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Zika virus vaccine - Sanofi Pasteur

Drug Profile

Zika virus vaccine - Sanofi Pasteur

Alternative Names: Zika virus purified inactivated vaccine - Sanofi Pasteur; ZIKV vaccine - Sanofi Pasteur; ZPIV - Sanofi Pasteur

Latest Information Update: 30 Nov 2018

At a glance

  • Originator Sanofi Pasteur
  • Developer National Institute of Allergy and Infectious Diseases; Sanofi Pasteur; Walter Reed Army Institute of Research
  • Class Viral vaccines; Zika virus vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Discontinued Zika virus infection

Most Recent Events

  • 30 Oct 2018 National Institute of Allergy and Infectious Diseases completes a phase-I clinical trials in Zika virus infection (Prevention) in USA (IM) (NCT02963909)
  • 04 Jun 2018 Beth Israel Deaconess Medical Center completes the Z001 phase I trial for Zika virus infection (Prevention) in USA (NCT02937233)
  • 05 Dec 2017 Adverse events data from three phase I trials in Zika virus infection released by Walter Reed Army Institute of Research

Development Overview

Introduction

Sanofi Pasteur was developing Zika virus purified inactivated vaccine for the prevention of Zika virus infection. Phase I development was underway in Puerto Rico and the US. However, Sanofi discontinued the development for Zika virus vaccine in the US and Puerto Rico following the Biomedical Advanced Research and Development Authority's decision to de-scope its contract with Sanofi to fund the manufacturing and clinical development of an inactivated Zika vaccine. Consequently, Sanofi does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the Zika vaccine candidate.

Company Agreements

In August 2017, Sanofi Pasteur reported that the company does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the development of Zika vaccine candidate.

In July 2016, Sanofi Pasteur signed a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. According to the terms of the agreement, Sanofi Pasteur will receive the Zika purified inactivated virus (ZPIV) vaccine technology from WRAIR and will create a clinical development and regulatory strategy. The agreement also includes Sanofi Pasteur’s production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product. Data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic samples generated during the performance of non-human primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV will be shared by WRAIR. The pre-clinical development of the candidate is being coordinated by WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center.A series of phase 1 ZPIV trials will be sponsored by NIAID. [1] [2]

In August 2017, Sanofi Pasteur was informed by the Biomedical Advanced Research and Development Authority (BARDA) that the BARDA had completed an assessment of all Zika-related projects they were funding and had decided to focus on limited set of goals and deliverables. As a result of their review, Sanofi Pasteur was notified about BARDA's decision to de-scope its contract with Sanofi to fund the manufacture and clinical development of an inactivated Zika vaccine. The BARDA will limit its funding to a case definition and surveillance study as well as any activities required required to advance Zika vaccine development to a point where development would be paused but could be restarted if the epidemic re-emerges [2] .

In September 2016, the Biomedical Advanced Research and Development Authority (BARDA) granted $US43.2 million to Sanofi Pasteur for studies in Zika virus infection. BARDA would fund the manufacturing of an inactivated Zika vaccine for phase II development. Under the terms of the contract, BARDA will have an option to continue support through phase III industrial and clinical development for the candidate, beyond the funding provided by BARDA for the two phase I/II clinical trials [3] .

Key Development Milestones

As of August 2017, Sanofi discontinued development for Zika virus vaccine in the US and Puerto Rico because the Biomedical Advanced Research and Development Authority decided to de-scope its contract with Sanofi to fund the manufacture and clinical development of an inactivated Zika vaccine. In addition, Sanofi does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the Zika vaccine candidate [2] .

Sanofi Pasteur and the the Walter Reed Army Institute of Research (WRAIR) had initiated phase I trials [see below] for Zika virus vaccine sponsored by National Institute of Allergy and Infectious Diseases (NIAID) [3] [1] .

Results from the three phase I trials NCT02963909, NCT02952833 and NCT02937233 [see below] released by Walter Reed Army Institute of Research in December 2017, showed that Zika purified inactivated virus vaccine induced robust immune response [4] .

In October 2018, NIAID completed a phase I trial designed to evaluate the safety, reactogenicity and immunogenicity of two doses of alum adjuvanted Zika virus purified inactivated vaccine (ZPIV) in healthy flavivirus-naïve and flavivirus-primed (YF-VAX® and IXIARO®) volunteers (16-0062; NCT02963909). The randomised, double-blinded, parallel study was initiated in November 2016 and recruited 75 volunteers in the US [5] .

In October 2016, NIAID initiated a phase I trial to evaluate the safety, reactogenicity and immunogenicity of alum adjuvanted ZPIV in a homologous prime-boost regimen to healthy flavivirus-naïve volunteers (16-0033; HHSN272200800003C; NCT02952833). The randomised, double-blinded, placebo-controlled, dose de-escalation, parallel study is designed to enrol 90 volunteers in the US [6] .

In June 2018, Beth Israel Deaconess Medical Center completed the Z001 phase I trial designed to evaluate the safety and immunogenicity of an accelerated vaccination schedule with a Zika virus purified inactivated vaccine plus alum adjuvant in healthy volunteers (2016P000268; NCT02937233). This placebo controlled, double-blind, randomised trial was initiated in October 2016 and enrolled 36 volunteers in the US [7] .

NIAID initiated a phase I trial to evaluate the safety, reactogenicity and immunogenicity of alum adjuvanted ZPIV administered to healthy male and non-pregnant female adult volunteers (16-0034; HHSN272201300021I; NCT03008122). The randomised, double-blinded, placebo-controlled, dose de-escalation, parallel study is designed to enrol 90 volunteers in Puerto Rico [8] .

Preclinical results demonstrated that an immune response was generated by single dose of Zika virus vaccine, which protected mice from subsequent Zika challenges, with Brazilian strain of virus [9] . In February 2016, Sanofi Pasteur initiated a research and development programme to develop a vaccine candidate for the prevention of Zika virus infection [10] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class Viral vaccines, Zika virus vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Zika virus infection - Prevention Discontinued (I) USA IM / Injection National Institute of Allergy and Infectious Diseases 08 Sep 2017
Zika virus infection - Prevention Discontinued (I) Puerto Rico IM / Injection National Institute of Allergy and Infectious Diseases, Walter Reed Army Institute of Research, Sanofi Pasteur 01 Sep 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Sanofi Pasteur Originator France
Sanofi Pasteur Owner France
Walter Reed Army Institute of Research Technology Provider USA
National Institute of Allergy and Infectious Diseases Funder USA
National Institute of Allergy and Infectious Diseases Collaborator USA
Walter Reed Army Institute of Research Collaborator USA
Beth Israel Deaconess Medical Center Collaborator USA
Biomedical Advanced Research and Development Authority Collaborator USA

Scientific Summary

Adverse Events

Results from the three phase I trials conducted in 67 healthy volunteers showed that Zika purified inactivated vaccine was safe and well tolerated [4] [5] [6] [7] .

Development History

Event Date Update Type Comment
30 Oct 2018 Trial Update National Institute of Allergy and Infectious Diseases completes a phase-I clinical trials in Zika virus infection (Prevention) in USA (IM) (NCT02963909) Updated 30 Nov 2018
04 Jun 2018 Trial Update Beth Israel Deaconess Medical Center completes the Z001 phase I trial for Zika virus infection (Prevention) in USA (NCT02937233) Updated 30 Nov 2018
05 Dec 2017 Scientific Update Adverse events data from three phase I trials in Zika virus infection released by Walter Reed Army Institute of Research [4] Updated 12 Dec 2017
08 Sep 2017 Phase Change - Discontinued(I) Discontinued - Phase-I for Zika virus infection (Prevention) in USA (IM) [2] Updated 08 Sep 2017
01 Sep 2017 Phase Change - Discontinued(I) Discontinued - Phase-I for Zika virus infection (Prevention) in Puerto Rico (IM) [2] Updated 08 Sep 2017
01 Nov 2016 Phase Change - I Phase-I clinical trials in Zika virus infection (Prevention) in USA (IM) (NCT02963909) Updated 10 Jan 2017
01 Oct 2016 Trial Update Beth Israel Deaconess Medical Center initiates enrolment in the Z001 phase I trial for Zika virus infection (Prevention) in USA (NCT02937233) Updated 20 Mar 2017
01 Oct 2016 Trial Update National Institute of Allergy and Infectious Diseases initiates a phase I trial for Zika virus infection (Prevention) in USA (IM) (NCT02952833) Updated 12 Jan 2017
26 Sep 2016 Phase Change - I Phase-I clinical trials in Zika virus infection (Prevention) in Puerto Rico (IM) (9203837; NCT03008122) Updated 29 Sep 2016
26 Sep 2016 Company Involvement Sanofi Pasteur receives US Biomedical Advanced Research and Development Authority grant for Zika virus vaccine development in Zika virus infection [3] Updated 28 Sep 2016
06 Jul 2016 Company Involvement Sanofi Pasteur establishes CRADA with Walter Reed Army Institute of Research for the development of Zika virus infection [1] Updated 13 Jul 2016
06 Jul 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection in France (Parenteral) [1] Updated 13 Jul 2016
06 Jul 2016 Trial Update Sanofi Pasteur plans a phase I trial for Zika virus infection [1] Updated 13 Jul 2016
02 Feb 2016 Phase Change Early research in Zika virus infection in France (Parenteral) Updated 05 Feb 2016

References

  1. SANOFI PASTEUR SIGNS RESEARCH AGREEMENT FOR ZIKA VACCINE.

    Media Release
  2. SANOFI STATEMENT ON ZIKA VACCINE LICENSE.

    Media Release
  3. BARDA Grants $ 43.2 million USD to Sanofi Pasteur for Zika.

    Media Release
  4. Army-developed Zika Vaccine Induces Strong Immune Response in Three Phase 1 Studies.

    Media Release
  5. A Phase 1, First-in-Human, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Healthy Flavivirus-Naïve and Flavivirus-Primed Subjects

    ctiprofile
  6. Phase 1, Double-blinded, Placebo-Controlled Study of the Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) Administered by the Intramuscular Route in Flavivirus Naïve Adult Subjects

    ctiprofile
  7. A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of an Accelerated Vaccination Schedule With a Zika Virus Purified Inactivated Vaccine Plus Alum Adjuvant in Healthy Adults

    ctiprofile
  8. Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate the Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) Administered by the Intramuscular Route in Adult Subjects Who Reside in a Flavivirus Endemic Area

    ctiprofile
  9. Army researchers team with Sanofi Pasteur to co-develop a Zika virus vaccine.

    Media Release
  10. SANOFI PASTEUR TO LEVERAGE ITS STRONG VACCINE LEGACY IN HUNT FOR ZIKA VACCINE.

    Media Release
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