Trial Outcomes & Findings for Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination (NCT NCT02485912)

Last Updated: 2019-02-06

Results Overview

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed for both groups: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of serious adverse events during the whole study duration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

26 weeks

Results posted on

2019-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Group 2 ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Group 2 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	7 Participants n=20 Participants	4 Participants n=20 Participants	11 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=20 Participants	16 Participants n=20 Participants	29 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Senegal	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 26 weeks

Outcome measures

Outcome measures
Measure	Group 1 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Group 2 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events.	20 participants	20 participants

SECONDARY outcome

Timeframe: 26 weeks

Ebolavirus specific immunogenicity will be assessed by a variety of immunological assays. The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses. Exploratory outcome measures will include ex-vivo ELISPOT, plasma blast assays and flow cytometry performed with research samples collected at different study timepoints as well as other immunogenicity assays throughout the study. An evaluation of genetic factors associated with immune responses may be performed as exploratory evaluation. Vaccine-induced mRNA expression profiles during 1 week after vaccination may also be performed as an exploratory evaluation.

Outcome measures

Outcome measures
Measure	Group 1 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Group 2 n=20 Participants ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years	20 participants	20 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Adrian V Hill, DPhil FRCP

University of Oxford

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=20 participants at risk ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein	Group 2 n=20 participants at risk ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. ChAd3-EBO Z: This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein MVA-EBO Z: This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
Vascular disorders headache	40.0% 8/20 • Number of events 9 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	20.0% 4/20 • Number of events 4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Blood and lymphatic system disorders anaemia	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Musculoskeletal and connective tissue disorders arthralgia	20.0% 4/20 • Number of events 6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders Pain	65.0% 13/20 • Number of events 18 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	50.0% 10/20 • Number of events 12 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders warmth	30.0% 6/20 • Number of events 6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders itching	20.0% 4/20 • Number of events 4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders redness	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Nervous system disorders myalgia	25.0% 5/20 • Number of events 6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	15.0% 3/20 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders fatigue	40.0% 8/20 • Number of events 9 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	10.0% 2/20 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders nausea	10.0% 2/20 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders malaise	15.0% 3/20 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Blood and lymphatic system disorders Hyperbilirubinemia	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Immune system disorders neutropenia	10.0% 2/20 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	10.0% 2/20 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders Feverish	15.0% 3/20 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders Dysmenorrhea	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders feverish/chills	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders tooth pain	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders unwell	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.
General disorders diarrhoea	0.00% 0/20 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.	5.0% 1/20 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit. There was no serious adverse event.