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NCT Number: NCT02533791

A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃.

In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. The investigators intent to evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study. The investigators expect that the boosting immunization with a same vaccine for primary immunization is possible and could confer a longer-lived protection when needed.

The phase I trial has been unblind 28 days after the primary vaccination, but all the subjects are still kept blind as well as the laboratory staffs. Therefore, this booster vaccination trial will be conduct in single blind.

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Key information

Conditions

Ebola Virus Disease Filoviridae Infections Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral Infections Mononegavirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention

Taizhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who enrolled in the initial study, and completed the primary vaccination.
  • Able to understand the content of the additional informed consent and willing to sign the additional informed consent for the boosting study
  • Able and willing to complete a one-month follow-up.
  • HIV negative
  • Axillary temperature ≤37.0°C on the day of enrollment
  • General good health as established by medical history and physical examination.

Exclusion criteria

New occurrence of any of the following situation after the primary vaccination:

  • Subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV vaccine, such as mannitol
  • Woman who become pregnant after the primary vaccination or is positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment for the boosting study
  • Any acute fever disease or infections in last 7 days
  • Not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last 6 months
  • Asplenia or functional asplenia
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • 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 blood products in last 4 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine in last 1 month
  • Prior administration of inactivated vaccine in last 14 days
  • Current anti-tuberculosis prophylaxis or therapy
  • Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Treatment and study plan

4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)

Biological

one dose, 4×10^10vp/1ml per dose

1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)

Biological

two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time

Placebo

Biological

Primary outcomes

  1. Occurrence of adverse reactions after vaccination

    Time frame: within 7 days after the boosting

    Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  2. Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV)

    Time frame: 28 days after the boosting

    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA

  3. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV)

    Time frame: 28 days after the boosting

    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV)

Secondary outcomes

  1. Occurrence of adverse events after the vaccination

    Time frame: within 28 days after the boosting

    Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  2. Occurrence of serious adverse events after the vaccination

    Time frame: within 28 days after the boosting

    Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  3. Serum neutralizing antibody against the Ad5-vector

    Time frame: 28 days after the boosting

    Serum neutralizing antibody against the Ad5-vector 28 days after the boosting

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

Safety and Immunogenicity of a Booster Dose of the Recombinant Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults After Primary Immunization

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2015
Registry last updated
Oct 14, 2015

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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