Schistosomiasis
Conditions
Keywords
Dose-Escalation, Immunigenicity, Open-label, Phase I, Reactogenicity, Schistosomiasis, Vaccine
Brief summary
This is a Phase 1, open-label, dose-escalation clinical trial to evaluate the safety, reactogenicity, and immunogenicity of the Sm-p80+GLA-SE vaccine candidate in healthy adults between 18 and 55 years of age. Forty-five subjects will receive a series of three intramuscular injections 28 days apart with dose based on group. Five treatment groups, each including nine subjects, will receive three intramuscular (IM) injections of 0.5 mL of the designated study product on either Days 1, 29, and 57 or on Days 1, 29, and 180 (Table 1). Group A (unadjuvanted comparator) will receive 100 micrograms Sm-p80 alone on Days 1, 29, and 57, Group B (low dose standard schedule) will receive 10 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57, Group C (mid dose delayed booster) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 180, Group D (mid dose standard schedule) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29, and 57, and Group E (high dose standard schedule) will receive 100 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57. Study duration is approximately 20 months and will be conducted at one site in the US. Participant duration for subjects is 15 months. The primary objective is to assess the safety and reactogenicity following receipt of three doses of 1) 100 micrograms Sm- p80 (unadjuvanted), 2) 10 micrograms Sm-p80 + 5 micrograms GLA-SE, 3) 30 micrograms Sm-p80 + 5 micrograms GLA- SE, and 4) 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57 and 5) 30 micrograms Sm-p80 + 5 micrograms GLA- SE administered on Days 1, 29, and 180.
Detailed description
This is a Phase 1, open-label, dose-escalation clinical trial to evaluate the safety, reactogenicity, and immunogenicity of the Sm-p80+GLA-SE vaccine candidate in healthy adults between 18 and 55 years of age. Forty-five subjects will receive a series of three intramuscular injections 28 days apart with dose based on group. Five treatment groups, each including nine subjects, will receive three intramuscular (IM) injections of 0.5 mL of the designated study product on either Days 1, 29, and 57 or on Days 1, 29, and 180 (Table 1). Group A (unadjuvanted comparator) will receive 100 micrograms Sm-p80 alone on Days 1, 29, and 57, Group B (low dose standard schedule) will receive 10 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57, Group C (mid dose delayed booster) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 180, Group D (mid dose standard schedule) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29, and 57, and Group E (high dose standard schedule) will receive 100 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57. Study duration is approximately 20 months and will be conducted at one site in the US. Participant duration for subjects is 15 months. The primary objective is to assess the safety and reactogenicity following receipt of three doses of 1) 100 micrograms Sm- p80 (unadjuvanted), 2) 10 micrograms Sm-p80 + 5 micrograms GLA-SE, 3) 30 micrograms Sm-p80 + 5 micrograms GLA- SE, and 4) 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57 and 5) 30 micrograms Sm-p80 + 5 micrograms GLA- SE administered on Days 1, 29, and 180. The secondary objectives are to assess anti- Sm-p80 Immunoglobulin G (IgG) antibody responses for all subjects from samples collected at specified time points.
Interventions
BIOLOGICALSm-p80
The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection.
BIOLOGICALSm-p80 + GLA-SE
Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of consent. 2. Able and willing to participate for the duration of the study and able to understand and comply with planned study procedures. 3. Able and willing to provide written (not proxy) informed consent. 4. Is in good health, as judged by the investigator, and determined by medical history and physical examination\*. \*Existing medical diagnoses or conditions (except those in the Subject
Exclusion criteria
) must be deemed as stable. A stable medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last three months (90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last six months (180 days). Any change due to change of health care provider, insurance company, or that is done for financial reasons, as long as in the same class of medication, will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site PI or appropriate sub-investigator, will not be considered a violation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of solicited events and immunogenicity. Topical, nasal, and inhaled medications (with the exception of some uses of corticosteroids as outlined in the Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208 | Unsolicited adverse events (AEs) were defined as an untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs do not include solicited events that began within the reactogenicity period (7 days post dose). |
| Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208 | Hematology measurements include white blood cells (WBC), hemoglobin, and platelets. Labs were collected on vaccination days and 7 days and 28 days post each vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545 | SAEs were AEs that resulted in any of the following: Death, Life-threatening, Hospitalization, Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly/birth defect. Important medical events based upon appropriate medical judgment they could have jeopardized the participant and may have required intervention to prevent one of the outcomes listed. MAAEs were hospitalization, ER visit, or an otherwise unscheduled visit to or from medical personnel for any reason and considered related to study product. NOCMCs were any new ICD-10 diagnosis that applied to the participant during the duration of the study, after receipt of the study agent, that was expected to continue for at least 3 months and require continued health care intervention. PIMMCs were AEs that include diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies. |
| Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545 | An AE or suspected adverse reaction were considered an SAE if, in the view of either the principal investigator or the sponsor, resulted in any of the following outcomes: * Death, * A life-threatening AE, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect. * Important medical events that may not have resulted in death, been life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment they could have jeopardized the patient or participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | For Groups A, B, D, E: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through Day 36, Post Dose 3 Day 57 through 64. For Group C: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through 36, Post Dose 3 Day 180 through Day 187. | Systemic symptoms collected include arthralgia, chills, fatigue, fever, headache, malaise, myalgia, nausea, and vomiting. Injection site (local) symptoms collected include erythema/redness (measurement), induration/swelling (functional and measurement), pain, pruritus, and tenderness |
| Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208 | Chemistry measurements collected include alanine aminotransferase (ALT) and creatinine. Labs were collected on vaccination days and 7 days and 28 days post each vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Through 28 days after the first, second, and third study vaccinations. For Groups A, B, D, E: Day 8, 29, 36, 57, 64, and Day 85. For Group C: Day 8, 29, 36, 57, 180, 187, and Day 208. | Seroconversion was defined as a fourfold rise from baseline. |
| Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Through 7 and 28 days after each vaccination, and at 124 days after the last vaccination. For Groups A, B, D, E: Day 1, Day 8, 29, 36, 57, 64, 85, and Day 181. For Group C: Day 1, Day 8, 29, 36, 57, 180, 187, 208, and Day 304. | Geometric mean titers (GMTs). |
Countries
United States
Participant flow
Recruitment details
The study population includes 45 healthy adults ages 18 through 55 years who met all eligibility criteria. Participants were enrolled between 23May2022 to 24Jan2023.
Participants by arm
| Arm | Count |
|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. | 9 |
| Group B: 10 ug Sm-p80 + GLA-SE 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. | 9 |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. | 9 |
| Group D: 30 ug Sm-p80 + GLA-SE 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. | 9 |
| Group E: 100 ug Sm-p80 + GLA-SE 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. | 9 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group A: 100 ug Sm-p80 Unadjuvanted | Total | Group E: 100 ug Sm-p80 + GLA-SE | Group D: 30 ug Sm-p80 + GLA-SE | Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Group B: 10 ug Sm-p80 + GLA-SE |
|---|---|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 8.2 | 37.6 years STANDARD_DEVIATION 9.8 | 38.8 years STANDARD_DEVIATION 13 | 34.0 years STANDARD_DEVIATION 9.9 | 35.4 years STANDARD_DEVIATION 7.3 | 40.8 years STANDARD_DEVIATION 10 |
| BMI | 26.27 kg/m^2 STANDARD_DEVIATION 4.34 | 25.62 kg/m^2 STANDARD_DEVIATION 3.56 | 24.39 kg/m^2 STANDARD_DEVIATION 4.06 | 26.46 kg/m^2 STANDARD_DEVIATION 3.99 | 25.72 kg/m^2 STANDARD_DEVIATION 3.38 | 25.29 kg/m^2 STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 42 Participants | 8 Participants | 7 Participants | 9 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.58 cm STANDARD_DEVIATION 6.23 | 170.17 cm STANDARD_DEVIATION 7.46 | 171.33 cm STANDARD_DEVIATION 6.63 | 166.62 cm STANDARD_DEVIATION 5.67 | 168.14 cm STANDARD_DEVIATION 9.28 | 175.19 cm STANDARD_DEVIATION 7.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 38 Participants | 8 Participants | 6 Participants | 8 Participants | 8 Participants |
| Region of Enrollment United States | 9 participants | 45 participants | 9 participants | 9 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 26 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 19 Participants | 3 Participants | 3 Participants | 2 Participants | 5 Participants |
| Weight | 75.62 kg STANDARD_DEVIATION 13.94 | 74.32 kg STANDARD_DEVIATION 11.97 | 71.68 kg STANDARD_DEVIATION 13.27 | 73.59 kg STANDARD_DEVIATION 12.4 | 72.81 kg STANDARD_DEVIATION 11.38 | 77.89 kg STANDARD_DEVIATION 10.35 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose
Chemistry measurements collected include alanine aminotransferase (ALT) and creatinine. Labs were collected on vaccination days and 7 days and 28 days post each vaccination.
Time frame: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild events | 1 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 208 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 208 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 180 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild events | 1 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 187 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 180 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 187 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild events | 1 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
Primary
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose
Hematology measurements include white blood cells (WBC), hemoglobin, and platelets. Labs were collected on vaccination days and 7 days and 28 days post each vaccination.
Time frame: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild or Moderate Events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild or Moderate Events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild or Moderate Events | 1 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild or Moderate Events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild or Moderate Events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild or Moderate Events | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild or Moderate Events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild or Moderate Events | 3 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 7 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 6 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild or Moderate Events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild or Moderate Events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild or Moderate Events | 1 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 8 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild or Moderate Events | 2 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild or Moderate Events | 1 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild or Moderate Events | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 208 | No events | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild or Moderate Events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild or Moderate Events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 7 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild or Moderate Events | 2 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 208 | Mild or Moderate Events | 1 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild or Moderate Events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild or Moderate Events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 180 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 180 | Mild or Moderate Events | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 187 | No events | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 187 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild or Moderate Events | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild or Moderate Events | 1 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 9 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | Mild or Moderate Events | 1 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | No events | 6 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | Mild or Moderate Events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | Mild or Moderate Events | 1 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 36 | No events | 7 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | No events | 7 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 57 | Mild or Moderate Events | 1 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 64 | Mild or Moderate Events | 2 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 29 | No events | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | No events | 9 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 8 | Mild or Moderate Events | 1 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 1 | Mild or Moderate Events | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose | Day 85 | No events | 8 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs)
SAEs were AEs that resulted in any of the following: Death, Life-threatening, Hospitalization, Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly/birth defect. Important medical events based upon appropriate medical judgment they could have jeopardized the participant and may have required intervention to prevent one of the outcomes listed. MAAEs were hospitalization, ER visit, or an otherwise unscheduled visit to or from medical personnel for any reason and considered related to study product. NOCMCs were any new ICD-10 diagnosis that applied to the participant during the duration of the study, after receipt of the study agent, that was expected to continue for at least 3 months and require continued health care intervention. PIMMCs were AEs that include diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
Time frame: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | SAE | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | MAAE | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | NOCMC | 1 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | SAE | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | MAAE | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | MAAE | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | SAE | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | SAE | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | MAAE | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | PIMMC | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | NOCMC | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | MAAE | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) | SAE | 0 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study
An AE or suspected adverse reaction were considered an SAE if, in the view of either the principal investigator or the sponsor, resulted in any of the following outcomes: * Death, * A life-threatening AE, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect. * Important medical events that may not have resulted in death, been life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment they could have jeopardized the patient or participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study | 0 Participants |
Primary
Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose
Systemic symptoms collected include arthralgia, chills, fatigue, fever, headache, malaise, myalgia, nausea, and vomiting. Injection site (local) symptoms collected include erythema/redness (measurement), induration/swelling (functional and measurement), pain, pruritus, and tenderness
Time frame: For Groups A, B, D, E: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through Day 36, Post Dose 3 Day 57 through 64. For Group C: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through 36, Post Dose 3 Day 180 through Day 187.
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 1 | 9 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 3 | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 2 | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 2 | 7 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 1 | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 3 | 9 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 2 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 1 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 3 | 9 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 1 | 5 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 3 | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 2 | 7 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 2 | 6 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 1 | 9 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose | Post Dose 3 | 7 Participants |
Primary
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose
Unsolicited adverse events (AEs) were defined as an untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs do not include solicited events that began within the reactogenicity period (7 days post dose).
Time frame: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Moderate Events | 1 participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Mild Events | 3 participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Severe Events | 0 participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Severe Events | 0 participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Mild Events | 1 participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Moderate Events | 6 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Mild Events | 6 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Moderate Events | 1 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Severe Events | 0 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Moderate Events | 1 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Mild Events | 2 participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Severe Events | 0 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Severe Events | 0 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Moderate Events | 0 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Mild Events | 0 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Severe Events | 0 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Mild Events | 2 participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Moderate Events | 7 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Severe Events | 0 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Mild Events | 6 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Mild Events | 1 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Moderate Events | 1 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Moderate Events | 0 participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Severe Events | 1 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Mild Events | 3 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Moderate Events | 0 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Related Severe Events | 0 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Mild Events | 2 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Moderate Events | 3 participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose | Not Related Severe Events | 0 participants |
Secondary
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3
Geometric mean titers (GMTs).
Time frame: Through 7 and 28 days after each vaccination, and at 124 days after the last vaccination. For Groups A, B, D, E: Day 1, Day 8, 29, 36, 57, 64, 85, and Day 181. For Group C: Day 1, Day 8, 29, 36, 57, 180, 187, 208, and Day 304.
Population: The modified intention-to-treat (mITT) immunogenicity population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 8 | 22.668 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 29 | 32.515 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 36 | 120.194 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 181 | 514.170 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 57 | 228.496 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 64 | 498.632 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 1 (Pre-Dose 1) | 24.659 titer of serum antibodies |
| Group A: 100 ug Sm-p80 Unadjuvanted | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 85 | 1186.982 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 85 | 4254.894 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 36 | 226.177 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 181 | 1412.534 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 64 | 1475.325 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 29 | 34.058 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 8 | 26.915 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 57 | 868.743 titer of serum antibodies |
| Group B: 10 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 1 (Pre-Dose 1) | 29.209 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 304 | 1471.551 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 29 | 139.103 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 1 (Pre-Dose 1) | 74.704 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 36 | 1079.771 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 57 | 2691.534 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 180 | 376.322 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 187 | 2610.156 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 208 | 16343.056 titer of serum antibodies |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 8 | 66.900 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 57 | 868.512 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 8 | 28.233 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 1 (Pre-Dose 1) | 29.884 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 36 | 489.783 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 85 | 4073.814 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 64 | 4062.047 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 29 | 44.900 titer of serum antibodies |
| Group D: 30 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 181 | 439.870 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 36 | 420.482 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 1 (Pre-Dose 1) | 26.235 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 8 | 16.887 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 29 | 49.354 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 57 | 1659.587 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 64 | 3620.347 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 85 | 4479.711 titer of serum antibodies |
| Group E: 100 ug Sm-p80 + GLA-SE | Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 | Day 181 | 985.714 titer of serum antibodies |
Secondary
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose
Seroconversion was defined as a fourfold rise from baseline.
Time frame: Through 28 days after the first, second, and third study vaccinations. For Groups A, B, D, E: Day 8, 29, 36, 57, 64, and Day 85. For Group C: Day 8, 29, 36, 57, 180, 187, and Day 208.
Population: The modified intention-to-treat (mITT) immunogenicity population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 8 | 0 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 64 | 8 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 57 | 5 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 36 | 4 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 29 | 1 Participants |
| Group A: 100 ug Sm-p80 Unadjuvanted | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 85 | 8 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 29 | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 8 | 0 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 64 | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 85 | 9 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 36 | 6 Participants |
| Group B: 10 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 57 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 187 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 29 | 2 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 180 | 6 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 57 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 36 | 8 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 8 | 0 Participants |
| Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 208 | 8 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 36 | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 29 | 1 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 64 | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 85 | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 57 | 7 Participants |
| Group D: 30 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 8 | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 29 | 2 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 8 | 0 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 64 | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 36 | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 57 | 8 Participants |
| Group E: 100 ug Sm-p80 + GLA-SE | Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose | Day 85 | 8 Participants |