Trial Outcomes & Findings for A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant (NCT NCT02925403)

Last Updated: 2019-11-06

Results Overview

Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Assessment of solicited AEs in the first 7 days post vaccination.

Results posted on

2019-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 Saline injection on days 0, 28, and 56. Saline
Overall Study STARTED	8	5
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 Saline injection on days 0, 28, and 56. Saline
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=8 Participants 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 Participants Saline injection on days 0, 28, and 56. Saline	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants	5 Participants n=5 Participants	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=13 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	5 Participants n=5 Participants	8 Participants n=13 Participants
Sex: Female, Male Male	5 Participants n=8 Participants	0 Participants n=5 Participants	5 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Burkina Faso	8 participants n=8 Participants	5 participants n=5 Participants	13 participants n=13 Participants

PRIMARY outcome

Timeframe: Assessment of solicited AEs in the first 7 days post vaccination.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 Participants Saline injection on days 0, 28, and 56. Saline
Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.	10 Number of adverse events	0 Number of adverse events

PRIMARY outcome

Timeframe: Unsolicited AEs to be assessed up to 28 days post vaccination.

Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 Participants Saline injection on days 0, 28, and 56. Saline
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.	8 participants	5 participants

PRIMARY outcome

Timeframe: 6 months

Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 Participants Saline injection on days 0, 28, and 56. Saline
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.	0 SAEs	0 SAEs

PRIMARY outcome

Timeframe: At Day 0 (baseline), day 7 and day 28 post vaccination.

Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 Participants Saline injection on days 0, 28, and 56. Saline
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.	18 Laboratory AEs	15 Laboratory AEs

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 5 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

Phone: +44 1865 617610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=8 participants at risk 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1	Group 2 n=5 participants at risk Saline injection on days 0, 28, and 56. Saline
Respiratory, thoracic and mediastinal disorders Rhinitis	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Respiratory, thoracic and mediastinal disorders Bronchitis	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Enteritis	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Epigastralgia	12.5% 1/8 • 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.	40.0% 2/5 • 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.
Eye disorders Ocular hyperhemia	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Reproductive system and breast disorders Epididymitis	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Skin and subcutaneous tissue disorders Furuncle	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Respiratory, thoracic and mediastinal disorders Sore throat	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Infections and infestations Teeth decay	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Eye disorders Conjunctivitis	0.00% 0/8 • 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.	20.0% 1/5 • 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.
General disorders Headache	25.0% 2/8 • 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.	0.00% 0/5 • 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.
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • 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.	0.00% 0/5 • 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.
Blood and lymphatic system disorders Neutropaenia	37.5% 3/8 • 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.	60.0% 3/5 • 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.
Renal and urinary disorders Elevated Creatinine	12.5% 1/8 • 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.	20.0% 1/5 • 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.
Skin and subcutaneous tissue disorders Swelling	25.0% 2/8 • 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.	0.00% 0/5 • 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.
Skin and subcutaneous tissue disorders Redness	12.5% 1/8 • 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.	0.00% 0/5 • 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.
General disorders Pain	25.0% 2/8 • 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.	0.00% 0/5 • 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.
Musculoskeletal and connective tissue disorders Joint pain	25.0% 2/8 • 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.	0.00% 0/5 • 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.
Hepatobiliary disorders Elevated ALT	0.00% 0/8 • 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.	20.0% 1/5 • 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.