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Completed

NCT Number: NCT02575456

A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine

A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.

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Key information

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Alie H Wurie

Freetown, Sierra Leone

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 50 years
  • Able to understand the content of informed consent and signed the informed consent
  • Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
  • Negative in HIV diagnostic blood test on day of enrollment
  • Axillary temperature ≤37.0°C on the day of enrollment
  • Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
  • General good health as established by medical history and physical examination.

Exclusion criteria

  • Infected by Ebola virus (inquiry)
  • Vaccination with other Ebola vaccine (inquiry)
  • HIV infection or other serious immunodeficiency disease (inquiry)
  • Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
  • Family history of brain or mental disease
  • Woman who is pregnant or breast-feeding
  • Any acute fever disease or infections in last 7 days
  • Major congenital defects or not well-controlled chronic illness
  • Asplenia or functional asplenia
  • Platelet disorder or other bleeding disorder
  • Faint at the sight of blood or needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine(s) in the last one month
  • Prior administration of inactivated vaccine(s) in the last 14 days
  • Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives

Treatment and study plan

Ebola Vaccine

Biological

Placebo

Biological

control

Primary outcomes

  1. Occurrence of solicited adverse reactions after vaccination

    Time frame: 7 days after vaccination

  2. ELISA antigen-specific assays for antibody to GP responses

    Time frame: 14 days after vaccination

  3. ELISA antigen-specific assays for antibody to GP responses

    Time frame: 28 days after vaccination

  4. ELISA antigen-specific assays for antibody to GP responses

    Time frame: 168 days after vaccination

Secondary outcomes

  1. Occurrence of unsolicited adverse reactions after vaccination

    Time frame: 28 days after vaccination

  2. Occurrence of serious adverse reaction during the whole follow-up period

    Time frame: 6 months

  3. Post-vaccination Rate of infected with HIV

    Time frame: 6 months

  4. Neutralizing antibody titers response to human Ad5

    Time frame: 14 days after vaccination

  5. Neutralizing antibody titers response to human Ad5

    Time frame: 28 days after vaccination

  6. Neutralizing antibody titers response to human Ad5

    Time frame: 168 days after vaccination

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Beijing Institute of Biotechnology
  • Tianjin Cansino Biotechnology Inc

Registry information

Official study title

A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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