The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.

Start Date01 Jul 2007

Sponsor / Collaborator

National Agency for Research on AIDS and Viral Hepatitis

[+1]

ISRCTN68071690 / CompletedNot ApplicableIIT

A phase I study of NYVAC C in healthy volunteers at low risk of human immunodeficiency virus (HIV) infection

Start Date04 Aug 2003

Sponsor / Collaborator

Imperial College London

100 Clinical Results associated with NYVAC-C

100 Translational Medicine associated with NYVAC-C

100 Patents (Medical) associated with NYVAC-C

101

Literatures (Medical) associated with NYVAC-C

01 Nov 2019·The Lancet HIVQ1 · MEDICINE

Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial

Q1 · MEDICINE

Article

Author: Karuna, Shelly ; Gilbert, Peter B ; Kublin, James G ; Corey, Lawrence ; Lee, Carter ; Ouedraogo, G Laissa ; Tomaras, Georgia D ; Esteban, Mariano ; Wagner, Ralf ; Ferrari, Guido ; Ding, Song ; Frahm, Nicole ; Allen, Mary ; Pantaleo, Giuseppe ; Grant, Shannon ; Janes, Holly ; Montefiori, David C ; McElrath, M Juliana ; Rettby, Nils ; Robb, Merlin L ; Bart, Pierre-Alexandre

BACKGROUNDUp to now, immunisation regimens that have been assessed for development of HIV vaccines have included purified envelope (Env) protein among the boosting components of the regimen. We postulated that co-administration of Env protein with either a DNA or NYVAC vector during priming would result in early generation of antibody responses to the Env V1/V2 region, which are important markers for effective protection against infection. We aimed to assess the safety and immunogenicity of a multivalent HIV vaccine including either DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost.METHODSWe did a single-centre, double-blind, placebo-controlled phase 1b trial at the Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland). We included healthy volunteers aged 18-50 years who were at low risk of HIV infection. We randomly allocated participants using computer-generated random numbers to one of four vaccination schedules or placebo (4:1), and within these schedules participants were allocated either active treatment (T1, T2, T3, and T4) or placebo (C1, C2, C3, and C4). T1 consisted of two doses of NYVAC vector followed by two doses of NYVAC vector and gp120 Env protein; T2 comprised four doses of NYVAC vector and gp120 Env protein; T3 was two doses of DNA vector followed by two doses of NYVAC vector and gp120 Env protein; and T4 was two doses of DNA vector and gp120 Env protein followed by two doses of NYVAC vector and gp120 Env protein. Placebo injections were matched to the corresponding active treatment group. Doses were administered by injection at months 0, 1, 3, and 6. Primary outcomes were safety and immunogenicity of the vaccine schedules. Immune response measures included cross-clade and epitope-specific binding antibodies, neutralising antibodies, and antibody-dependent cell-mediated cytotoxicity measured 2 weeks after the month 1, 3, and 6 vaccinations. This trial is registered with ClinicalTrials.gov, NCT01799954.FINDINGSBetween Aug 23, 2012, and April 18, 2013, 148 healthy adult volunteers were screened for the trial, of whom 96 participants were enrolled. 20 individuals were allocated to each active treatment group (groups T1-4; n=80) and four were assigned to each placebo group (groups C1-4; n=16). Vaccines containing the NYVAC vector (groups T1 and T2) were associated with more frequent severe reactogenicity and more adverse events than were vaccines containing the DNA vector (groups T3 and T4). The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2). Two participants, one in the placebo group and one in the DNA-primed T3 group, had serious adverse events that were judged unrelated to study product. One participant in the T3 group died from cranial trauma after a motor vehicle accident. Across the active treatment groups, IgG responses 2 weeks after the 6-month dose of vaccine were 74-95%. Early administration of gp120 Env protein (groups T2 and T4) was associated with a substantially earlier and higher area under the curve for gp120 Env binding, production of anti-V1/V2 and neutralising antibodies, and better antibody-response coverage over a period of 18 months, compared with vaccination regimens that delayed administration of gp120 Env protein until the 3-month vaccination (groups T1 and T3).INTERPRETATIONCo-administration of gp120 Env protein components with DNA or NYVAC vectors during priming led to early and potent induction of Env V1/V2 IgG binding antibody responses. This immunisation approach should be considered for induction of preventive antibodies in future HIV vaccine efficacy trials.FUNDINGNational Institutes of Health, National Institute of Allergy and Infectious Diseases, and the Bill & Melinda Gates Foundation.

01 Feb 2019·Journal of VirologyQ2 · MEDICINE

Replication-Competent NYVAC-KC Yields Improved Immunogenicity to HIV-1 Antigens in Rhesus Macaques Compared to Nonreplicating NYVAC

Q2 · MEDICINE

Article

Author: Jacobs, Bertram L. ; Montefiori, David C. ; Forthal, Donald N. ; Ding, Song ; Roederer, Mario ; Gottardo, Raphael ; Barnett, Susan ; Foulds, Kathryn E. ; Ferrari, Guido ; Wagner, Ralf ; Phogat, Sanjay ; Asbach, Benedikt ; Tartaglia, James ; Esteban, Mariano ; Galmin, Lindsey ; Self, Steve ; Parks, Robert ; Weiss, Deborah ; Heeney, Jonathan L. ; Cristillo, Anthony D. ; Stanfield-Oakley, Sherry ; Pantaleo, Giuseppe ; Perdiguero, Beatriz ; Kibler, Karen V. ; García-Arriaza, Juan ; Yates, Nicole L. ; Tomaras, Georgia D. ; Seaman, Michael S.

Though the RV144 phase III clinical trial showed promise that an effective vaccine against HIV-1 is possible, a successful vaccine will require improvement over the vaccine candidate (ALVAC) used in the RV144 study. With that goal in mind, we have tested in nonhuman primates an attenuated but replication-competent vector, NYVAC-KC, in direct comparison to its parental vector, NYVAC, which is replication restricted in human cells, similar to the ALVAC vector used in RV144. We have utilized a prime-boost regimen for administration of the vaccine candidate that is similar to the one used in the RV144 study. The results of this study indicate that a replication-competent poxvirus vector may improve upon the effectiveness of the RV144 clinical trial vaccine candidate.

15 Apr 2018·Journal of VirologyQ2 · MEDICINE

Immunogenicity of NYVAC Prime-Protein Boost Human Immunodeficiency Virus Type 1 Envelope Vaccination and Simian-Human Immunodeficiency Virus Challenge of Nonhuman Primates

Q2 · MEDICINE

Article

Author: Tartaglia, James ; Gomez, Carmen E. ; Eaton, Amanda ; Kibler, Karen ; Esteban, Mariano ; Goodman, Derrick ; Sutherland, Laura L. ; Montefiori, David C. ; Ferrari, Guido ; Pantaleo, Giuseppe ; Vandergrift, Nathan ; Parks, Robert ; Yates, Nicole L. ; Liao, Hua-Xin ; Scearce, Richard M. ; Bradley, Todd ; Korber, Bette ; Saunders, Kevin O. ; Haynes, Barton F. ; Perdiguero, Beatriz ; Jacobs, Bertram ; Tomaras, Georgia D. ; Santra, Sampa ; Stanfield-Oakley, Sherry A. ; Balachandran, Harikrishnan ; Phogat, Sanjay

ABSTRACTA preventive human immunodeficiency virus type 1 (HIV-1) vaccine is an essential part of the strategy to eradicate AIDS. A critical question is whether antibodies that do not neutralize primary isolate (tier 2) HIV-1 strains can protect from infection. In this study, we investigated the ability of an attenuated poxvirus vector (NYVAC) prime-envelope gp120 boost to elicit potentially protective antibody responses in a rhesus macaque model of mucosal simian-human immunodeficiency virus (SHIV) infection. NYVAC vector delivery of a group M consensus envelope, trivalent mosaic envelopes, or a natural clade B isolate B.1059 envelope elicited antibodies that mediated neutralization of tier 1 viruses, cellular cytotoxicity, and phagocytosis. None of the macaques made neutralizing antibodies against the tier 2 SHIV SF162P3 used for mucosal challenge. Significant protection from infection was not observed for the three groups of vaccinated macaques compared to unvaccinated macaques, although binding antibody to HIV-1 Env correlated with decreased viremia after challenge. Thus, NYVAC Env prime-gp120 boost vaccination elicited polyfunctional, nonneutralizing antibody responses with minimal protective activity against tier 2 SHIV mucosal challenge.IMPORTANCE The antibody responses that confer protection against HIV-1 infection remain unknown. Polyfunctional antibody responses correlated with time to infection in previous macaque studies. Determining the ability of vaccines to induce these types of responses is critical for understanding how to improve upon the one efficacious human HIV-1 vaccine trial completed thus far. We characterized the antibody responses induced by a NYVAC-protein vaccine and determined the protective capacity of polyfunctional antibody responses in an R5, tier 2 mucosal SHIV infection model.

100 Deals associated with NYVAC-C

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	GB	EuroVacc Foundation	-
HIV Infections	Phase 2	CH	EuroVacc Foundation	-
HIV Infections	Phase 2	-	Sanofi	-
HIV Infections	Phase 2	FR	EuroVacc Foundation	-
HIV Infections	Phase 2	-	GENEART AG	-
HIV Infections	Phase 2	-	University of Regensburg	-

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