A Phase 1 interventional study of rSm-p80 + GLA-SE in Schistosomiasis, sponsored by International Vaccine Institute. Completed at 2 sites in 2 countries. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by International Vaccine Institute · Phase 1, Interventional, and Prevention
The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated.
A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 µg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 µg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 µg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio. A subset of five out of 20 subjects in each cohort will be sampled by convenience to enable us to further characterize the immune response using the peripheral blood mononuclear cells (PBMC). The Primary Objective of the study is to evaluate the safety and tolerability of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine given intramuscularly on D0, D28 and D56 to healthy participants 20 to 59 years of age in Burkina Faso and Madagascar.
This is a phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study, assessing the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated. A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60), as shown in the Table 1, below. Cohort A will receive the low-dose antigen formulation (10 µg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 µg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 µg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio. A subset of five out of 20 subjects in each cohort will be sampled by convenience to enable us to further characterize the immune response using the peripheral blood mononuclear cells (PBMC).
To ensure that the study participants at enrollment do not have any active schistosomiasis or helminth infection and are schistosomiasis egg-negative, pre-screening activities including schistosomiasis treatment will be carried out in potential study participants prior to enrollment. Potential study participants will be identified in the catchment population and will be offered anti-helminth treatment using praziquantel (PZQ) and Albendazole (ABZ) as per local guidelines at study site. The pre-screening visit will be conducted 6-8 weeks before the screening visit. The last dose of PZQ/ABZ will be administered at least 5 weeks prior to the first dose of study product.
The Primary objective is to evaluate the safety and tolerability of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine given intramuscularly on D0, D28 and D56 to healthy participants 20 to 59 years of age in Burkina Faso and Madagascar.
The Secondary objective is to evaluate the immunogenicity of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine 28 days post-vaccination on D28, D56, and D84 as compared with the baseline and with those who received placebo.
The Exploratory objective is to describe the antigen-specific B- and T-cell responses, memory responses, and innate and adaptive immune signatures from samples collected at specified timepoints.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 120 is below the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort A will receive the low-dose antigen formulation(10 μg rSm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 40 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Biological: rSm-p80 + GLA-SE
Cohort B will receive the medium-dose antigen formulation(30 μg rSm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 40 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Biological: rSm-p80 + GLA-SE
Cohort C will receive the high-dose antigen formulation(100 μg rSm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 40 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Biological: rSm-p80 + GLA-SE
Combination vaccine containing rSm-p80 antigen and GLA-SE adjuvant.
Proportion of Participants With of Any Serious Adverse Events (SAEs)/ Adverse Events of Special Interest (AESI) From the Time of the First Study Vaccination Through the Final Study Visit.
Serious Adverse Events (SAE) An AE or suspected adverse reaction is considered "serious" if at any dose (including overdose): Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect ; or Is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. Adverse Event of Special Interest (AESI) are AEs that are considered by the sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
Time frame: Day 1 through Day 224
Proportion of Participants With Immediate Adverse Events (Reactogenicity Events) Within 60 Min From the Time of Each Study Vaccination
Immediate adverse events collected within 60 mins from the time of each study vaccination Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
Time frame: Day 1 through Day 56
Proportion of Participants With Solicited Local and Solicited Systemic AEs as Measured for 7 Days (Inclusive) Following Immunization With the Three Different Dose Formulations.
Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
Time frame: Day 1 through Day 63
Proportion of Participants With Unsolicited AEs From the Time of Vaccination Until 28 Days Post Immunization With the Three Different Dose Formulations.
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 are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
Time frame: Day 1 through Day 84
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
Clinical laboratory safety measurements collected include: Hematology \[Complete blood count (CBC) with automated differential\]: White blood cell (WBC) count, Red Blood Cell count (RBC), hemoglobin, and platelet count. Serum chemistry: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST), Total Bilirubin (TB), Creatinine (CREAT), and C-reactive protein (CRP). Urine samples were be tested by dipstick for blood, glucose and protein. Labs samples were collected at screening and on vaccination days and 7 days and 28 days post each vaccination.
Time frame: Day 1 through Day 84
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 4 Weeks (28 Days) After Each Dose of Study Vaccination as Compared to Baseline
Seroconversion was defined as a fourfold rise from baseline.
Time frame: Through 28 days after the first, second, and third study vaccinations
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 24 Weeks After Third Dose of Study Vaccination as Compared to Baseline
Seroconversion was defined as a fourfold rise from baseline.
Time frame: Through 24 weeks after third dose of study vaccination
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 4 Weeks After Each Dose of Study Vaccination.
Geometric mean titers (GMTs).
Time frame: Through 28 days after the first, second, and third study vaccinations
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 24 Weeks After Third Dose of Study Vaccination.
Geometric Mean Titers (GMTs)
Time frame: Through 24 weeks after third dose of study vaccination.
The Study population includes 120 healthy adults ages 20 through 59 years who met all eligibility criteria (60 participants per site). Participants were enrolled between 17 Nov 2023 to 11 Oct 2024.
| Milestone | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Started | 30 | 30 | 30 | 30 |
| Completed | 29 | 30 | 29 | 30 |
| Not completed | 1 | 0 | 1 | 0 |
| Withdrew: Pregnancy | 1 | 0 | 1 | 0 |
Serious Adverse Events (SAE) An AE or suspected adverse reaction is considered "serious" if at any dose (including overdose): Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect ; or Is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. Adverse Event of Special Interest (AESI) are AEs that are considered by the sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Proportion of Participants With of Any Serious Adverse Events (SAEs)/ Adverse Events of Special Interest (AESI) From the Time of the First Study Vaccination Through the Final Study Visit. | 1 | 1 | 0 | 0 |
Immediate adverse events collected within 60 mins from the time of each study vaccination Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Post Dose 1 | 6 | 11 | 6 | 2 |
| Post Dose 2 | 6 | 8 | 4 | 3 |
| Post Dose 3 | 7 | 7 | 1 | 0 |
Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Post Dose 1 | 16 | 10 | 7 | 4 |
| Post Dose 2 | 10 | 16 | 5 | 5 |
| Post Dose 3 | 9 | 9 | 3 | 1 |
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 are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Post Dose 1 | 9 | 8 | 8 | 13 |
| Post Dose 2 | 9 | 10 | 7 | 11 |
| Post Dose 3 | 6 | 10 | 8 | 4 |
Clinical laboratory safety measurements collected include: Hematology \[Complete blood count (CBC) with automated differential\]: White blood cell (WBC) count, Red Blood Cell count (RBC), hemoglobin, and platelet count. Serum chemistry: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST), Total Bilirubin (TB), Creatinine (CREAT), and C-reactive protein (CRP). Urine samples were be tested by dipstick for blood, glucose and protein. Labs samples were collected at screening and on vaccination days and 7 days and 28 days post each vaccination.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| 7 Days post Dose 1 | 4 | 1 | 0 | 3 |
| 28 Days post Dose 1 | 1 | 0 | 0 | 1 |
| 7 Days post Dose 2 | 1 | 0 | 1 | 2 |
| 28 Days post Dose 2 | 0 | 1 | 0 | 0 |
| 7 Days post Dose 3 | 0 | 0 | 0 | 0 |
| 28 Days post Dose 3 | 1 | 0 | 1 | 0 |
Seroconversion was defined as a fourfold rise from baseline.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Day 28 post dose 1 | 1 | 9 | 12 | 0 |
| Day 28 post dose 2 | 20 | 28 | 29 | 4 |
| Day 28 post dose 3 | 23 | 28 | 29 | 2 |
Seroconversion was defined as a fourfold rise from baseline.
| Participants | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 24 Weeks After Third Dose of Study Vaccination as Compared to Baseline | 25 | 25 | 23 | 8 |
Geometric mean titers (GMTs).
| titer of serum antibodies | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Day 28 post dose 1 | 75.79 (63.64 to 90.25) | 144.73 (105.42 to 198.69) | 166.25 (119.22 to 231.83) | 62.00 (54.76 to 70.19) |
| Day 28 post dose 2 | 620.46 (299.82 to 1283.99) | 2015.87 (1130.85 to 3593.54) | 1837.92 (1118.44 to 3020.23) | 91.17 (70.87 to 117.29) |
| Day 28 post dose 3 | 1969.83 (888.64 to 4366.50) | 4422.12 (2374.16 to 8236.65) | 2425.15 (1381.16 to 4258.26) | 91.17 (66.41 to 125.16) |
Geometric Mean Titers (GMTs)
| titer of serum antibodies | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 24 Weeks After Third Dose of Study Vaccination. | 918.96 (513.32 to 1645.13) | 857.42 (492.88 to 1491.57) | 578.91 (369.31 to 907.45) | 123.11 (83.74 to 181.00) |
Collected over Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | 0/30 (0%) | 1/30 (3.3%) | 16/30 (53.3%) |
| Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | 0/30 (0%) | 1/30 (3.3%) | 21/30 (70%) |
| Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | 0/30 (0%) | 0/30 (0%) | 22/30 (73.3%) |
| Placebo Group | 0/30 (0%) | 0/30 (0%) | 19/30 (63.3%) |
| Event | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| Abortion Not Otherwise SpecifiedPregnancy, puerperium and perinatal conditions | 1/30 | 0/30 | 0/30 | 0/30 |
| Febrile PneumopathyRespiratory, thoracic and mediastinal disorders | 0/30 | 1/30 | 0/30 | 0/30 |
| Event | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group |
|---|---|---|---|---|
| InfluenzaInfections and infestations | 5/30 | 4/30 | 11/30 | 7/30 |
| MalariaInfections and infestations | 2/30 | 5/30 | 3/30 | 1/30 |
| RhinitisInfections and infestations | 2/30 | 4/30 | 0/30 | 0/30 |
| ToothacheGastrointestinal disorders | 2/30 | 3/30 | 1/30 | 3/30 |
| LeukopeniaBlood and lymphatic system disorders | 3/30 | 1/30 | 1/30 | 2/30 |
| Abdominal pain upperGastrointestinal disorders | 0/30 | 2/30 | 0/30 | 0/30 |
| DiarrhoeaGastrointestinal disorders | 0/30 | 0/30 | 1/30 | 2/30 |
| HypercreatinaemiaMusculoskeletal and connective tissue disorders | 2/30 | 0/30 | 0/30 | 1/30 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/30 | 2/30 | 1/30 | 2/30 |
| Alanine aminotransferase increasedInvestigations | 0/30 | 0/30 | 2/30 | 1/30 |
| Age, Continuous(years) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 36.50 ± 12.42 | 32.37 ± 9.80 | 34.80 ± 10.52 | 35.13 ± 11.33 | 34.70 ± 11.02 |
| Sex: Female, Male(Participants) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Female | 19 | 21 | 21 | 21 | 82 |
| Male | 11 | 9 | 9 | 9 | 38 |
| Race and Ethnicity Not Collected(Participants) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Burkina Faso | 15 | 15 | 15 | 15 | 60 |
| Madagascar | 15 | 15 | 15 | 15 | 60 |
| Height(cm) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 162.11 ± 6.99 | 161.54 ± 8.43 | 161.05 ± 7.99 | 161.41 ± 10.71 | 161.53 ± 8.54 |
| Weight(kg) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 56.90 ± 11.48 | 61.00 ± 10.19 | 54.92 ± 10.84 | 58.99 ± 11.32 | 57.95 ± 11.07 |
| BMI(kg/m^2) | Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE) | Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE) | Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE) | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 21.73 ± 4.71 | 23.43 ± 4.03 | 20.98 ± 2.71 | 22.58 ± 3.16 | 22.18 ± 3.80 |
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International Vaccine Institute