Clinical Trial for New Ebola Vaccine Starts in Kambia District, Sierra Leone

‘EBOVAC-Salone’, a clinical trial to assess the safety and immunogenicity of a new vaccine against Ebola, has started with the vaccination of the first volunteers. The first volunteers to be vaccinated come from Kambia Town, and more volunteers from Kambia District will be enrolled in the study in stages over the course of the next few months.

This two-dose vaccine regimen – known as a ‘prime-boost’ vaccine regimen – being studied in EBOVAC-Salone is different to the vaccines currently being tested in other clinical trials in the region. The vaccines being studied are Ad26.ZEBOV and MVA-BN-Filo, and they were developed by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and Bavarian Nordic. These vaccines do not contain Ebola and it is not possible to become infected with Ebola by receiving them.

Volunteers in the study are first given the ‘prime’ dose to prepare the immune system to defend itself against the virus if it comes into contact with Ebola. Two months later volunteers receive the ‘boost’ dose in order to increase the immune response, with the goal of potentially strengthening and optimizing the duration of the immunity to the Ebola virus. This ‘prime-boost’ approach is already used in many routine immunizations around the world, including the polio immunization given in Sierra Leone.

The EBOVAC-Salone study, which is being run by a team of doctors and scientists led by Dr Bailah Leigh, Head of the Department of Community Health at the College of Medicine and Allied Health Sciences (COMAHS), brings together several leading global research institutions and non-government organizations including the Ministry of Health and Sanitation, COMAHS, Janssen Pharmaceutical Companies of Johnson & Johnson, London School of Hygiene & Tropical Medicine, Inserm, World Vision, Grameen Foundation and GOAL. These partners are working with support from the European Union’s Innovative Medicines Initiative Ebola+ programme.

“Ebola has devastated lives and communities across Sierra Leone and our neighbouring countries. Now that the epidemic is waning we must focus our efforts on preventing this happening ever again. Developing successful vaccines against this terrible disease is crucial if we are to fight Ebola in the future – and that is why we are doing the EBOVAC-Salone study, “ said Dr Bailah Leigh, Principal Investigator for EBOVAC-Salone who was speaking on the day of the first vaccination. “I am proud to be leading a team of Sierra Leonean doctors and nurses, working in partnership with our international colleagues, to study this new vaccine regimen against Ebola. I hope that our work on this EBOVAC-Salone study will help to save lives both here in Sierra Leone and beyond.”

The vaccine regimen, which is currently being tested in clinical studies in the United States, the United Kingdom, Kenya, Uganda and Tanzania, has already been given to several hundred people to date with no serious adverse events reported.

Studies are also planned for other European and African countries, but it is important that the vaccine is now studied in Sierra Leone so that the EBOVAC-Salone team can gather as much information as possible about how the vaccine works in people living in an area affected by Ebola.

Developing effective vaccines against Ebola is a global public health priority. To date, there is no licensed vaccine, treatment or cure for the Ebola virus, so new ways to stop people becoming infected with Ebola are urgently needed.   It is crucial to study a number of different vaccines in different populations and circumstances so that there is more than one tested and licensed vaccine available to prevent against future outbreaks of the Ebola virus.

Significant investment has been made to build new facilities in Kambia to conduct the study which will contribute substantially to the strengthening of the local health system. These include establishing the first Emergency Room at the Kambia District Hospital, and building a new vaccine storage facility on the hospital site. These efforts are complemented with the employment and training of doctors, nurses and other frontline healthcare workers who will gain valuable experience while contributing to the clinical study.

 ENDS

 Media Enquiries

For media enquiries please contact Tom Mooney, EBOVAC-Salone Communications Manager on +232 (0) 79 129 903 or thomas.mooney@lshtm.ac.uk

About the EBOVAC-Salone study

‘EBOVAC-Salone’, a clinical trial to assess the safety and immunogenicity of an Ebola vaccine regimen, will include adults, adolescents and children in Sierra Leone who volunteer to participate. Volunteers are planned to be enrolled in the study at different stages over the course of several months. In stage 1 of the study, approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity (immune response) of the prime-boost regimen. In stage 2, a larger group of approximately 400 individuals will be vaccinated to further evaluate the safety and immunogenicity of the vaccine regimen across different age groups. In this stage, adolescents and children will be included. Additional stages are being finalized in consultation with the Sierra Leonean authorities and international health agencies. Further details of the study are posted on clinicaltrials.gov.

 IMI Ebola+ projects and consortia members

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBOVAC1 (grant nr. 115854) and EBODAC (grant nr. 115847).

The IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding for the IMI Ebola+ programme comes in part from Horizon 2020, the European Union’s research and innovation programme, and in part in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.

  • Topic 1: Vaccine development; in Phase I, II, and III (EBOVAC 1 & 2)
    • Consortium members: Janssen, London School of Hygiene & Tropical Medicine, Oxford University, Institut National de la Santé et de la Recherche Médicale (INSERM), Le Centre Muraz
  • Topic 2: Manufacturing capability (EBOMAN)
    • Consortium members: Janssen, Bavarian Nordic A/S, Vibalogics
  • Topic 4: Deployment and compliance of vaccination regimens (EBODAC)
    • Consortium members: Janssen, London School of Hygiene & Tropical Medicine, Grameen Foundation, World Vision of Ireland

Further details of the projects are available on: http://www.ebovac.org.


About the Ebola Vaccine Regimen

Janssen’s investigational Ebola vaccine regimen was discovered in a collaborative research program with the National Institutes of Health (NIH). This program received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. The MVA-BN-Filo material used in phase 1 studies was produced under NIAID/Fisher BioServices contract #FBS-004-009 and NIH contract HHSN272200800044C. In January 2015, the Innovative Medicines Initiative (IMI) awarded a consortia of leading global research institutions and non-government organizations working in conjunction with the Janssen Pharmaceutical Companies grants totalling more than €100 million from the Ebola+ programme to support the development, manufacturing and deployment of the vaccine regimen.  In September, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, awarded $28.5 million to help accelerate the development of the vaccine regimen.

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2 Comments

  1. william Allieu says:

    I want to thanks all the donors for this wonderful trial,it really show how much you guys love this country.May God put his blessing upon this trial

  2. Johan van Dongn says:

    Professor Johan van Dongen
    Microsurgeon/Author
    The Netherlands.

    AFRICA

    Bio-warfare Laboratory of German and Japanese War Criminals Under Guidance of the USA.

    The Revealing Voices of Aids/HIV Theory Dissidents

    The horrific Aids pandemic tremendously has generated scientific controversies within and outside the scientific establishment. Only a minority of scientists, like Johan van Dongen, and other engaged people have access to inside information concerning (bio-warfare) Aids and Ebola research.

    As an experimental microsurgeon Johan van Dongen, in the early seventies, almost at the beginning of the multiple organ transplantation era, has carried out thousands of experimental organ transplantations. In order to deal with organ rejection he administered, radiation and sera for diminishing the immunity of the organ receiver. Besides that he also administered uncountable agents to recipients of organs in order to trigger, diminish or completely whipe out the immune capacity which can be compared with Aids.

    During his university and hospital appointments in the early seventies, and later undercover in the pharmaceutical industry, he discovered at that time that animals did’nt die because of rejection of the transplanted organ but because of multiple infections which can be compared with human Aids victims. So, Johan van Dongen noticed that Aids can be induced by radiation, aflatoxins, Immuran/prednisolone combination, anti lymfocyte sera and many other bio-warfare agents.

    Dormant HIV virus

    As head of the the Department of Experimental Microsurgery, and involved in all transplantation and immunological experiments, Johan also have been involved in many controversies. Especially the connection of his work and the polemic concerning the transmission of HIV in many ways he discovered not only in his experiments but also in the extensive scientific literature the role of an obligatory cofactor that transactivates the “Dormant” virus HIV in specific human cells. And this obligatory cofactor which transactivates the “Dormant” virus in specific human cells are deliberately introduced into mostly black-skinned African people, governed by massive environmental factors as you can read in our book: “Aids and Ebola the greatest crime in medical history against mankind,” in order to depopulate Africa.

    Therefore we will always like to enlighten readers about the real origin of Aids and the true nature of famous international researchers as Robert Gallo.

    And as far as Gallo is concerned, Ricardo Veronesi, professor of the Faculty of Medicine at the University of Sao Paulo, was personally informed about the true nature of Gallo’s research long before this controversy turned into a public scandal and as a consequence thousands of scientific Aids dissidents.

    It was no less then Francoise Barré-Sinoussi of the French Pasteur Institute who revealed the criminal intention of Gallo. And not only she became an Aids dissident but also the discover of the HIV virus Luc Montagnier disputed Gallo, the fake discoverer of the HIV virus.

    In their opinion the major bursts in the common scientific approach lies in its ignoring that the pathogenicity of the HIV indeed is governed by multiple deliberate environmental factors. And one of these determinant factors is the PCR test (Polymerase Chain Reaction Test).

    Polymerase Chain Reaction Test

    This test is a technology in molecular biology used to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Especially the diagnosis of hereditary diseases; the identification of genetic fingerprints, used in forensic sciences and paternity testing; and the detection and diagnosis of infectious diseases the PCR test can be used to investigate the connection of diseases to the specific black race. Moreover, PCR can be extensively modified to perform a wide array of genetic manipulations not only in humans but also from microorganisms which causes Aids and Ebola.

    Using and extrapolation of these kind of techniques we can conclude that almost all persons who have HIV in their bodies, were purposely infected with this virus which can lead to Aids. Biowarfare scientists are able to made black-skinned people artificially susceptible for HIV or Ebola by using controlable diseases as a cover-up.

    Most of the biowarfare research using viruses which causes Aids and Ebola was predominantly carried out in Germany and Japan until 1945 and since then mainly in the USA and France, using Nazi and Japanese (military) scientific war criminals.

    The Revealing Voices of Aids/HIV Theory Dissidents

    The official scientific origin of the diverse HIV-strains has been placed somewhere between 1938 and 1948 when scientist T.F. Smith et al published an article in the authoritative medical journal Nature about this period in 1988 named: “The phylogenetic history of immunodeficiency virus”.

    And he was’nt the only scientists who revealed the true nature of the HIV virus. Smith’s efforts to reveal the real origin of HIV was followed, to name a few, by Sharp et al with his article: “Understanding the origins of Aids viruses”, also in Nature, followed by Meyers et all with: “The phylogenetic analysis of the HIVs”. But the most important article is described in the top of the bill of medical journals the Lancet by scientist L.A. Evans et al who discovered the; “Simultaneous isolation of HIV-1 and HIV-2 from an Aids patient”.

    And all these mentioned scientist agreed that the distribution of the HIV virus was an intentional action. Their findings makes it very conceivable that this distribution was intentional because sometimes both the new viruses HIV-1 and HIV-2, respectively HTLV-IV, are existing in one and the same person according to Evans. And because his publication is checked by the editing and scientific boards of the Lancet the outcome of his investigation is true. And this counts also for thousands of publications in other medical journals as described in our book “Aids and Ebola the greatest crime in medical history against mankind”.

    German scientist Wolff Geisler

    According to the famous Aids/HIV theory dissident Wolff Geisler further evidents of the intentional distribution, out of the mentioned simultaneous infection of the same persons, it was described as a second Aids epidemic in the same black-skinned population by an inefficient transmission of the HIV virus. The appearance of this extreme rare retrovirus among the African Aids patients is so conspicious that some world famous scientists uttered a sentence about it. They alleged this to be; “Only another acquired opportunistic infection but rather an additional death sentence”. But? Is it?

    In Africa the probability of an early death of HIV patients is three times bigger then eslwere when HIV patients are simultaneously infected with HTLV-1 as described in the Lancet by Page et al in his scientific publication: HTLV-I/II seropositivity and death from Aids among HIV-I seropositive intravenous drug users (Lancet, 1990; 335: 1439-41), an even more extremely important publication for the Aids/HIV theory dissidents. Because especially HTLV-I, amongst many other HIV viruses, was only demonstrated in Uganda, Ghana, South Africa and Namibia. In HIV patients only in these countries appear simultaneously up till now. According to Wolff Geisler the concommitant existance of HTLV-I and HIV produces the observed rate of Aids patients in Uganda, Kenya and black-skinned people in Florida, USA and some Caibbean Islands, even though in general black-skinned persons are by nature more resistant against HIV-infection than pale-skinned persons (see below). This means the HIV viruses are geneticly engeneered as describe in our book.

    No less than Luc Montagnier et al, the discoverer of the HIV virus stated that this virus is made out of the Nazi eugenics and genetic engeneered experiments as well as the development of Aids causing viruses in horses. In a very talked about article he described in the authoritative Annals of Virology: “A new type of retrovirus from patients presenting with lymphadenopathy and acquired immune deficiency syndrome”: Structural and antigenetic relatedness with Equine Infecious Aenemia Virus EIAV (horse Aids), 1984; 135E: 119-31.

    Equine Infecious Aenemia Virus EIAV (HIV/Horse-Aids) made by Nazi Germany.

    If we compare these findings to our references in:“Aids the greatest crime in medical history against mankind” the book now available at Amazon, the HLA-A, B, C, DR3 and DR5 loci, is examined by the Nazi’s led by Otmar Verschuer.

    In 1956 he joined the American Eugenics Society and worked under auspices tiis of the Rockefeller-fund. He was also head of the Department of the Kaiser Wilhelm Institute in Germany.

    Furthermore we have to take into account that within people who have blood type HLA-DR3 Aids, it is much less common than in people who have the HLA-DR5 type. Under the Nazi’s research, it is important to note that precisely the HLA-DR5 type occurs mainly in Jews. The HLA-DR3 type contrast is most common in dark-colored Africans.

    These two evidences or references are enough to let you know vividly what took place. In general you can say that it is harder for blacks to get Aids than as it is for whites, but blacks have been made susceptible for a broad spectrum of brand new diseases caused by Germans, partly under the auspices of the South African Apartheid regime, and after the war under guidance of the U.S.A.

    Nowadays we now know that monkeys do not get Aids when infected with the human Aids virus. The same goes for tuberculosis until the moment that monkeys in a laboratory made receptive. Therefore black-skinned people are under no circumstances contaminated with Aids by monkeys with or without eating them. That is so to speak a criminal scientific ferrytale.

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