Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults

NCT05292391 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18-00185UM1AI148373-03
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Keywords

Dose-Escalation; Immunigenicity; Open-label; Phase I; Reactogenicity; Schistosomiasis; Vaccine

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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.

  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.

  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).

  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.

  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

  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

  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.

Study Arms (5)

A

EXPERIMENTAL

0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. N=9

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

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.

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.

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.

Biological: Sm-p80 + GLA-SE

Interventions

Sm-p80 BIOLOGICAL

The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection.

A

Sm-p80 + GLA-SE BIOLOGICAL

Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.

B; C; D; E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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\*.

You may not qualify if:

• 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.
• \*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.
• 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\*

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101-1466, United States

Location

Related Publications (1)

• 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.

  PMID: 41285840 DERIVED

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Results Point of Contact

• Title: Lisa A. Jackson, MD, MPH
• Organization: Kaiser Permanente Washington Health Research Institute

Lisa.A.Jackson@kp.org

(206)-442-5216

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 23, 2022
• Study Start: May 23, 2022
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: July 14, 2025
• Results First Posted: April 11, 2025

Record last verified: 2024-10-30

Locations

US (1)