Malaria, Vivax
Conditions
Keywords
Pvs25-IMX313, Matrix-M1
Brief summary
This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
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 18 months. All volunteers will receive three doses of Pvs25-IMX313 in Matrix-M1, 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
BIOLOGICALPvs25-IMX313/Matrix-M1
Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations
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. Acceptable forms of contraception for volunteers of child-bearing potential are: Established use of oral, injected or implanted hormonal methods of contraception, Placement of an intrauterine device or intrauterine system, Male sterilization (if the vasectomised partner is the sole partner for the participant), True abstinence from sex with sperm-producing partners, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence and withdrawal are not acceptable methods of contraception). * 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 Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events | Whole duration of the study period (8 months following enrolment) | Number of serious adverse events reported per group throughout the study period. |
| Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | 7 days following each vaccination | Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries. |
| Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | 7 days following each vaccination | Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries. |
| Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | 28 days following each vaccination | Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries. |
| Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | 28 days following vaccination | Occurrence of change from baseline laboratory test results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein. | Days 1, 29, 57, 140 and 240. | T cell responses to Pvs25 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) and flow cytometry assays. |
| Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity | Days 1, 29, 57, 140 and 240. | Transmission-reducing activity will be assessed through direct membrane feeding assays (DMFA). |
| Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity | Days 1, 29, 57, 140 and 240. | Transmission-blocking activity will be assessed through direct membrane feeding assays (DMFA). |
| Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein | Days 1, 29, 57, 140 and 240. | Antibody responses to the Pvs25 protein will be assessed through total IgG isotypes and avidity |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Low Dose) 8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm | 8 |
| Group 2 (Standard Dose) 9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm | 9 |
| Group 3 (Fractional Dose) 8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm | 8 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 (Low Dose) | Group 2 (Standard Dose) | Group 3 (Fractional Dose) | Total |
|---|---|---|---|---|
| Age, Customized Age | 29.5 years | 32 years | 27 years | 29 years |
| Race/Ethnicity, Customized Asian or Asian British | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or Black British - African | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Asian Background | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White British | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized White Irish | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White Other | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 5 Participants | 12 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 / 9 | 0 / 8 |
| other Total, other adverse events | 8 / 8 | 9 / 9 | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Time frame: 7 days following each vaccination
Population: Percentages are the proportion of participants in each group that reported each symptom after at least one vaccination.~Group 1: All participants received three vaccinations Group 2: 9 participants received vaccinations 1 and 2, 7 participants received vaccination 3 Group 3: 8 participants received vaccinations 1 and 2, 6 participants received vaccination 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Mild | 8 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Mild | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Mild | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Mild | 1 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Mild | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Mild | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Mild | 7 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Moderate | 3 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Mild | 3 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Mild | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Redness: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Warmth: Mild | 3 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Pain: Mild | 5 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms | Itch: Mild | 0 Participants |
Primary
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Time frame: 7 days following each vaccination
Population: Percentages are the proportion of participants in each group that reported each symptom after at least one vaccination.~Group 1: All participants received three vaccinations Group 2: 9 participants received vaccinations 1 and 2, 7 participants received vaccination 3 Group 3: 8 participants received vaccinations 1 and 2, 6 participants received vaccination 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Mild | 2 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Mild | 7 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Moderate | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Mild | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Moderate | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Mild | 3 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Moderate | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Mild | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Moderate | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Mild | 2 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Mild | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Moderate | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Severe | 0 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Mild | 6 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Moderate | 1 Participants |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Mild | 3 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Mild | 2 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Mild | 1 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Moderate | 2 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Mild | 7 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Mild | 4 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Severe | 1 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Moderate | 4 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Severe | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Mild | 4 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Mild | 4 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Mild | 1 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Moderate | 0 Participants |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Moderate | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Mild | 5 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Moderate | 3 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Moderate | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Malaise: Severe | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Moderate | 3 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Mild | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Moderate | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fever: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Mild | 4 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Mild | 3 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Moderate | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Arthralgia: Severe | 0 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Headache: Mild | 5 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Mild | 6 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Moderate | 2 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Feverishness: Severe | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Fatigue: Severe | 1 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Myalgia: Mild | 5 Participants |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms. | Nausea: Mild | 2 Participants |
Primary
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Number of serious adverse events reported per group throughout the study period.
Time frame: Whole duration of the study period (8 months following enrolment)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events | 0 Number of serious adverse events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events | 0 Number of serious adverse events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events | 0 Number of serious adverse events |
Primary
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Time frame: 28 days following each vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | Total unsolicited adverse events (UAEs) | 56 Number of events |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - no relationship to investigational vaccine | 26 Number of events |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - unlikely related to investigational vaccine | 22 Number of events |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - possibly related to investigational vaccine | 5 Number of events |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - probably related to investigational vaccine | 3 Number of events |
| Group 1 (Low Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - definitely related to investigational vaccine | 0 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - definitely related to investigational vaccine | 0 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | Total unsolicited adverse events (UAEs) | 54 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - possibly related to investigational vaccine | 12 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - probably related to investigational vaccine | 1 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - no relationship to investigational vaccine | 20 Number of events |
| Group 2 (Standard Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - unlikely related to investigational vaccine | 21 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - no relationship to investigational vaccine | 14 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - unlikely related to investigational vaccine | 31 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - definitely related to investigational vaccine | 0 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - possibly related to investigational vaccine | 6 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | Total unsolicited adverse events (UAEs) | 53 Number of events |
| Group 3 (Fractional Dose) | Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events. | UAEs - probably related to investigational vaccine | 2 Number of events |
Primary
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Occurrence of change from baseline laboratory test results
Time frame: 28 days following vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Low Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 2 laboratory abnormalities | 3 Number of abnormal laboratory results |
| Group 1 (Low Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 1 laboratory abnormalities | 47 Number of abnormal laboratory results |
| Group 1 (Low Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 3 laboratory abnormalities | 0 Number of abnormal laboratory results |
| Group 2 (Standard Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 2 laboratory abnormalities | 5 Number of abnormal laboratory results |
| Group 2 (Standard Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 1 laboratory abnormalities | 25 Number of abnormal laboratory results |
| Group 2 (Standard Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 3 laboratory abnormalities | 2 Number of abnormal laboratory results |
| Group 3 (Fractional Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 1 laboratory abnormalities | 21 Number of abnormal laboratory results |
| Group 3 (Fractional Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 3 laboratory abnormalities | 1 Number of abnormal laboratory results |
| Group 3 (Fractional Dose) | Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results | Grade 2 laboratory abnormalities | 4 Number of abnormal laboratory results |
Secondary
Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein.
T cell responses to Pvs25 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) and flow cytometry assays.
Time frame: Days 1, 29, 57, 140 and 240.
Secondary
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity
Transmission-blocking activity will be assessed through direct membrane feeding assays (DMFA).
Time frame: Days 1, 29, 57, 140 and 240.
Secondary
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity
Transmission-reducing activity will be assessed through direct membrane feeding assays (DMFA).
Time frame: Days 1, 29, 57, 140 and 240.
Secondary
Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein
Antibody responses to the Pvs25 protein will be assessed through total IgG isotypes and avidity
Time frame: Days 1, 29, 57, 140 and 240.