- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03110757
A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults
A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Minas Gerais
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Novo Oriente, Minas Gerais, Brasilia
- Americaninhas Vaccine Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Provide written informed consent prior to any study procedures.
- Able to understand and comply with planned study procedures and be available for all study visits.
- Male or non-pregnant female aged 18 to 50, inclusive at the time of enrollment.
Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening.
-Existing medical diagnoses or conditions (except those in the Subject Exclusion Criteria) must be deemed as stable chronic medical conditions. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months (90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months (180 days). Any change due to change of health care provider, 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 principal investigator or appropriate sub-investigator, will not be considered a violation of this inclusion criterion. Subjects may be on chronic or as needed medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity. Topical, nasal, and inhaled medications (with the exception of corticosteroids as outlined in the Subjects Exclusion Criteria), vitamins, and contraceptives are permitted.
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 38.0 degrees celsius, (b) pulse 50 to 100 bpm, inclusive, (c) systolic blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic blood pressure 55 to 90 mmHg, inclusive. Pulse rate <50 is acceptable for 2nd and 3rd vaccinations if the subject is otherwise healthy with documented sinus bradycardia at baseline.
Laboratory tests (alanine aminotransferase, creatinine, white blood cell count, hemoglobin, and platelets) are all within protocol-defined reference ranges.
-The protocol-defined ranges for laboratory tests include (a) alanine aminotransferase (ALT) of less than 1.25-times the upper reference limit, (b) creatinine less than 1.25 times the upper reference limit (c) white blood cells (WBC) between 3.3 x10^3/uL and 10.4 x10^3/uL, inclusive, (d) hemoglobin 11.4 g/dL or greater for females or 12.1 g/dL or greater for males, (e) platelets greater than 130 x10^3/uL. Laboratory test results for 2nd and 3rd vaccinations may be at Grade 1 if considered unrelated to study product.
- Urinalysis with no greater than trace protein and negative for glucose.
Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to study product exposure and for 30 days after last vaccination.
- Female subjects who are surgically sterile via tubal sterilization, bilateral oophorectomy or hysterectomy or who have been postmenopausal for greater than 1 year are not considered to be of childbearing potential.
- Highly effective methods of contraception are defined as having low failure rates (i.e. less than 1% per year) when used consistently and correctly and may include, but are not limited to, abstinence from intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms or diaphragm with spermicide, intrauterine devices, and licensed hormonal methods.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
- Able to correctly answer all questions on the informed consent comprehension questionnaire.
Exclusion Criteria:
- Has the intention to become pregnant within 5 months after enrollment in this study.
- Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination.
- Has an acute illness, including a documented oral temperature of 38.0 degrees celsius or greater, within 72 hours prior to vaccination.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
Is immunosuppressed as a result of an underlying illness or treatment.
-Causes for immunosuppression may include, but are not limited to, poorly-controlled diabetes mellitus, cirrhosis, renal insufficiency, active neoplastic disease or a history of any hematologic malignancy, connective tissue disease, organ transplant.
- Using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Positive hepatitis B surface antigen (HBsAg)
- Positive confirmatory test for HIV infection
- Positive confirmatory test for hepatitis C virus (HCV) infection
- Volunteer has had a history of alcohol or illicit drug abuse during the past 24 months.
- Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
- History of a severe allergic reaction or anaphylaxis to known components of the study vaccines.
Has an acute or chronic medical condition that, in the opinion of the investigator, would render participation in this study unsafe or would interfere with the evaluation of responses.
-This includes, but is not limited to: known liver disease, renal disease, neurological disorders, visual field defects, cardiac disorders, pulmonary disorders, diabetes mellitus, and transplant recipients.
- History of splenectomy
Is participating or plans to participate in another clinical trial with an interventional agent during the duration of the study.
-This may include other licensed or unlicensed vaccines, drugs, biologics, devices, blood products, or medications.
- Received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to the first study vaccination.
- Planned receipt of any vaccine from the first study vaccination through 28 days after the last study vaccination.
- Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- 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.
- Anti-Sm-TSP-2 IgE antibody level above ELISA reactivity threshold.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Group A
10mcg Sm-TSP-2/Alhydrogel® (n=8)
|
Sm-TSP-2/Alhydrogel
|
Kokeellinen: Group B
10mcg Sm-TSP-2/Alhydrogel®/+ AP 10-701 (n=8)
|
Sm-TSP-2/Alhydrogel
Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF).
It is a toll-like receptor-4 agonist
|
Kokeellinen: Group D
30mcg Sm-TSP-2/Alhydrogel® (n=8)
|
Sm-TSP-2/Alhydrogel
|
Kokeellinen: Group E
30mcg Sm-TSP-2/Alhydrogel®/+ AP 10-701 (n=8)
|
Sm-TSP-2/Alhydrogel
Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF).
It is a toll-like receptor-4 agonist
|
Kokeellinen: Group G
100mcg Sm-TSP-2/Alhydrogel® (n=8)
|
Sm-TSP-2/Alhydrogel
|
Kokeellinen: Group H
100mcg Sm-TSP-2/Alhydrogel®/+ AP 10-701 (n=8)
|
Sm-TSP-2/Alhydrogel
Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF).
It is a toll-like receptor-4 agonist
|
Active Comparator: Pooled Active Comparator Group
Euvax B Hepatitis B vaccine (n=12)
|
A non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
The occurrence of new-onset chronic medical conditions (including AESI)
Aikaikkuna: From Day 1 to Day 478
|
From Day 1 to Day 478
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The occurrence of solicited injection site reactogenicity
Aikaikkuna: From Day 1 to Day 7
|
From Day 1 to Day 7
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The occurrence of solicited injection site reactogenicity
Aikaikkuna: From Day 113 to Day 120
|
From Day 113 to Day 120
|
The occurrence of solicited injection site reactogenicity
Aikaikkuna: From Day 57 to Day 64
|
From Day 57 to Day 64
|
The occurrence of solicited systemic reactogenicity
Aikaikkuna: From Day 1 to Day 7
|
From Day 1 to Day 7
|
The occurrence of solicited systemic reactogenicity
Aikaikkuna: From Day 113 to Day 120
|
From Day 113 to Day 120
|
The occurrence of solicited systemic reactogenicity
Aikaikkuna: From Day 57 to Day 64
|
From Day 57 to Day 64
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The occurrence of study vaccine-related SAEs
Aikaikkuna: From Day 1 to Day 478
|
From Day 1 to Day 478
|
The occurrence of vaccine-related clinical safety laboratory adverse events
Aikaikkuna: Day 113
|
Day 113
|
The occurrence of vaccine-related clinical safety laboratory adverse events
Aikaikkuna: Day 120
|
Day 120
|
The occurrence of vaccine-related clinical safety laboratory adverse events
Aikaikkuna: Day 57
|
Day 57
|
The occurrence of vaccine-related clinical safety laboratory adverse events
Aikaikkuna: Day 64
|
Day 64
|
The occurrence of vaccine-related clinical safety laboratory adverse events
Aikaikkuna: Day 8
|
Day 8
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA
Aikaikkuna: Day 15
|
Day 15
|
The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA
Aikaikkuna: Day 203
|
Day 203
|
The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA
Aikaikkuna: Day 293
|
Day 293
|
The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA
Aikaikkuna: Day 478
|
Day 478
|
The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA
Aikaikkuna: Day 71
|
Day 71
|
The anti-Sm-TSP-2 IgG level using an indirect ELISA
Aikaikkuna: Day 127
|
Day 127
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Infektiot
- Vektorivälitteiset sairaudet
- Parasiittiset sairaudet
- Helmintiaasi
- Trematodi-infektiot
- Skistosomiaasi
- Mansoni skistosomiaasi
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Immunologiset tekijät
- Ruoansulatuskanavan aineet
- Adjuvantit, immunologiset
- Antasidit
- Alumiinihydroksidi
Muut tutkimustunnusnumerot
- 14-0100
- HHSN272201300015I
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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