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

• ClinicalTrials.gov Identifier: NCT02533791
• Recruitment Status: Completed
• First Posted: August 27, 2015
• Last Update Posted: October 14, 2015
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborators: Beijing Institute of Biotechnology; Tianjin Cansino Biotechnology Inc
• Information provided by (Responsible Party): Jiangsu Province Centers for Disease Control and Prevention

Tracking Information

• First Submitted Date: August 21, 2015
• First Posted Date: August 27, 2015
• Last Update Posted Date: October 14, 2015
• Study Start Date: July 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2015)

• 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)
• 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
• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 26, 2015)

• 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)
• 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)
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Ebola Virus Disease

Intervention

• Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
  one dose, 4×10^10vp/1ml per dose
• Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
  two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
• Biological: placebo

Study Arms

• Experimental: low dose group
  4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
  Intervention: Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
• Experimental: high dose group
  1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
  Intervention: Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
• Placebo Comparator: placebo group
  placebo
  Intervention: Biological: placebo

• Publications *: Li JX, Hou LH, Meng FY, Wu SP, Hu YM, Liang Q, Chu K, Zhang Z, Xu JJ, Tang R, Wang WJ, Liu P, Hu JL, Luo L, Jiang R, Zhu FC, Chen W. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Glob Health. 2017 Mar;5(3):e324-e334. doi: 10.1016/S2214-109X(16)30367-9. Epub 2016 Dec 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 11, 2015): 110
• Original Estimated Enrollment (submitted: August 26, 2015): 120
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02533791
• Other Study ID Numbers: JSVCT020-2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
• Study Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Collaborators

• Beijing Institute of Biotechnology
• Tianjin Cansino Biotechnology Inc

Investigators

• Principal Investigator: Feng-Cai Zhu; Jiangsu Provincial Center for Disease Control and Prevention

• PRS Account: Jiangsu Province Centers for Disease Control and Prevention
• Verification Date: October 2015