A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

NCT03333538 | Completed Phase 1

• 1 other identifier: 01-GamEvac-Lyo-2017
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease

Conditions

Healthy Volunteers

Keywords

Hemorrhagic Fever, Ebola; Ebola Virus Disease; Ebola Virus Vaccines; Hemorrhagic Fevers, Viral; GP protein, Ebola virus; Filoviridae Infections; RNA Virus Infections

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 90 days

• Number of Participants With Serious Adverse Events

  Determination of Number of Participants With Serious Adverse Events

  through the whole study, an average of 90 days

• Number of Participants with Solicited Local and Systemic Adverse Events

  Determination of Number of Participants with Solicited Local and Systemic Adverse Events

  through the whole study, an average of 90 days

• Antibody levels against the EBOV glycoprotein GP measured by an enzyme-linked immunosorbent assay (ELISA)

  Determination of antibody levels against the EBOV glycoprotein GP measured by an ELISA vs. baseline values and placebo

  at days 0, 21, 42, 28 and 90

Secondary Outcomes (4)

• Assessment of antigen-specific cell-mediated immune response

  at days 0 and 28

• Neutralizing antibody levels measured by a virus-neutralization assay

  at days 0 and 28

• Change of the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) after administration of the product

  through the whole study, an average of 90 days

• Change of the clinical laboratory test results after administration of the product

  through the whole study, an average of 90 days

Study Arms (4)

Stage 1 (component A)

EXPERIMENTAL

a single administration of component A (VSV) of vaccine

Biological: GamEvac-Lyo (component A)

Stage 1 (component B)

EXPERIMENTAL

a single administration of component B (Ad5) of vaccine

Biological: GamEvac-Lyo (component B)

Stage 2 (Primary Group)

EXPERIMENTAL

150 people who will receive the vaccine in the therapeutic scheme: the sequential introduction of components A and B with an interval of 21 days

Biological: GamEvac-Lyo

Stage 2 (Controll Group)

PLACEBO COMPARATOR

50 people who will receive placebo in the therapeutic scheme: the sequential introduction of components A (placebo) and B (placebo) with an interval of 21 days

Other: Placebo

Interventions

GamEvac-Lyo (component A) BIOLOGICAL

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A

Stage 1 (component A)

Placebo OTHER

Placebo vaccination

Stage 2 (Controll Group)

GamEvac-Lyo (component B) BIOLOGICAL

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B

Stage 1 (component B)

GamEvac-Lyo BIOLOGICAL

Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days

Stage 2 (Primary Group)

Eligibility Criteria

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

You may qualify if:

• males and females within the age range from 18 to 55 years;
• written informed consent;
• subject body mass index (BMI): 18.5 ≤ BMI ≤ 30
• subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device);
• absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
• absence of allergic diseases relapses
• absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination
• no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products
• in medical history and based on the screening results, subject has no diseases of the gastrointestinal system, liver, kidneys, cardiovascular system, CNS, locomotion system, urogenital and endocrine systems that could affect the assessment of the study results
• subject has a negative result of the blood or urine pregnancy test (for females of childbearing age)
• subject has negative tests for HIV, hepatitis B and С, syphilis
• subject has a negative result of the urine test for residual narcotic drugs
• subject has no hematopoietic malignancies
• subject has no malignant neoplasms
• indicators of complete blood count test at a screening visit are not heigher/lower from 1,1\*ULN/LLN (upper limit of normal/lower limit of normal)

You may not qualify if:

• volunteer involvement in another study over the last 90 days
• any immunization with vaccine over the last 30 days
• presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus)
• subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 90 beats per minute
• any clinically significant laboratory abnormalities
• subject has received treatment with steroids for the last 10 days
• subject has received immunoglobulins or other blood products over the last 3 months
• patient unwillingness to participate in the study
• blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study
• subject has a history of the consumption of more than 5 units (0.25 l of pure alcohol) a week or drug abuse
• subject smokes more than 10 cigarettes a day
• positive results of urine test for narcotic drug residues
• positive result of breath alcohol test (in the expired air sample)
• subject has no ability to understand or follow the Protocol instructions
• patient unwillingness to follow the procedures

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Research Institute of Influenza, Sankt-Peterburg, Russian Federation: collaborator

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral; Filoviridae Infections; RNA Virus Infections

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Mononegavirales Infections

Study Officials

• Tatiana Zubkova, MD, PhD

  Research Institute of Influenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical trial is designed as a double blind randomized placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 7, 2017
• Study Start: November 3, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: November 14, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)