Phase 1 N=61 Randomized Quadruple-blind Prevention

A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)

Ebola Disease · Immunisation

Bottom Line

View on ClinicalTrials.gov: NCT03583606 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Participants With Clinical Safety Laboratory Adverse Events — 2; 5; 4; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ChAd3-EBO-Z (Biological); MVA Multi-Filo Ebola Vaccine (Biological); Placebo (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Safety Laboratory Adverse Events	2; 5; 4; 2; 6; 2	—
PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs)	0; 0; 0	—
PRIMARY Number of Participants Reporting Solicited Local Reactogenicity	20; 20; 18; 13; 18; 14	—
PRIMARY Number of Participants Reporting Solicited Local Reactogenicity	20; 20; 18; 13; 18; 14	—
PRIMARY Number of Participants Reporting Solicited Local Reactogenicity	20; 20; 18; 13; 18; 14	—
PRIMARY Number of Participants Reporting Solicited Systemic Reactogenicity	20; 20; 15; 11; 12; 9	—
PRIMARY Number of Participants Reporting Solicited Systemic Reactogenicity	20; 20; 15; 11; 12; 9	—
PRIMARY Number of Participants Reporting Solicited Systemic Reactogenicity	20; 20; 15; 11; 12; 9	—
PRIMARY Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs)	0; 0; 0	—
PRIMARY Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)	4; 10; 4; 1; 1; 1	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells	19; 18; 17; 2; 2; 2	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin	19; 20; 18; 2; 0; 1	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count	21; 20; 19; 0; 0; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count	19; 17; 17; 0; 2; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT	20; 20; 19; 1; 0; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)	21; 19; 19; 0; 1; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium	21; 20; 19; 0; 0; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium	20; 20; 19; 0; 0; 0	—
PRIMARY Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN	1; 3; 1; 0; 0; 0	—
PRIMARY Number of Participants by Severity of Solicited Local Reactogenicity	17; 11; 11; 3; 7; 5	—
PRIMARY Number of Participants by Severity of Solicited Local Reactogenicity	17; 11; 11; 3; 7; 5	—
PRIMARY Number of Participants by Severity of Solicited Local Reactogenicity	17; 11; 11; 3; 7; 5	—
PRIMARY Number of Participants by Severity of Solicited Systemic Reactogenicity	6; 6; 3; 8; 7; 6	—
PRIMARY Number of Participants by Severity of Solicited Systemic Reactogenicity	6; 6; 3; 8; 7; 6	—
PRIMARY Number of Participants by Severity of Solicited Systemic Reactogenicity	6; 6; 3; 8; 7; 6	—
PRIMARY Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)	3; 7; 4; 1; 3; 0	—
SECONDARY Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population	1.1; 1.2; 1.3; 21.5; 21.0; 25.4	—
SECONDARY Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population	1.1; 1.2; 1.3; 25.1; 17.4; 23.1	—
SECONDARY Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population	29.5; 33.5; 32.3; 32.6; 40.2; 35.4	—
SECONDARY Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population	29.5; 33.5; 32.3; 32.6; 40.2; 35.4	—
SECONDARY Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population	1; 2; 1; 20; 17; 17	—
SECONDARY Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population	1; 2; 1; 17; 15; 16	—

Summary

This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.

Eligibility Criteria

Inclusion Criteria

Provide written informed consent before initiation of any study procedures.
Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
Males or non-pregnant females ages 18-45, inclusive.
Subject must have a body mass index (BMI) > / = 18.5 and 120 ms, PR interval = / > 210 ms, any second- or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Bazett's formula [QTcB] [> 450 ms]).
Significant repolarization (ST-segment or T-wave) abnormality.
Significant atrial or ventricular arrhythmia; frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row).
ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction
A diagnosis of Type I or II diabetes. (A history of isolated gestational diabetes is not an exclusion criterion).
Current employee or staff paid entirely or partially by the contract for this trial, or staff who are supervised by the PI or Sub-Investigators.
Any condition that would, in the opinion of the Site Investigator or appropriate sub-investigator, is a contraindication to study participation.
Including acute or chronic (persisting for at least 90 days) clinically significant medical disease or condition, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03583606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.