Delving into the Latest Updates on HIV vaccine vCP1521(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

HIV Infections

Originator Organization

Sanofi

Active Organization-

Inactive Organization

National Institute of Allergy & Infectious Diseases

Sanofi Pasteur SA

U S Army Medical Research & Development Command

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Author: Dugast, Anne-Sophie ; Michael, Nelson L. ; Brown, Eric ; Alter, Galit ; Pitisuttithum, Punnee ; Choi, Ickwon ; Robinson, Hannah ; Liao, Larry ; Rolland, Morgane ; Kim, Jerome H. ; Ghebremichael, Musie ; Andrews, Charla ; Schoen, Matthew K. ; Bailey-Kellogg, Chris ; Rerks-Ngarm, Supachai ; Streeck, Hendrik ; Lane, Sophie ; Mahan, Alison E. ; Chung, Amy W. ; Kaewkungwal, Jaranit ; Francis, Donald ; Suscovich, Todd J. ; Nitayaphan, Sorachai ; de Souza, Mark S. ; Ackerman, Margaret E.

The human phase 2B RV144 ALVAC-HIV vCP1521/AIDSVAX B/E vaccine trial, held in Thailand, resulted in an estimated 31.2% efficacy against HIV infection. By contrast, vaccination with VAX003 (consisting of only AIDSVAX B/E) was not protective. Because protection within RV144 was observed in the absence of neutralizing antibody activity or cytotoxic T cell responses, we speculated that the specificity or qualitative differences in Fc-effector profiles of nonneutralizing antibodies may have accounted for the efficacy differences observed between the two trials. We show that the RV144 regimen elicited nonneutralizing antibodies with highly coordinated Fc-mediated effector responses through the selective induction of highly functional immunoglobulin G3 (IgG3). By contrast, VAX003 elicited monofunctional antibody responses influenced by IgG4 selection, which was promoted by repeated AIDSVAX B/E protein boosts. Moreover, only RV144 induced IgG1 and IgG3 antibodies targeting the crown of the HIV envelope V2 loop, albeit with limited coverage of breakthrough viral sequences. These data suggest that subclass selection differences associated with coordinated humoral functional responses targeting strain-specific protective V2 loop epitopes may underlie differences in vaccine efficacy observed between these two vaccine trials.

01 Mar 2014·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · MEDICINE

The First Pediatric HIV Vaccine Trial in Africa

Q3 · MEDICINE

Article

Author: Cao, Huyen ; Guay, Laura ; Kaleebu, Pontiano ; Musoke, Philippa ; Njai, Harr Freeya ; Fowler, Mary Glenn ; Baglyos, Lynn ; Emel, Lynda ; Richardson, Paul ; Ssewanyana, Isaac ; Jones, Norman ; Kintu, Kenneth ; Wang, Lei ; Ou, San-San ; Andrew, Philip ; Jackson, J Brooks

OBJECTIVEMaternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.DESIGNHIV Prevention Trials Network 027 was a randomized, double-blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1-infected mothers with CD4 counts of >500 cells per microliter, which were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag, and protease gene products.METHODSInfants were vaccinated at birth and 4, 8, and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using interferon-γ enzyme-linked immunosorbent spot, carboxyfluorescein diacetate succinimidyl ester proliferation, intracellular cytokine staining, and binding and neutralizing antibody assays. Fisher exact test was used to compare positive responses between the study arms.RESULTSLow levels of antigen-specific CD4 and CD8 T-cell responses (intracellular cytokine assay) were detected at 24 months (CD4-6/36 vaccine vs. 1/9 placebo; CD8-5/36 vaccine vs. 0/9 placebo) of age. There was a nonsignificant trend toward higher cellular immune response rates in vaccine recipients compared with placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.CONCLUSIONSHIV-1-exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.

01 May 2013·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · MEDICINE

Feasibility and Safety of ALVAC-HIV vCP1521 Vaccine in HIV-Exposed Infants in Uganda

Q3 · MEDICINE

Article

Author: San San Ou ; Jay Brooks Jackson ; Paul Richardson ; Kenneth Kintu ; Sanjay Gurunathan ; Laura Guay ; Sheryl Zwerski ; Lynda Emel ; Lei Wang ; Teopista Nakyanzi ; Philippa Musoke ; Brenda Asiimwe-Kateera ; Mary Glenn Fowler ; Philip Andrew ; Lynn Baglyos

BACKGROUNDThe development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported.METHODSHIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction.RESULTSFrom October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age].CONCLUSIONThe ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.

100 Deals associated with HIV vaccine vCP1521(Sanofi)

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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 3	Thailand	U S Army Medical Research & Development Command	01 Oct 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00223080 (RV144, CTgov)	Phase 3	HIV Infections	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	qohtwkfacp(saeigppuxk) = zqrfoszbwa qqfojbdsyf (vaucejxhjs, bfzchhlryh - jtgotplofc) View more	-	19 Oct 2018
NCT00223080 (RV144, CTgov)	Phase 3	HIV Infections	16,402	ALVAC Placebo + AIDSVAX Placebo (Placebo)	qohtwkfacp(saeigppuxk) = axjmeoabuu qqfojbdsyf (vaucejxhjs, reqvbuofem - rjkdbmfwjs) View more	-	19 Oct 2018
NCT00223080 (Pubmed \| PLoS One)	Phase 3	HIV Infections	16,402	ALVAC-HIV (vCP1521)canarypox ALVAC-HIV (vCP1521) (ALVAC-HIV (vCP1521))	igfamweimw(glrymcwhzg) = zcoymelufm pkhiyvivih (ijhvxirdmc ) View more	-	01 Jan 2011
NCT00223080 (Pubmed \| PLoS One)	Phase 3	HIV Infections	16,402	Placebo	igfamweimw(glrymcwhzg) = lccmyydipn pkhiyvivih (ijhvxirdmc ) View more	-	01 Jan 2011
IAS2002	Not Applicable	-	45	ALVAC-HIV (vCP1521)	(zssoohzwwo) = Seven serious adverse events were reported, none attributable to vaccine qtymjlaswi (nlpjljhjko ) View more	-	01 Jan 2002
IAS2002	Not Applicable	-	-	ALVAC-HIV (vCP1521)	kihvyouail(bwnngzotwh) = nqicvzzswf chhnsbpffn (xqlpprlytw ) View more	-	01 Jan 2002