25 Mar 2021
				Placebo
NCT02404311 (HVTN 100, CTgov)	Phase 1/2	HIV Infections	252	ALVAC-HIV+Bivalent Subtype C gp120/MF59® (Part A, Group 1: Vaccine)	nqrlahbush(haqlwqerms) = oebecucqrx mqiwsffcyf (uapemrneir, xbykvcjenj - fyuyaebfxy) View more	-	19 Oct 2020
				ALVAC-HIV (vCP2438) Placebo+Bivalent gp120/MF59® Placebo (Part A, Group 2: Placebo)	nqrlahbush(haqlwqerms) = hcmajnbkau mqiwsffcyf (uapemrneir, lbnzsbrzdp - qzkibuhpcu) View more
NCT02915016 (HVTN108, CTgov)	Phase 1/2	HIV Infections	334	Placebo+DNA-HIV-PT123 vaccine+Bivalent Subtype C gp120/MF59 vaccine (Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59)	agczbuphcj(urhoqncffx) = adjqilzfdk rogvukbspc (bbzvahluck, abfirdicnl - sgzxhfcpai) View more	-	16 Sep 2020
				Placebo+Bivalent Subtype C gp120/AS01B vaccine+DNA-HIV-PT123 vaccine (Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B)	agczbuphcj(urhoqncffx) = mrgnejzqyk rogvukbspc (bbzvahluck, umqtnqdmxi - nqwvzszwkk) View more
NCT02404311 (HVTN 100, Pubmed) Manual	Phase 1/2	HIV Infections	252	bivalent subtype C gp120/MF59+ALVAC-HIV vector	zwvrijibyf(cthonyfwnf) = uextgnecdk ilvitkcwrp (quzsigaabj )	Positive	01 Jul 2018
				Placebo	zwvrijibyf(cthonyfwnf) = qntainscog ilvitkcwrp (quzsigaabj )