A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.

NCT02296983 | Unknown Phase 1 DMC

• 2 other identifiers: OXTREC 71-14SSC 2976
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities. There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective. There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted. The investigators are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations. The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine. The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine. The investigators will follow them up for a period of one year looking to their safety and immunogenicity endpoints.

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (1)

• The nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) with causal link to the study intervention

  To evaluate the safety and tolerability of two different doses of VSVΔG-ZEBOV vaccine

  Days 0-30

Secondary Outcomes (9)

• Incidence and severity of local and systemic reactogenicity signs and symptoms

  Day 0-28

• Incidence of unsolicited adverse events (AEs)

  Days 0-28

• Incidence of serious adverse events (SAEs)

  Days 0-365

• Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination

  Day 0-30

• Persistence of titres of ZEBOV-specific IgG antibodies

  0-180 days

Study Arms (2)

Low dose arm

EXPERIMENTAL

The low dose cohort will receive an intramuscular (deltoid) injection of 3x106 pfu of VSV-ZEBOV vaccine.

Biological: VSV-ZEBOV

Full dose arm

EXPERIMENTAL

The full dose cohort will receive an intramuscular (deltoid) injection1x107 pfu of VSV-ZEBOV vaccine.

Biological: VSV-ZEBOV

Interventions

VSV-ZEBOV BIOLOGICAL

VSV-ZEBOV

Also known as: BSPSC1001

Full dose arm; Low dose arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent prior to screening procedures (i.e. participants must be literate).
• Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55 (inclusive) at the time of screening
• Free of clinically significant health problems, as determined by pertinent medical history, clinical examination and blood tests at screening
• Available, able, and willing to participate for all study visits and procedures
• Negative pregnancy-test for female volunteers
• Females, of non-childbearing potential who are post-menopausal (i.e. ≥ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
• Females, of childbearing potential, who are willing to use effective methods of contraception for 14 days before vaccination and 30 days after vaccination.
• Males who are willing to use effective contraception following vaccination for a period of one week.
• Be willing to minimize blood and body fluid exposure of others for 5 days after vaccination

You may not qualify if:

• History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
• Known allergy to the components of the BPSC1001 vaccine product
• Unable or unwilling to stay in the study area for the period of the study and comply with study procedures.
• Ongoing participation in another clinical trial
• Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)
• Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test
• Any serologic evidence of hepatitis B SAg or HIV infection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes
• Have an active malignancy or history of metastatic or hematologic malignancy
• Suspected or known alcohol and/or illicit drug abuse within the past 5 years
• Moderate or severe illness and/or fever \>38°C within 2 weeks prior to vaccination
• Pregnant or lactating woman or a woman who intends to become pregnant within 30 days following vaccination.
• Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
• Administration of chronic (defined as more than 14 days) immunosuppressant's or other immune modifying drugs within 6 months of study entry
• Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study

Sponsors & Collaborators

• University of Oxford: lead
• World Health Organization: collaborator
• Wellcome Trust: collaborator
• Institute of Tropical Medicine, University of Tuebingen: collaborator
• Albert Schweitzer Hospital: collaborator
• Philipps University Marburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

KEMRI Wellcome Trust Research Programme

Kilifi, Coast, 80108, Kenya

Location

Related Publications (4)

• Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaitre B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Epub 2018 Apr 5.

  PMID: 29627147 DERIVED

• Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.

  PMID: 28647166 DERIVED

• Medaglini D, Harandi AM, Ottenhoff TH, Siegrist CA; VSV-Ebovac Consortium. Ebola vaccine R&D: Filling the knowledge gaps. Sci Transl Med. 2015 Dec 9;7(317):317ps24. doi: 10.1126/scitranslmed.aad3106.

  PMID: 26659569 DERIVED

• Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.

  PMID: 25830326 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Philip Bejon, MD, PhD

  KEMRI-Wellcome Trust Collaborative Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 21, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

KE (1)