As of June 2016, there have been a total of 28, 616 reported confirmed, probable, and suspected cases of Ebola Virus Disease (EVD) in Guinea, Liberia and Sierra Leone, with 11, 310 reported deaths (this total includes reported deaths among probable and suspected cases, although outcomes for many cases are unknown). For an update on the outbreak please visit the WHO Ebola virus disease outbreak.

WP 1: Project Management

The end of the first project reporting period was reached in April 2016 and the first project report was submitted on time to the European Commission, in June 2016. Report approval was granted by the European Commission during the summer 2016.

Four consortium meetings have so far been held in Brussels on December 2nd 2014 (project kick off), May 19th 2015, November 16th 2015 and September 27th 2016. All three meetings were one day meetings to which all project partners, including experts and JSC representatives attended.

These meetings gave project partners an excellent opportunity to discuss progress made on the project and plans for the future.

An Independent Advisory Board (IAB) for Ebolavac was set up during the third quarter of 2015. In this IAB, three candidates having expertise in different fields including ebola, infectious diseases, vaccines, ethics and regulatory matters were selected. These experts are Dr Vincent Ahonkhai, Dr Patricia Fast and Dr Sodiomon B Sirima. A first consultation with the members of the IAB took place during the third consortium meeting in November 2015. The members of the IAB were also invited to attend the fourth Ebolavac JSC in September 2016.

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WP 2: Phase 1/ 2 Lausanne Study

This trial was started on October 24th 2014 and was completed on June 22nd 2015. Between October 24th, 2014 and June 22nd, 2015 120 participants, 18 (15%) of whom were potentially deployed and 102 (85%) of whom were non-deployed, were randomly assigned to receive high dose vaccine, low dose vaccine, or placebo. All participants were followed up for 6 months post-treatment.

Safety, cellular and humoral immunity data were generated and analysed, and it was found that the two different doses of the ChAd3-EBO-Z candidate vaccine were both both equally safe, well tolerated and able to induce comparable immune responses. These findings led to a publication (De Santis et al., 2016. Lancet Infect Dis and, together with clinical data from other Phase 1 trials with the ChAd3-EBO-Z candidate but which are not part of the Ebolavac project, they enabled the selection of the dose of ChAd3-EBO-Z to be used for subsequent Phase 2 trials (1x1011 vp dose selected).

Following completion of the clinical trial, the clinical study report was submitted and approved by the competent authorities. Final results are expected to be posted on the study registry by the end of 2016.

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WP 3: Phase 2 RCT in African Countries

Initial safety and immunogenicity data from Phase 1 studies of the ChAd3-EBO-Z candidate vaccine has enabled selection of the most appropriate dose for testing in subsequent clinical trial studies. A large safety/immunogenicity healthy-volunteer Phase 2 study in adults has started at the end of July 2015. Since data from the first 100 adults showed acceptable safety, a Phase 2 safety and immunogenicity study in healthy children was also started in November 2015.

For the Phase 2 adult study, GSK was able to recruit a total of 3032 subjects, aged 18 years and above, by December 2015. Study completion is expected at the beginning of 2017. An interim analysis to assess safety, reactogenicity and immunogenicity data up to 30 days after vaccination is ongoing and the clinical report of this analysis is expected by the end of 2016. The results of this analysis will also be posted in the clinical trial registry.

The Phase 2 paediatric study terminated the recruitment of its 600 subjects, subjects aged from 1 to 17 years in May 2016. An interim analysis based on data accrued during the 30-day period after vaccination is currently ongoing. Study completion is expected second half of 2017.

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WP 4: Booster Study and Immunology

The first vaccinations in the EBL06 clinical trial in Dakar, Senegal were administered on July 2nd 2015. Enrolment of the expected 40 volunteers in the trial was completed on July 14th 2015 and vaccinations were completed on July 21st 2015. The trial was completed early 2016.

Volunteers were followed up for safety and immunogenicity evaluations leading to an interim clinical study report completed in September 2015.

The clinical study report is expected in the course of the second half of 2016 and development of a publication is ongoing.

A press release to communicate the start of the EBL06 trial in Senegal was issued on July, 15th 2015. To read this, click here.

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WP 6: Communication and Dissemination

The first EBOLAVAC paper was published in the Lancet Infectious Diseases journal in March 2016. In this publication titled “Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study” the authors assessed the safety and immunogenicity of a single injection of 2 different doses of the monovalent, recombinant, chimpanzee adenovirus type-3 vector-based Ebola Zaire vaccine (ChAd3-EBO-Z) by means of a clinical trial performed on healthy volunteers in Switzerland.

The trial demonstrated the two different doses of the ChAd3-EBO-Z candidate vaccine to be both equally immunogenic, safe and well tolerated.

To get access to the Lancet Infectious Diseases publication, follow the link here:http://www.sciencedirect.com/science/article/pii/S1473309915004867

Several press-releases were also issued in order to communicate about the project and clinical trials:

  • A first press release was published by CHUV on December 11th, 2014 to announce the completion of the vaccination in the Phase ½ Lausanne. Click here to access this.
  • A second press release was issued by GSK on December 16th, 2014 to communicate about the start of the Ebolavac project. To access this, click here.
  • Subsequently, UOXF released their first press release on July, 15th 2015 to communicate the start of the EBL06 trial in Senegal. To read this, click here.

The consortium has also had the opportunity to be represented at several congresses such as (list not exhaustive):

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WP 7: Advanced cell line process development

The process development and cGMP production of MVA-EBO Z on the AGE1.CR.pIX® cell line (ProBioGen) was completed in February 2015. The advantage of the new cell line is that up to a million doses can be produced annually.

GMP manufacture was performed at Emergent Biosolutions, Baltimore, US with funding support from Wellcome Trust and the EbolaVac project. About 40,000 doses have been manufactured with 10,000 doses presented in multi-dose vials.

Ethical and MHRA approval has been granted for the first use of this vaccine in humans in a clinical trial (EBL04) that commenced in the UK in June 2015. Subsequently, the vaccine was administered for the first time in African volunteers to boost a single dose of the ChAd3-EBO-Z during the EBL06 booster study (WP4), described above. Data from this trial will complement and extend current Phase I and II data available on the safety, reactogenicity and immunogenicity of the ChAd3-EBO-Z candidate vaccine.

The fact that the MVA-EBO Z was manufactured on a cell line, as opposed to chicken embryo fibroblasts (CEFs) could potentially allow larger scale manufacturing of MVA than is possible using CEFs. Considering that Ebola affects some of the world’s poorer countries and can spread rapidly, finding an affordable method to scale up the manufacturing of a candidate vaccine is key to delivering an effective response to an Ebola outbreak.

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