Hookworm Infections
Conditions
Keywords
Controlled infection, Na-GST-1, Hookworm vaccine
Brief summary
This study evaluates the efficacy, safety and immunogenicity of different formulations of the Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy, hookworm-naive adults.
Detailed description
Double blind, randomized, controlled, Phase 2 clinical trial in hookworm-unexposed adults living in the metropolitan area of Washington, DC. Subjects will receive three doses of the assigned vaccine formulation, or saline placebo, delivered intramuscularly on approximately Days 0, 56, and 112. Subjects will be challenged with 50 infectious N. americanus larvae 4 weeks after 3rd vaccination. Fecal samples will be collected weekly starting 4 weeks post-challenge. Albendazole will be administered 20 weeks post-challenge to cure infections. Subjects will be followed until 10 months after their final vaccination. Safety of vaccination will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events. Safety of CHHI will be measure from the time of larval application (Day 140) through the first day of treatment with albendazole (Day 280). Unsolicited non-serious adverse events (AEs) will be collected until approximately 1 month following each study vaccination and from study Day 140 (day of CHHI) through Day 280. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 10 months after the third study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination and CHHI. Immunogenicity testing will include IgG antibody responses to Na-GST-1, by a qualified indirect enzyme-linked immunosorbent assay (ELISA), on serum obtained prior to each study vaccination and CHHI, and at time points after each vaccination and after CHHI (see Appendix A); the affinity of vaccine-induced antibodies against Na-GST-1 using Surface Plasmon Resonance; the functional activity of vaccine-induced antibodies via in vitro enzyme neutralization assay; antigen-specific memory B cell responses; and, the innate immune responses to each of the TLR receptor immunostimulants. Parasitological testing will include microscopic fecal egg detection by a qualified saline flotation technique, fecal egg counts by the McMaster method, fecal PCR for hookworm DNA, and peripheral eosinophil counts. Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence. 48 subjects will be enrolled into 4 groups of 12. Subjects will be enrolled sequentially and upon enrollment will be randomized to one of the following IP assignments in a double-blind fashion: * Group 1 IP allocation (n=12 subjects): 12 subjects will receive 100µg Na-GST-1/Alhydrogel® delivered by IM injection in the deltoid muscle. * Group 2 IP allocation (n=12): 12 subjects will receive Na-GST-1/Alhydrogel® plus 500µg CpG 10104 delivered by IM injection in the deltoid muscle. * Group 3 IP allocation (n=12): 12 subjects will receive Na-GST-1/Alhydrogel® plus 5µg GLA-AF delivered by IM injection in the deltoid muscle. * Group 4 IP allocation (n=12): 12 subjects will receive sterile saline delivered by IM injection in the deltoid muscle.
Interventions
BIOLOGICALNa-GST-1/Alhydrogel
Recombinant Necator americanus Glutathione-S Transferase adjuvanted with Alhydrogel
BIOLOGICALNa-GST-1/Alhydrogel + CPG 10104
Recombinant Necator americanus Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with CPG 10104, a synthetic oligodeoxynucleotide
BIOLOGICALNa-GST-1/Alhydrogel + GLA-AF
Recombinant Necator americanus Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl-Lipid A (GLA-AF)
BIOLOGICALPlacebo
Physiological sterile saline solution
DRUGAlbendazole
Treatment with 3 daily oral doses of 400 mg albendazole at end of study.
OTHERNecator americanus Larval Inoculum
50 infectious Necator americanus larvae applied via dermal application (challenge infection).
Sponsors
Baylor College of Medicine
George Washington University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants and investigators will be blinded to study product allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and non-pregnant females between 18 and 45 years, inclusive. 2. Good general health as determined by means of the screening procedures1. 3. Available for the duration of individual subject study participation (14 months). 4. Willingness to participate in the study as evidenced by signing the informed consent document. 5. Able to understand and comply with planned study procedures.
Exclusion criteria
1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female). 2. Subject unwilling to use effective contraception for a minimum of 30 days prior to vaccination and up until documentation of clearance of hookworm infection post-CHHI (if female and not surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile). 3. Currently lactating and breast-feeding or plans to breastfeed at any given time from the first study vaccination until clearance of hookworm infection post-CHHI (if female). 4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, gastrointestinal, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 5. Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide). 6. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment (causes for immunosuppression may include, but are not limited to, poorly-controlled diabetes mellitus, chronic liver disease, renal insufficiency, active neoplastic disease or a history of hematologic malignancy, connective tissue disease, organ transplant). 7. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit). 8. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or urine dipstick testing positive for glucose or more than trace protein). 9. Laboratory evidence of hematologic disease (hemoglobin \<11.1 g/dl \[females\] or \<12.5 g/dl \[males\]; absolute leukocyte count \<3400/mm3 or \>10.8 x 103/mm3; absolute eosinophil count \<500/mm3; or platelet count \<140,000/mm3). 10. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. 11. Planned participation in another investigational vaccine or drug trial within 30 days of starting this study or until the last study visit (this may include other licensed or unlicensed vaccines, drugs, biologics, devices, blood products, or medications). 12. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months. 13. Positive fecal occult blood test at screening. 14. Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites at screening. 15. History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit). 16. History of hypoalbuminemia. 17. History of a severe allergic reaction or anaphylaxis. 18. Severe asthma as defined by the need for daily use of inhalers, or emergency clinic visit or hospitalization within 6 months of the volunteer's expected first vaccination in the study. 19. Positive test for hepatitis B surface antigen (HBsAg). 20. Positive confirmatory test for HIV infection. 21. Positive confirmatory test for hepatitis C virus (HCV) infection. 22. Using or intends to continue using oral or parenteral corticosteroids, high-dose inhaled corticosteroids (\>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days of the volunteer's expected first vaccination in this study or planned use during the study. 23. Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected first vaccination in the study. 24. Receipt of immunoglobin or other blood products (with exception of Rho D immunoglobulin) within 90 days of the planned first study vaccination. 25. Known allergy to albendazole, amphotericin B or gentamicin. 26. History of previous infection with hookworm or continuous residence for more than 6 months in a community where hookworm is endemic. 27. Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application. 28. Previous receipt of the Na-GST-1/Alhydrogel® hookworm vaccine. 29. History of a surgical splenectomy. 30. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia; or laboratory evidence of possible autoimmune disease determined by a positive anti-dsDNA titer, positive rheumatoid factor, and/or proteinuria (greater than trace protein on urine dipstick testing).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detectable Hookworm Infection | On Study Days 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280. | Proportion of subjects with detectable hookworm eggs, at any time point, in fecal samples, as determined by microscopy using the qualified saline flotation technique |
| Incidence of Serious Adverse Events | Beginning on Day 0 when the first dose is received and ending on Day 380 (final study visit). | Frequency of study vaccine-related Serious Adverse Events from the time of the first study vaccination through approximately 10 months after the last study vaccination. |
| Incidence of Solicited Injection Site and Systemic Reactogenicity | Dose 1: Days 0, 3, 7, 14; Dose 2: Days 56, 59, 63, 70; Dose 3: Days 112, 115, 119, 126 | Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination. |
| Incidence of Solicited Adverse Events | Day of CHHI, Day 140, and study days: 143, 147, 154, 175, 182, 189, 196, 203, 210, 217, 224, 231, 238, 245, 252, 259, 266, 273, 280. Day 280 is the day of anti-worm treatment. | Frequency of solicited adverse events, graded by severity, on the day of CHHI through study Day 280 |
| Incidence of Clinical Safety Laboratory Abnormalities | Study days: 0, 14, 56, 70, 112, 126, 140, 154, 175, 189, 203, 217, 231, 259, 280. | Frequency of clinical safety laboratory adverse events. |
| Incidence of Unsolicited Adverse Events | From Dose 1 on Day 0 until anti-worm treatment on Day 280. | Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination; and from the time of CHHI through treatment with albendazole (Day 280) |
| Incidence of New-onset Chronic Medical Conditions | Entire duration of the study. Beginning Day 0, day of first dose, until Day 380, final study visit. | Frequency of new-onset chronic medical conditions through approximately 10 months after the third study vaccination. |
| Incidence of Adverse Events of Special Interest | Entire duration of the study. Beginning Day 0, day of first dose, until Day 380, final study visit. | Frequency of Adverse Events of Special Interest through approximately 10 months after the third study vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Egg Counts | Week 5 and Week 20 post-CHHI. Study days: 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280. | Fecal egg counts as determined by microscopy using the McMaster method, weekly from Weeks 5 through 20 post-CHHI |
| Anti-Na-GST-1 IgG Antibody Response | Study days: 14, 70, 126, 140, 175, 189, 231, 280, 320, and 380 | Anti-Na-GST-1 IgG antibody response as measured in Arbitrary Units per milliliter (AU/mL) of serum, determined by a qualified indirect enzyme-linked immunosorbent assay (ELISA) at approximately 14 days after each vaccination, and approximately 1, 2, 4, 6, 7, 8 and 10 months after the third dose. Levels of IgG antibodies against Na-GST-1 were converted to AUs by homologous interpolation of Optical Density readings at 492nm (OD492) from a standard calibration curve derived from serial dilutions of a human standard reference serum pool collected from high IgG responders (OD492 ≥ 1.000). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Diemert, MD
George Washington University
Participant flow
Recruitment details
Recruitment and enrollment occurred on an ongoing basis, with each group being recruited and vaccinated in parallel. Participants were enrolled sequentially and upon enrollment were randomized to one of the four groups.
Participants by arm
| Arm | Count |
|---|---|
| Na-GST-1/Alhydrogel 100 µg Na-GST-1/Alhydrogel administered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140. | 10 |
| Na-GST-1/Alhydrogel + CPG 10104 100 µg Na-GST-1/Alhydrogel co-administered with 500 µg CPG 10104 delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140. | 9 |
| Na-GST-1/Alhydrogel + GLA-AF 100 µg Na-GST-1/Alhydrogel co-administered with 5 µg GLA-AF delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140. | 10 |
| Saline Placebo Sterile saline placebo delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140. | 10 |
| Total | 39 |
Baseline characteristics
| Characteristic | Na-GST-1/Alhydrogel | Na-GST-1/Alhydrogel + CPG 10104 | Na-GST-1/Alhydrogel + GLA-AF | Saline Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 26.1 Years STANDARD_DEVIATION 4.6 | 30.4 Years STANDARD_DEVIATION 8.2 | 24.7 Years STANDARD_DEVIATION 3.3 | 26.1 Years STANDARD_DEVIATION 3.45 | 26.7 Years STANDARD_DEVIATION 5.4 |
| Age, Customized Age, Continuous | 25.5 Years | 29.0 Years | 23.5 Years | 25.5 Years | 26.0 Years |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 9 Participants | 6 Participants | 9 Participants | 8 Participants | 32 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 8 Participants | 5 Participants | 6 Participants | 6 Participants | 25 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 6 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 4 Participants | 3 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 10 / 10 | 9 / 9 | 10 / 10 | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 | 1 / 9 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Detectable Hookworm Infection
Proportion of subjects with detectable hookworm eggs, at any time point, in fecal samples, as determined by microscopy using the qualified saline flotation technique
Time frame: On Study Days 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280.
Population: The number of participants analyzed each week varies due to participants missing that visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 231 | 4 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 245 | 3 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 273 | 2 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 259 | 2 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 203 | 4 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 182 | 0 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 189 | 0 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 217 | 3 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 280 | 3 Participants |
| Group 1: Na-GST-1/Alhydrogel | Detectable Hookworm Infection | Day 175 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 273 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 231 | 1 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 280 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 175 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 182 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 245 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 217 | 1 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 189 | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 203 | 1 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Detectable Hookworm Infection | Day 259 | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 182 | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 273 | 6 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 280 | 5 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 189 | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 203 | 3 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 259 | 4 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 217 | 4 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 231 | 6 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 245 | 5 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Detectable Hookworm Infection | Day 175 | 0 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 280 | 3 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 182 | 1 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 189 | 2 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 203 | 2 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 217 | 4 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 231 | 4 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 245 | 3 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 259 | 4 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 273 | 3 Participants |
| Group 4: Saline Placebo | Detectable Hookworm Infection | Day 175 | 0 Participants |
Primary
Incidence of Adverse Events of Special Interest
Frequency of Adverse Events of Special Interest through approximately 10 months after the third study vaccination.
Time frame: Entire duration of the study. Beginning Day 0, day of first dose, until Day 380, final study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Adverse Events of Special Interest | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Adverse Events of Special Interest | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Adverse Events of Special Interest | 0 Participants |
| Group 4: Saline Placebo | Incidence of Adverse Events of Special Interest | 0 Participants |
Primary
Incidence of Clinical Safety Laboratory Abnormalities
Frequency of clinical safety laboratory adverse events.
Time frame: Study days: 0, 14, 56, 70, 112, 126, 140, 154, 175, 189, 203, 217, 231, 259, 280.
Population: 39 participants received at least 1 study vaccination and 33 participants received the CHHI.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during Vaccination Phase | 1 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during CHHI Phase | 7 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during CHHI Phase | 3 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during Vaccination Phase | 3 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during Vaccination Phase | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during CHHI Phase | 9 Participants |
| Group 4: Saline Placebo | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during Vaccination Phase | 2 Participants |
| Group 4: Saline Placebo | Incidence of Clinical Safety Laboratory Abnormalities | Number of Participants reporting Clinical Laboratory Adverse Event during CHHI Phase | 7 Participants |
Primary
Incidence of New-onset Chronic Medical Conditions
Frequency of new-onset chronic medical conditions through approximately 10 months after the third study vaccination.
Time frame: Entire duration of the study. Beginning Day 0, day of first dose, until Day 380, final study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of New-onset Chronic Medical Conditions | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of New-onset Chronic Medical Conditions | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of New-onset Chronic Medical Conditions | 0 Participants |
| Group 4: Saline Placebo | Incidence of New-onset Chronic Medical Conditions | 0 Participants |
Primary
Incidence of Serious Adverse Events
Frequency of study vaccine-related Serious Adverse Events from the time of the first study vaccination through approximately 10 months after the last study vaccination.
Time frame: Beginning on Day 0 when the first dose is received and ending on Day 380 (final study visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Serious Adverse Events | 0 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Serious Adverse Events | 0 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Serious Adverse Events | 0 Participants |
| Group 4: Saline Placebo | Incidence of Serious Adverse Events | 0 Participants |
Primary
Incidence of Solicited Adverse Events
Frequency of solicited adverse events, graded by severity, on the day of CHHI through study Day 280
Time frame: Day of CHHI, Day 140, and study days: 143, 147, 154, 175, 182, 189, 196, 203, 210, 217, 224, 231, 238, 245, 252, 259, 266, 273, 280. Day 280 is the day of anti-worm treatment.
Population: Number of participants reporting solicited adverse events during CHHI phase of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Solicited Adverse Events | 8 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Solicited Adverse Events | 5 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Solicited Adverse Events | 10 Participants |
| Group 4: Saline Placebo | Incidence of Solicited Adverse Events | 9 Participants |
Primary
Incidence of Solicited Injection Site and Systemic Reactogenicity
Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination.
Time frame: Dose 1: Days 0, 3, 7, 14; Dose 2: Days 56, 59, 63, 70; Dose 3: Days 112, 115, 119, 126
Population: 39 participants received the first dose of the study product, 37 participants received the second dose of the study product, and 36 participants received the third and final dose of the study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #1 | 10 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #3 | 8 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #2 | 9 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #1 | 9 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #3 | 7 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #2 | 7 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #2 | 9 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #1 | 10 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #3 | 9 Participants |
| Group 4: Saline Placebo | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #1 | 7 Participants |
| Group 4: Saline Placebo | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #3 | 7 Participants |
| Group 4: Saline Placebo | Incidence of Solicited Injection Site and Systemic Reactogenicity | Number of Participants Reporting Solicited Adverse Events Post Dose #2 | 5 Participants |
Primary
Incidence of Unsolicited Adverse Events
Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination; and from the time of CHHI through treatment with albendazole (Day 280)
Time frame: From Dose 1 on Day 0 until anti-worm treatment on Day 280.
Population: 39 participants received Dose #1, 37 participants received Dose #2, 36 participants received Dose #3, and 33 participants received the CHHI.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #1 | 5 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #2 | 3 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #3 | 6 Participants |
| Group 1: Na-GST-1/Alhydrogel | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs post-CHHI | 9 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #2 | 5 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #3 | 4 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs post-CHHI | 5 Participants |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #1 | 6 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #3 | 5 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #2 | 6 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs post-CHHI | 10 Participants |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #1 | 4 Participants |
| Group 4: Saline Placebo | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs post-CHHI | 9 Participants |
| Group 4: Saline Placebo | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #2 | 6 Participants |
| Group 4: Saline Placebo | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #1 | 8 Participants |
| Group 4: Saline Placebo | Incidence of Unsolicited Adverse Events | Participants Reporting Unsolicited AEs up to 28 Days After Dose #3 | 7 Participants |
Secondary
Anti-Na-GST-1 IgG Antibody Response
Anti-Na-GST-1 IgG antibody response as measured in Arbitrary Units per milliliter (AU/mL) of serum, determined by a qualified indirect enzyme-linked immunosorbent assay (ELISA) at approximately 14 days after each vaccination, and approximately 1, 2, 4, 6, 7, 8 and 10 months after the third dose. Levels of IgG antibodies against Na-GST-1 were converted to AUs by homologous interpolation of Optical Density readings at 492nm (OD492) from a standard calibration curve derived from serial dilutions of a human standard reference serum pool collected from high IgG responders (OD492 ≥ 1.000).
Time frame: Study days: 14, 70, 126, 140, 175, 189, 231, 280, 320, and 380
Population: The number of participants analyzed each week varies due to participants missing that visits and/or that visit occurring too far out of window. Additionally, 39 participants received Dose 1, 37 participants received Dose 2, 36 participants received Dose 3, and 33 participants received the CHHI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 14 | 1.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 0.9 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 70 (14 days post Dose 2) | 5.6 Arbitrary Units (AUs) per milliliter | Standard Deviation 1.1 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 126 (14 days post Dose 3) | 21.1 Arbitrary Units (AUs) per milliliter | Standard Deviation 32.4 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 140 (1 month post Dose 3) | 8.5 Arbitrary Units (AUs) per milliliter | Standard Deviation 5.1 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 175 (2 months post Dose 3) | 6.9 Arbitrary Units (AUs) per milliliter | Standard Deviation 5.2 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 189 (4 months post Dose 3) | 7.1 Arbitrary Units (AUs) per milliliter | Standard Deviation 5.8 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 231 (6 months post Dose 3) | 6.3 Arbitrary Units (AUs) per milliliter | Standard Deviation 4.4 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 280 (7 months post Dose 3) | 4.5 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.9 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 320 (8 months post Dose 3) | 4.6 Arbitrary Units (AUs) per milliliter | Standard Deviation 3 |
| Group 1: Na-GST-1/Alhydrogel | Anti-Na-GST-1 IgG Antibody Response | Day 380 (10 months post Dose 3) | 3.9 Arbitrary Units (AUs) per milliliter | Standard Deviation 3.4 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 126 (14 days post Dose 3) | 55.3 Arbitrary Units (AUs) per milliliter | Standard Deviation 65.4 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 320 (8 months post Dose 3) | 22.8 Arbitrary Units (AUs) per milliliter | Standard Deviation 35.8 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 140 (1 month post Dose 3) | 31.0 Arbitrary Units (AUs) per milliliter | Standard Deviation 29.5 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 175 (2 months post Dose 3) | 42.6 Arbitrary Units (AUs) per milliliter | Standard Deviation 72.1 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 189 (4 months post Dose 3) | 26.3 Arbitrary Units (AUs) per milliliter | Standard Deviation 28.4 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 231 (6 months post Dose 3) | 35.1 Arbitrary Units (AUs) per milliliter | Standard Deviation 53.3 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 380 (10 months post Dose 3) | 110 Arbitrary Units (AUs) per milliliter | Standard Deviation 11.6 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 280 (7 months post Dose 3) | 21.6 Arbitrary Units (AUs) per milliliter | Standard Deviation 26.7 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 14 | 1.4 Arbitrary Units (AUs) per milliliter | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Anti-Na-GST-1 IgG Antibody Response | Day 70 (14 days post Dose 2) | 34.8 Arbitrary Units (AUs) per milliliter | Standard Deviation 30.9 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 280 (7 months post Dose 3) | 4.0 Arbitrary Units (AUs) per milliliter | Standard Deviation 3.8 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 231 (6 months post Dose 3) | 5.2 Arbitrary Units (AUs) per milliliter | Standard Deviation 5.8 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 380 (10 months post Dose 3) | 3.1 Arbitrary Units (AUs) per milliliter | Standard Deviation 3.4 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 14 | 1.4 Arbitrary Units (AUs) per milliliter | Standard Deviation 0 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 140 (1 month post Dose 3) | 10.9 Arbitrary Units (AUs) per milliliter | Standard Deviation 12.7 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 189 (4 months post Dose 3) | 6.2 Arbitrary Units (AUs) per milliliter | Standard Deviation 6.6 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 320 (8 months post Dose 3) | 3.8 Arbitrary Units (AUs) per milliliter | Standard Deviation 3.1 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 70 (14 days post Dose 2) | 26.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 65.5 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 175 (2 months post Dose 3) | 7.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 7.9 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Anti-Na-GST-1 IgG Antibody Response | Day 126 (14 days post Dose 3) | 18.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 23.3 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 175 (2 months post Dose 3) | 1.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 1 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 280 (7 months post Dose 3) | 2.4 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.6 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 189 (4 months post Dose 3) | 2.2 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.3 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 380 (10 months post Dose 3) | 2.3 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.3 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 231 (6 months post Dose 3) | 2.3 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.6 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 70 (14 days post Dose 2) | 2.0 Arbitrary Units (AUs) per milliliter | Standard Deviation 1.8 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 126 (14 days post Dose 3) | 1.4 Arbitrary Units (AUs) per milliliter | Standard Deviation 0 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 140 (1 month post Dose 3) | 2.2 Arbitrary Units (AUs) per milliliter | Standard Deviation 2.3 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 14 | 1.7 Arbitrary Units (AUs) per milliliter | Standard Deviation 1 |
| Group 4: Saline Placebo | Anti-Na-GST-1 IgG Antibody Response | Day 320 (8 months post Dose 3) | 2.6 Arbitrary Units (AUs) per milliliter | Standard Deviation 3.3 |
Secondary
Fecal Egg Counts
Fecal egg counts as determined by microscopy using the McMaster method, weekly from Weeks 5 through 20 post-CHHI
Time frame: Week 5 and Week 20 post-CHHI. Study days: 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280.
Population: The number of participants analyzed each week varies due to participants missing that visits and/or that visit occurring too far out of window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 6 post-CHHI (Day 182) | 0.0 Eggs | Standard Deviation 0 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 14 post-CHHI (Day 245) | 16.7 Eggs | Standard Deviation 34.5 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 18 post-CHHI (Day 273) | 16.7 Eggs | Standard Deviation 35.6 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 12 post-CHHI (Day 231) | 14.8 Eggs | Standard Deviation 19.4 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 16 post-CHHI (Day 259) | 31.5 Eggs | Standard Deviation 72.9 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 9 post-CHHI (Day 203) | 11.1 Eggs | Standard Deviation 16.7 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 5 post-CHHI (Day 175) | 0.0 Eggs | Standard Deviation 0 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 7 post-CHHI (Day 189) | 0.0 Eggs | Standard Deviation 0 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 10 post-CHHI (Day 217) | 7.4 Eggs | Standard Deviation 12.1 |
| Group 1: Na-GST-1/Alhydrogel | Fecal Egg Counts | Week 20 post-CHHI (Day 280) | 13.0 Eggs | Standard Deviation 23.2 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 7 post-CHHI (Day 189) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 12 post-CHHI (Day 231) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 20 post-CHHI (Day 280) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 6 post-CHHI (Day 182) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 18 post-CHHI (Day 273) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 14 post-CHHI (Day 245) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 5 post-CHHI (Day 175) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 10 post-CHHI (Day 217) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 9 post-CHHI (Day 203) | 0.0 Eggs | Standard Deviation 0 |
| Group 2: Na-GST-1/Alhydrogel + CPG 10104 | Fecal Egg Counts | Week 16 post-CHHI (Day 259) | 0.0 Eggs | Standard Deviation 0 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 9 post-CHHI (Day 203) | 5.6 Eggs | Standard Deviation 11.8 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 18 post-CHHI (Day 273) | 33.3 Eggs | Standard Deviation 43.7 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 20 post-CHHI (Day 280) | 35.4 Eggs | Standard Deviation 52.3 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 7 post-CHHI (Day 189) | 0.0 Eggs | Standard Deviation 0 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 16 post-CHHI (Day 259) | 59.3 Eggs | Standard Deviation 89.8 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 5 post-CHHI (Day 175) | 0.0 Eggs | Standard Deviation 0 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 10 post-CHHI (Day 217) | 22.9 Eggs | Standard Deviation 41.7 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 12 post-CHHI (Day 231) | 48.3 Eggs | Standard Deviation 88.7 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 14 post-CHHI (Day 245) | 35.0 Eggs | Standard Deviation 50 |
| Group 3: Na-GST-1/Alhydrogel + GLA-AF | Fecal Egg Counts | Week 6 post-CHHI (Day 182) | 0.0 Eggs | Standard Deviation 0 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 20 post-CHHI (Day 280) | 16.7 Eggs | Standard Deviation 23.6 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 5 post-CHHI (Day 175) | 0.0 Eggs | Standard Deviation 0 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 6 post-CHHI (Day 182) | 4.2 Eggs | Standard Deviation 11.8 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 7 post-CHHI (Day 189) | 10.4 Eggs | Standard Deviation 23.5 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 9 post-CHHI (Day 203) | 31.0 Eggs | Standard Deviation 58.1 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 10 post-CHHI (Day 217) | 38.9 Eggs | Standard Deviation 62.9 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 12 post-CHHI (Day 231) | 29.6 Eggs | Standard Deviation 58.8 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 14 post-CHHI (Day 245) | 14.6 Eggs | Standard Deviation 30.1 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 16 post-CHHI (Day 259) | 31.0 Eggs | Standard Deviation 29.5 |
| Group 4: Saline Placebo | Fecal Egg Counts | Week 18 post-CHHI (Day 273) | 38.1 Eggs | Standard Deviation 48.8 |