SchistosomiasisPhase 1NCT05292391
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
A Phase 1 study testing Sm-p80 and Sm-p80 + GLA-SE in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Sm-p80 and Sm-p80 + GLA-SE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 19 Mar 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of consent.
- Able and willing to participate for the duration of the study and able to understand and comply with planned study procedures.
- Able and willing to provide written (not proxy) informed consent.
- 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 Exclusion Criteria), vitamins, and contraceptives are permitted.
- Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study product injection.
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- Not sterilized via bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, or, if menopausal, still menstruating or < 1 year of the last menses
- Women of childbearing potential must have used an acceptable form of contraception* in the 30 days prior to their first study product injection.
- Acceptable single forms of contraception include abstinence from sexual activity that could lead to pregnancy, monogamous relationship with vasectomized partner who has been vasectomized for six months or more prior to enrollment, successful Essure placement (permanent, non-surgical, non-hormonal sterilization), intrauterine devices, and hormonal methods, including the birth control patch, shot (Depo-Provera), pills, the vaginal ring (NuvaRing), and the contraceptive implant (Nexplanon). Acceptable barrier methods include diaphragm or cervical cap with spermicide and the contraceptive sponge.
- Women of childbearing potential must agree to continue use of an acceptable form of contraception through 30 days after their last study product injection.
- Weight >/= 50 kg and body mass index (BMI) < 35.0 kg/m2
- Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.*
- The normal protocol-defined ranges for vital signs include (a) oral temperature less than 38 degrees C (100.4 degrees F), (b) pulse no greater than 100 bpm, (c) systolic blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic BP </= 100 mmHg.
- Screening clinical lab values are all within normal protocol-defined reference ranges.
- The normal protocol-defined ranges for laboratory tests include (a) ALT of < 47 IU/L, (b) creatinine less than or equal to the laboratory upper limit of normal, (c) WBC >/=3.80 x10^3/UL and </=13.00 x10^3/UL, (d) hemoglobin 11.5 g/dL or greater for females or 12.6 g/dL or greater for males, (e) platelets between 131 x10^3/UL and 415 x10^3/UL, inclusive.
Who cannot join
- Has had known schistosomiasis infection or has traveled to an endemic area for schistosomiasis infection and, during that travel, was potentially exposed to a Schistosoma species.
- Has been treated for schistosomiasis.
- Has previous exposure to schistosome vaccines or experimental products containing GLA-SE.
- Female subjects who are breastfeeding a child ,or who plan to breastfeed a child from the first study product injection through 30 days after the last study product injection.
- Asthma, other than mild, well-controlled asthma*
- Cold or exercise-induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Subjects should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year
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- Known atherosclerotic cardiovascular disease or history of myocardial infarction, pericarditis, or myocarditis.
- Diabetes mellitus
- History of a psychiatric condition that may make study compliance difficult, such as schizophrenia, or poorly controlled bipolar disorder**
- Includes persons with psychoses or history of suicide attempt or gesture in the 3 years before study entry or an ongoing risk for suicide.
- Chronic or active neurologic condition (including seizures* and migraine headaches**).
- Seizure within the past 5 years
- Four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care.
- Autoimmune disease**
- autoimmune hypothyroidism with or without replacement therapy, and vitiligo or mild eczema or psoriasis not requiring chronic therapy, are permissible
- Known or suspected congenital or acquired immunodeficiency including anatomic or functional asplenia*** or immunosuppression as a result of underlying illness or treatment.
- Any splenectomy is exclusionary.
- Use of alcohol or drugs that, in the opinion of the investigator, may interfere with ability to comply with the protocol or increase risk to subject's health during the study period.
- Active neoplastic disease****
- Subjects with a history of malignancy may be included if treated by surgical excision, or by chemotherapy or radiation therapy and has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 36 months). Cervical neoplasia under surveillance and non-melanoma skin cancer are not exclusionary.
- Chronic topical or systemic corticosteroid use*****
- Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis prior to enrollment may be enrolled the day after their therapy is completed. Oral or parenteral (intravenous, IM, subcutaneous) corticosteroids given for non-chronic conditions not expected to recur are permissible if, within the year prior to enrollment, the longest course of therapy was no more than 14 days and no oral or parenteral corticosteroids were given within 30 days prior to enrollment. Intraarticular, bursal, tendon, or epidural injections of corticosteroids are permissible if the most recent injection was at least 30 days prior to enrollment. Topical or systemic corticosteroid use for study related AEs is not exclusionary.
- Known contraindication to repeated phlebotomy**
- Such as minimal venous access or recent history of anemia
- Receipt or planned receipt of inactivated vaccine or allergy desensitization injection within 14 days before or after a study product injection.
- Receipt or planned receipt of live attenuated vaccine within 28 days before or after a study product injection.
- Receipt of blood products or immunoglobulin within six months prior to, or donation of a unit of blood within two months prior to, the first study product injection.
- Receipt of any experimental agent*** within 30 days prior to screening or planned receipt prior to the last study visit-**.
- Vaccine, drug, biologic, device, blood product, or medication.
- Receipt of experimental COVID-19 related products are not necessarily exclusionary and will be evaluated on a case-by-case basis.
- Plan to undergo surgery (elective or otherwise) within six months after study enrollment.
- Plans to enroll in another interventional clinical trial**** at any time during the study period.
- Includes trials evaluating interventions such as a drug, biologic, or device.
- Positive confirmatory test for HIV infection.
- Positive serologic test for hepatitis B surface antigen (HBsAg).
- Positive confirmatory test for hepatitis C virus (HCV) infection.
- Acute febrile illness (oral temperature = 38°C) or other acute illness within three days prior to study product injection.*****
- Note for afebrile, acute illness only: If a subject is afebrile, his/her acute illness is nearly resolved with only minor residual symptoms remaining, and, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol, the subject may receive study product injection without further approval from the DMID Medical Officer.
- Not willing to avoid donating blood during the study.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
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.
Read the 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.
- Conditions
- Schistosomiasis
- Being tested
- Sm-p80, Sm-p80 + GLA-SE
- Keywords
- Dose-Escalation, Immunigenicity, Open-label, Phase I, Reactogenicity, Schistosomiasis, Vaccine
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sm-p80Biological
The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection.
Sm-p80 + GLA-SEBiological
Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. N=9 Receives: Biological: Sm-p80 |
| B | Experimental | 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9 Receives: Biological: Sm-p80 + GLA-SE |
| C | Experimental | 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. N=9. Receives: Biological: Sm-p80 + GLA-SE |
| D | Experimental | 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9. Receives: Biological: Sm-p80 + GLA-SE |
| E | Experimental | 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. N=9. Receives: Biological: Sm-p80 + GLA-SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
Secondary outcomes (2)
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose
Seroconversion was defined as a fourfold rise from baseline.
Measured: 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.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start23 May 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292391
- Sponsor's protocol ID
- 18-0018
- Other IDs
- 5UM1AI148373-03
- Status last verified
- 30 Oct 2024
- First submitted
- 3 Mar 2022
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jackson LA, Coler RN, Deye GA, Carter D, Gray SA, Pecor T, Davis J, Larsen SE, Posavad CM, Cox C, Watanabe A, Lundeen JS, Gill R, Kalyanasundaram A, Siddiqui AA. Safety and immunogenicity of the Sm-p80 GLA-SE schistosomiasis vaccine. NPJ Vaccines. 2025 Nov 24;10(1):247. doi: 10.1038/s41541-025-01261-3.
PubMed 41285840
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT05292391
- Acronym / sponsor ID
- 18-0018
- Conditions
- Schistosomiasis
- Keywords
- Dose-Escalation, Immunigenicity, Open-label, Phase I, Reactogenicity, Schistosomiasis, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 May 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Sm-p800.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. N=9 |
| B | Experimental | Biological: Sm-p80 + GLA-SE0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9 |
| C | Experimental | Biological: Sm-p80 + GLA-SE0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. N=9. |
| D | Experimental | Biological: Sm-p80 + GLA-SE0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9. |
| E | Experimental | Biological: Sm-p80 + GLA-SE0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. N=9. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of consent.
- Able and willing to participate for the duration of the study and able to understand and comply with planned study procedures.
- Able and willing to provide written (not proxy) informed consent.
- 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 Exclusion Criteria), vitamins, and contraceptives are permitted.
Key exclusion criteria (40 listed)
- Has had known schistosomiasis infection or has traveled to an endemic area for schistosomiasis infection and, during that travel, was potentially exposed to a Schistosoma species.
- Has been treated for schistosomiasis.
- Has previous exposure to schistosome vaccines or experimental products containing GLA-SE.
- Female subjects who are breastfeeding a child ,or who plan to breastfeed a child from the first study product injection through 30 days after the last study product injection.
- Asthma, other than mild, well-controlled asthma*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sm-p80The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection. | Biological | A |
| Sm-p80 + GLA-SECombination vaccine containing Sm-p80 antigen and GLA-SE adjuvant. | Biological | B, C, D, E |
Primary outcome
Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study
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
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
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.
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
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
Chemistry measurements collected include alanine aminotransferase (ALT) and creatinine. Labs were collected on vaccination days and 7 days and 28 days post each vaccination.
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each 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
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 Unsolicited Adverse Events (AEs) Within 28 Days Post Each 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
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 Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs)
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
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.
2 secondary outcomes
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose
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.
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41285840Jackson LA, Coler RN, Deye GA, Carter D, Gray SA, Pecor T, Davis J, Larsen SE, Posavad CM, Cox C, Watanabe A, Lundeen JS, Gill R, Kalyanasundaram A, Siddiqui AA. Safety and immunogenicity of the Sm-p80 GLA-SE schistosomiasis vaccine. NPJ Vaccines. 2025 Nov 24;10(1):247. doi: 10.1038/s41541-025-01261-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sm-p80 and Sm-p80 + GLA-SE in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.