Malaria, Plasmodium Falciparum
Conditions
Keywords
Pfs48/45, Matrix-M
Brief summary
This is an open label, single-site, first-in-human, dose-escalation Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs48/45 in Matrix-M adjuvant in healthy adults living in the UK
Detailed description
Volunteers will be recruited into one of three groups (n=8-10 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford over approximately 12 months. All volunteers will receive three dose of Pfs48/45 in 50 µg Matrix-M, administered intramuscularly and given four weeks apart. Enrolment will be staggered with clinical and safety reviews, follow-up visits and monitoring via a diary card.
Interventions
BIOLOGICALPfs48/45 in Matrix-M
Three doses of Pfs48/45 in Matrix-M at different doses
Sponsors
University of Oxford
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult aged 18 to 45 years. * Able and willing (in the Investigator's opinion) to comply with all study requirements. * Willing to allow the Investigators to discuss the volunteer's medical history with their GP. * Volunteers with the potential to become pregnant only: must practice continuous effective contraception for the duration of the study (see section 10.10). * Agreement to refrain from blood donation for the duration of the study. * Able and willing to provide written informed consent to participate in the trial
Exclusion criteria
* History of clinical malaria (any species). * Travel to a clearly malaria endemic locality during the study period or within the preceding six months. * Use of immunoglobulins or blood products (e.g., blood transfusion) in the last three months. * Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination. * Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period. * Concurrent involvement in another clinical trial or planned involvement during the study period. * Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Any history of anaphylaxis in reaction to vaccinations. * Pregnancy, lactation or intention to become pregnant during the study. * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). * History of serious psychiatric condition that may affect participation in the study. * Any other serious chronic illness requiring hospital specialist supervision. * Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week. * Suspected or known injecting drug abuse in the 5 years preceding enrolment. * Hepatitis B surface antigen (HBsAg) detected in serum. * Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study). * Volunteers unable to be closely followed for social, geographic or psychological reasons. * Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | 7 days following each vaccination | Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results |
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | 7 days following each vaccination | Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results. |
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | 28 days following the vaccination | Number of unsolicited adverse events (AEs) for 28 days following the vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results |
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | 28 days following vaccination | Occurrence of change from baseline laboratory tests |
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events | Whole duration of the study (8 months following initial trial vaccination) | Occurrence of serious adverse events will be presented according to local grading scales |
| Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. | Whole duration of the study (8 months following initial trial vaccination) | Occurrence of AEs of special interest will be presented according to local grading scales and will be described in detail |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Humoral Responses to the Pfs48/45 Protein | Days 1, 29, 57, 140 and 240 | Antibody responses to the Pfs48/45 protein will be assessed through total IgG isotypes and avidity |
| Cellular Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Cellular Responses to the Pfs48/45 Protein | Days 1, 29, 57, 140 and 240 | T cell responses to Pfs48/45 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) |
| Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-reducing Activity | Days 1, 29, 57, 140 and 240 | Transmission-reducing activity |
| Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-blocking Activity | Days 1, 29, 57, 140 and 240 | Transmission-blocking activity |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORAngela M Minassian, DPhil FRCP
Center for Clinical Vaccinology and Tropical Medicine, University of Oxford
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Low Dose 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses | 8 |
| Group 2 - Standard Dose 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses | 8 |
| Group 3 - Fractional Dose 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm
Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses | 1 |
| Total | 17 |
Baseline characteristics
| Characteristic | Group 1 - Low Dose | Group 2 - Standard Dose | Group 3 - Fractional Dose | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 1 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian or Asian British - Bangladeshi | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Asian background | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - British | 4 Participants | 7 Participants | 1 Participants | 12 Participants |
| Race/Ethnicity, Customized White - Other | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United Kingdom | 8 participants | 8 participants | 1 participants | 17 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 0 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 1 |
| other Total, other adverse events | 7 / 8 | 7 / 8 | 1 / 1 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 1 |
Outcome results
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers.
Occurrence of AEs of special interest will be presented according to local grading scales and will be described in detail
Time frame: Whole duration of the study (8 months following initial trial vaccination)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. | 0 Participants |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. | 0 Participants |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. | 0 Participants |
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results
Occurrence of change from baseline laboratory tests
Time frame: 28 days following vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Severe abnormalities | 0 Number of participants with events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Moderate abnormalities | 0 Number of participants with events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Mild abnormalities | 5 Number of participants with events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Severe abnormalities | 0 Number of participants with events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Mild abnormalities | 4 Number of participants with events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Moderate abnormalities | 1 Number of participants with events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Moderate abnormalities | 0 Number of participants with events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Mild abnormalities | 0 Number of participants with events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results | Severe abnormalities | 0 Number of participants with events |
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events
Occurrence of serious adverse events will be presented according to local grading scales
Time frame: Whole duration of the study (8 months following initial trial vaccination)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events | 0 Participants |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events | 0 Participants |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events | 0 Participants |
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results
Time frame: 7 days following each vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Mild) | 7 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Moderate) | 2 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Mild) | 4 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Moderate) | 1 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Mild) | 2 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Moderate) | 1 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Redness | 7 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Mild) | 6 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Moderate) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Moderate) | 3 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Redness | 5 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Moderate) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Mild) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Mild) | 6 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Warmth (Severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Itch (Mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Redness | 1 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Pain (Severe) | 0 Number of participants reporting events |
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results.
Time frame: 7 days following each vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (mild) | 2 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (moderate) | 2 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (mild) | 6 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (moderate) | 3 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (mild) | 5 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (moderate) | 4 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (mild) | 6 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (mild) | 5 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (mild) | 5 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (moderate) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (moderate) | 3 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (moderate) | 3 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (mild) | 2 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (severe) | 0 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (moderate) | 3 Number of participants reporting events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (severe) | 1 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (mild) | 6 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (mild) | 3 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (moderate) | 2 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (mild) | 5 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (moderate) | 2 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (severe) | 1 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (mild) | 3 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (moderate) | 2 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (mild) | 7 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (moderate) | 4 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (moderate) | 3 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (mild) | 3 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (moderate) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (severe) | 0 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (mild) | 7 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (moderate) | 1 Number of participants reporting events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Myalgia (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Malaise (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (mild) | 1 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Nausea (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Arthralgia (moderate) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Headache (severe) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fever (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (mild) | 0 Number of participants reporting events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Systemic Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination | Fatigue (moderate) | 0 Number of participants reporting events |
Primary
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination
Number of unsolicited adverse events (AEs) for 28 days following the vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results
Time frame: 28 days following the vaccination
Population: A full list of unsolicited adverse events and the number of participants affected by each event is available in the 'Adverse events' section.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - unlikely related to the IMP | 26 Number of events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - possibly related to the IMP | 13 Number of events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - definitely related to the IMP | 0 Number of events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - probably related to the IMP | 7 Number of events |
| Group 1 - Low Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - no relationship to the IMP | 8 Number of events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - possibly related to the IMP | 5 Number of events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - definitely related to the IMP | 0 Number of events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - probably related to the IMP | 3 Number of events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - unlikely related to the IMP | 9 Number of events |
| Group 2 - Standard Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - no relationship to the IMP | 6 Number of events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - no relationship to the IMP | 0 Number of events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - unlikely related to the IMP | 0 Number of events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - definitely related to the IMP | 1 Number of events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - possibly related to the IMP | 0 Number of events |
| Group 3 - Fractional Dose | Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination | Unsolicited adverse events - probably related to the IMP | 0 Number of events |
Secondary
Cellular Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Cellular Responses to the Pfs48/45 Protein
T cell responses to Pfs48/45 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot)
Time frame: Days 1, 29, 57, 140 and 240
Secondary
Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-blocking Activity
Transmission-blocking activity
Time frame: Days 1, 29, 57, 140 and 240
Secondary
Ex Vivo Efficacy of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers Using Direct Membrane Feeding Assays as Assessed by Transmission-reducing Activity
Transmission-reducing activity
Time frame: Days 1, 29, 57, 140 and 240
Secondary
Humoral Immunogenicity of the Pfs48/45 With Matrix-M Vaccine, When Administered to Healthy Adult Volunteers as Assessed by Humoral Responses to the Pfs48/45 Protein
Antibody responses to the Pfs48/45 protein will be assessed through total IgG isotypes and avidity
Time frame: Days 1, 29, 57, 140 and 240