Ebola vaccine

Published

dm+d

Unassigned

New Medicines

Zabdeno + MvabeaPrevention of Ebola virus infection

Information

Zabdeno + Mvabea
Vaccine
Bavarian Nordic
Janssen Vaccines and Prevention BV

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Phase III Clinical Trials
Jun 21Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) recommends use of the two-dose Ebola vaccine regimen, Zabdeno and Mvabea. The recommendation from SAGE follows the Marketing Authorisation by the European Commission in July 2020 and WHO prequalification in April 2021 [16].
May 21Johnson & Johnson announced it would donate thousands of Ebola vaccine regimens to support a WHO program to support the use of the vaccine preventively for national and international first responders in neighboring areas or in countries where an outbreak might happen. [17]
Jul 20Marketing Authorisation under exceptional circumstances has been granted by the EU for Johnson & Johnson's Ebola vaccine. The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s AdVac® viral vector technology,5 and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN® technology, administered approximately eight weeks later [15].
May 20Recommended for EU approval by CHMP - the full indication is "Zabdeno, as part of the Zabdeno, Mvabea vaccine regimen, is indicated for active immunisation for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ≥ 1 year of age." The use of the vaccine regimen should be in accordance with official recommendations. [14]
Nov 19Filed in the EU under accelerated assessment. Janssen is seeking a license for the prevention of Ebola Virus Disease (EVD) specifically caused by Zaire ebolavirus species. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo) [13]
Oct 17In the US, the the Biomedical Advanced Research and Development Authority (BARDA) will provide $44.7 million for late stage development and purchase of Janssen Vaccines And Prevention BV´s two-dose Ebola vaccine under Project BioShield, which supports late-stage development toward licensing of Ebola vaccines and drugs, and stockpile for potential use in a public health emergency [10].
Aug 15Company pipeline indicates J&J is planning to submit regulatory filings for its monovalent ebola vaccine regimen in the US and EU in 2015 to 2019 [9].
Jan 15Johnson & Johnson launch a PI trial, which is being led by the Oxford Vaccine Group. J&J’s vaccine candidate is now the third Ebola vaccine currently being tested on humans, joining a group that includes the Merck-NewLink vaccine and the GSK vaccine [5].
Oct 14PI [1].
Feb 11Crucell was acquired by Johnson & Johnson [4].
Oct 08Crucell secured a NIAID/NIH award to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine [3].

Category

A multivalent filovirus vaccine against Ebola and Marburg in collaboration with the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases
Ebola virus is highly infectious and leads to a potentially fatal disease with fever, malaise, vomiting, mucosal and gastrointestinal bleeding, oedema, and hypotension. Mortality is 50-90% [2].
Prevention of Ebola virus infection
Parenteral

Trial or other data

Sep 21Positive immune response data announced from the double-blind, placebo controlled PIII Ebovac-Salone study (NCT02509494) in both adults and children aged 1 to 17 years for a 2-dose heterologous vaccine regimen in 1023 pts in in Sierra Leone. The study was divided into two stages; stage 1 involved 43 adults and stage 2 involved 400 adults and 576 children or adolescents. In this regimen, Ad26.ZEBOV was administered as a Dose 1 vaccination followed by the MVA-BN-Filo vaccine (Dose 2 56 days later) and a booster dose of A26.ZEBOV 2 years post Dose 1. The regimen was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98% of pts. There were no safety threats observed. Sierra Leone is recorded to have had the worst Ebola outbreak from 2014 to 2016. Johnson & Johnson is reportedly preparing to conduct a more extensive study on this vaccine in the future. [17]
Nov 16Crucell completes a PIII trial which assessed a range of dose levels of a heterologous prime-boost regimen of Ad26.ZEBOV and MVA BN®-Filo in 525 healthy volunteers in the US (NCT02543567). The trial was designed to demonstrate the non‐inferiority of a heterologous prime‐boost regimen using Ad26.ZEBOV as prime and MVA‐BN‐Filo as boost administered at different doses at a 56‐day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA‐BN‐Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (Glycoprotein) as measured by Enzyme‐linked Immunosorbent Assay (ELISA) [12].
Jul 16Crucell completed a phase III trial evaluating the immunogenicity, safety and tolerability of three different batches of Ad26.ZEBOV as prime and a single batch of MVA-BN-Filo as boost at a 56 day interval, in healthy volunteers (NCT02543268). The randomised, double-blind, parallel-assignment trial was initiated in September 2015 and enrolled 329 volunteers in the US who received intramuscular injections of the prime-boost regimen. The humoral immune responses were assessed by ELISA assay [9].
May 16A PIII trial to evaluate the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in volunteers previously exposed to these vaccines in phase I, II or III studies is currently recruiting (NCT02661464). The open-label, multicentre trial is estimated to recruit 922 volunteers and collection of the primary outcome should now complete May 22 [11].
Dec 15PII trial planned to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo as heterologous prime-boost regimens in healthy and in HIV-infected adults (NCT02598388).[8]
Jul 15A PII clinical study of an Ebola vaccine regimen being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson and Bavarian Nordic has started with healthy volunteers in England and France. The first arm of the trial will test the safety, tolerability and immunogenicity of the heterologous prime-boost regimen, which combines Bavarian Nordic’s MVA-BN Filo vaccine with Janssen´s Ad26.ZEBOV, in 612 healthy adult volunteers, who will be randomized into three cohorts, all receiving the Ad26.ZEBOV prime or placebo on day 1 and then the MVA-BN-Filo boost or placebo on days 29, 57 or 85. The study is part of the EBOVAC2 project, a collaborative program involving The University of Oxford, French Institute of Health and Medical Research (Inserm), London School of Hygiene & Tropical Medicine, La Centre Muraz, Inserm Transfert and Janssen [6,7].
Jan 15Crucell initiates a PI randomised, double-blind trial to investigate the safety and immunogenicity of prime-boost vaccine regimens using MVA-BN filovirus vaccine and Ad26 EBOV in healthy volunteers (CR106478; NCT02313077; VAC52150EBL1001). The trial is intended to enrol approximately 72 participants in the UK. The company has planned additional trials in the US and Africa [4].
Oct 14A second PI study is anticipated. This will use alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against the more commonly used adenovirus serotype 5 (Ad5) [3].
Sep 06Crucell’s Ebola vaccine entered PI clinical trials . Two groups of 16 volunteers were enrolled and vaccinated. The study showed safety and immunogenicity at the doses evaluated. It has also been shown to completely protect monkeys against the virus with a single dose of the vaccine [3].