Trial Outcomes & Findings for A Study of a New Vaccine Against Two Types of Ebola (NCT NCT05079750)

Last Updated: 2025-04-04

Results Overview

Occurrence of solicited local and systemic reactogenicity signs and symptoms. Data shown are number (and percentage) of participants reporting each event. The maximum severity of any local and any systemic solicited symptoms reported by individual participants is also shown.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

7 days following vaccination

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Low Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose n=14 participants vaccinated with either a single dose (n=7) or two doses twelve weeks apart (n=7) of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Overall Study STARTED	6	6	14
Overall Study COMPLETED	6	6	13
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Low Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose n=14 participants vaccinated with either a single dose (n=7) or two doses twelve weeks apart (n=7) of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

A Study of a New Vaccine Against Two Types of Ebola

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Single Dose n=7 Participants n=7 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with two doses twelve weeks apart of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Total n=26 Participants Total of all reporting groups
Age, Customized	24 years n=5 Participants	26 years n=7 Participants	20 years n=5 Participants	30 years n=4 Participants	28 years n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Black Carribean and Mixed White or	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian or Asian British	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Other Asian Background	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	26 Participants n=21 Participants

PRIMARY outcome

Timeframe: 7 days following vaccination

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any local symptom · Did not report this event	4 Participants	3 Participants	2 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Pain · Moderate	1 Participants	0 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Redness · Did not report this event	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Itch · Moderate	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Warmth · Mild	2 Participants	2 Participants	1 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Warmth · Did not report this event	12 Participants	4 Participants	4 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fever · Mild	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fever · Moderate	0 Participants	0 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fever · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Myalgia · Moderate	4 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Myalgia · Did not report this event	4 Participants	6 Participants	4 Participants	5 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Pain · Mild	9 Participants	3 Participants	4 Participants	4 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any local symptom · Mild	9 Participants	3 Participants	3 Participants	4 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any local symptom · Moderate	1 Participants	0 Participants	1 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any local symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Pain · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Pain · Did not report this event	4 Participants	3 Participants	2 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Redness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Redness · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Itch · Mild	0 Participants	1 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Itch · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Itch · Did not report this event	14 Participants	5 Participants	5 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Warmth · Moderate	0 Participants	0 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Warmth · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any systemic symptom · Mild	2 Participants	3 Participants	3 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any systemic symptom · Moderate	10 Participants	3 Participants	2 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any systemic symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Any systemic symptom · Did not report this event	2 Participants	0 Participants	1 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fever · Did not report this event	14 Participants	6 Participants	6 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Myalgia · Mild	6 Participants	0 Participants	2 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Nausea · Mild	4 Participants	3 Participants	1 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Nausea · Moderate	1 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Nausea · Did not report this event	9 Participants	3 Participants	5 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Malaise · Mild	4 Participants	1 Participants	4 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Malaise · Moderate	6 Participants	0 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Malaise · Did not report this event	4 Participants	5 Participants	2 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Arthralgia · Mild	1 Participants	1 Participants	2 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Arthralgia · Moderate	3 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Arthralgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Arthralgia · Did not report this event	10 Participants	5 Participants	4 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fatigue · Mild	6 Participants	2 Participants	3 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fatigue · Moderate	5 Participants	2 Participants	1 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fatigue · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Fatigue · Did not report this event	3 Participants	2 Participants	2 Participants	4 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Feverishness · Mild	6 Participants	2 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Feverishness · Moderate	4 Participants	0 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Feverishness · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Feverishness · Did not report this event	4 Participants	4 Participants	5 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Headache · Mild	6 Participants	3 Participants	3 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Headache · Moderate	4 Participants	1 Participants	1 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms Headache · Did not report this event	4 Participants	2 Participants	2 Participants	3 Participants

PRIMARY outcome

Timeframe: 28 days following vaccination

Occurrence of unsolicited adverse events (AEs)

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Infections and infestations (vaccine-unrelated)	0 Participants	0 Participants	1 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Cardiac disorders (vaccine-related)	0 Participants	0 Participants	2 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Gastrointestinal disorders (vaccine-related)	1 Participants	1 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms General disorders and administration site reactions (vaccine-related)	2 Participants	0 Participants	2 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Musculoskeletal and connective tissue disorders (vaccine-related)	3 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Infections and infestations (vaccine-related)	0 Participants	0 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Nervous system disorders (vaccine-related)	3 Participants	0 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Reproductive system and breast disorders (vaccine-related)	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Respiratory, thoracic and mediastinal disorders (vaccine-related)	1 Participants	2 Participants	2 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Cardiac disorders (vaccine-unrelated)	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Gastrointestinal disorders (vaccine-unrelated)	1 Participants	3 Participants	0 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms General disorders and administration site reactions (vaccine-unrelated)	3 Participants	3 Participants	0 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Musculoskeletal and connective tissue disorders (vaccine-unrelated)	1 Participants	1 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Nervous system disorders (vaccine-unrelated)	3 Participants	1 Participants	2 Participants	3 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Reproductive system and breast disorders (vaccine-unrelated)	0 Participants	1 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms Respiratory, thoracic and mediastinal disorders (vaccine-unrelated)	5 Participants	1 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Duration of the study (6 months)

Occurrence of serious adverse events (SAEs) and adverse interests of special interest (AESIs)

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days following vaccination

Abnormal results were graded according to a pre-specified laboratory adverse events severity grading scale - a full breakdown of the levels of severity of the reported events per study timepoint is available in the publication.

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Alanine transaminase · Normal	14 Participants	6 Participants	5 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Sodium · Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Platelet count · Abnormal	1 Participants	0 Participants	0 Participants	1 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Alanine transaminase · Abnormal	0 Participants	0 Participants	1 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Albumin · Normal	14 Participants	5 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Albumin · Abnormal	0 Participants	1 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Alkaline phosphatase · Normal	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Alkaline phosphatase · Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Bilirubin · Normal	10 Participants	5 Participants	5 Participants	5 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Bilirubin · Abnormal	4 Participants	1 Participants	1 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Creatinine · Normal	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Creatinine · Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Potassium · Normal	10 Participants	6 Participants	6 Participants	5 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Potassium · Abnormal	4 Participants	0 Participants	0 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Sodium · Normal	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Urea · Normal	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Urea · Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Eosinophil count · Normal	14 Participants	6 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Eosinophil count · Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Hemoglobin · Normal	12 Participants	5 Participants	6 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Hemoglobin · Abnormal	2 Participants	1 Participants	0 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Lymphocyte count · Normal	6 Participants	5 Participants	4 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Lymphocyte count · Abnormal	8 Participants	1 Participants	2 Participants	0 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Neutrophil count · Normal	9 Participants	6 Participants	4 Participants	5 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Neutrophil count · Abnormal	5 Participants	0 Participants	2 Participants	2 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities Platelet count · Normal	13 Participants	6 Participants	6 Participants	6 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities White blood cell count · Normal	14 Participants	6 Participants	5 Participants	7 Participants
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities White blood cell count · Abnormal	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At day 28

ELISA to quantify antibodies to filovirus glycoprotein (specific serological response). Peak antibody responses to both Ebola and Sudan viruses occurred 28 days post vaccination (or post-boost, in the participants who received a booster) across all groups.

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity Peak anti-EBOV antibody titers (occurred at D28)	260.1 ELISA units Interval 132.9 to 509.1	63.3 ELISA units Interval 7.2 to 555.0	164.2 ELISA units Interval 88.9 to 303.1	1169.7 ELISA units Interval 719.8 to 1902.5
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity Peak anti-SUDV antibody titers (occurred at D28)	111.5 ELISA units Interval 48.2 to 256.6	27.0 ELISA units Interval 4.9 to 148.5	101.7 ELISA units Interval 48.4 to 213.8	568.0 ELISA units Interval 296.4 to 1088.0

SECONDARY outcome

Timeframe: 14 days post final vaccine for each group

Intracellular cytokine staining (ICS) by flow cytometry was carried out at baseline as well as at 14 days after vaccination/boost to assess T-cell responses to Ebola virus glycoprotein and Sudan virus glycoprotein.

Outcome measures

Outcome measures
Measure	Group 3: High Dose - Single Dose n=14 Participants n=14 participants vaccinated with dose 1 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 1: Low Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 Participants n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose - Two Doses n=7 Participants n=7 participants vaccinated with dose 2 of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity Antigen-specific CD8+ T cells to EBOV	0.0850 frequency (proportion of parent cells) Interval 0.001 to 0.2075	0.0300 frequency (proportion of parent cells) Interval 0.009 to 0.0395	0.0000 frequency (proportion of parent cells) Interval 0.0 to 0.6945	0.1190 frequency (proportion of parent cells) Interval 0.0 to 0.3553
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity Antigen-specific CD8+ T cells to SUDV	0.1120 frequency (proportion of parent cells) Interval 0.0425 to 0.3495	0.0320 frequency (proportion of parent cells) Interval 0.015 to 0.0665	0.0340 frequency (proportion of parent cells) Interval 0.0 to 0.5415	0.0485 frequency (proportion of parent cells) Interval 0.0188 to 0.4538

Adverse Events

Group 1: Low Dose

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Group 2: Mid Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 3: High Dose 1

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Group 4: High Dose 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: Low Dose n=6 participants at risk n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 2: Mid Dose n=6 participants at risk n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 3: High Dose 1 n=14 participants at risk n=14 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Group 4: High Dose 2 n=7 participants at risk n=7 participants vaccinated with a second dose of ChAdOx1 biEBOV 5x10\^10 vp twelve weeks after the first ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Reproductive system and breast disorders Endometriotic cyst	16.7% 1/6 • Number of events 1 • Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.	0.00% 0/6 • Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.	0.00% 0/14 • Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.	0.00% 0/7 • Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.

Other adverse events

Additional Information

Dr. Paola Cicconi

University of Oxford

Phone: 01865 611425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place