- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02364596
Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
A Phase 1, Single-arm, Open-label Study To Confirm The Safety, Tolerability, And Immunogenicity Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
-
-
Florida
-
Hollywood, Florida, Spojené státy, 33024
- Broward Research Group
-
South Miami, Florida, Spojené státy, 33143
- Miami Research Associates
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including daily completion of the e-diary for 10 days after study vaccination. 3. Healthy male and female subjects, aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included. 4. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. 5. Subject must be able to be contacted by telephone during study participation.
Exclusion Criteria: 1. Unstable chronic medical condition or disease requiring significant change in therapya or hospitalization for worsening disease within 3 months before receipt of investigational product. 2. Serious chronic medical disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study. 3. Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment or the use of systemic corticosteroids (equivalent of ≥10 mg/day of prednisone) for >14 days within 30 days prior to study enrollment. 4. History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant. 5. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment. 6. Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination. 7. Previous administration of S. aureus vaccine or S. aureus/Candida vaccine. 8. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. 9. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 10. Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection) or donation of plasma within 3 months prior to enrollment through conclusion of the study. 11. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months before enrollment or anticipated through conclusion of the subject's participation. 12. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. 13. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Participation in observational studies is permitted. 14. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential and at risk for pregnancy who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study. 15. Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care. An ambulatory subject who is a resident of a retirement home or village is eligible for the trial. 16. Subjects with known active disease with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 1
SA4Ag vaccine
|
Krev na imunogenicitu bude odebrána všem subjektům v různých časových bodech.
Subjects receive 1 intramuscular injection (0.5 mL) of the SA4Ag vaccine.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of subjects reporting local reactions (redness, swelling, and pain at the injection site) as self-reported on electronic diaries (e-diaries) for 10 days after vaccination.
Časové okno: 10 days
|
10 days
|
|
Number of subjects reporting systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle pain, and joint pain) as self-reported on e-diaries for 10 days after vaccination.
Časové okno: 10 days
|
10 days
|
|
Number of subjects reporting adverse events (AEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
Časové okno: 1 month
|
1 month
|
|
Number of subjects reporting serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
Časové okno: 1 month
|
1 month
|
|
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates
Časové okno: 1 month
|
1 month
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Competitive Luminex immunoassay titers summarized as geometric mean titers for S. aureus antigens
Časové okno: 1 month
|
1 month
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B3451015
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Stafylokokové infekce
-
University of KentuckyPfizerDokončenoMethicilin-rezistentní Staphylococcal Aureus pneumonieSpojené státy
-
Kevin WinthropAN2 Therapeutics, IncNáborInfekce Mycobacterium AbscessusSpojené státy
-
Beijing Chest HospitalZápis na pozvánkuInfekce Mycobacterium Abscessus | MonoterapieČína
-
Beijing Chest HospitalZápis na pozvánkuInfekce Mycobacterium Abscessus | NTM plicní infekce způsobená MACČína
-
Institute of Tropical Medicine, BelgiumDamien FoundationDokončeno
-
London School of Hygiene and Tropical MedicineArmauer Hansen Research Institute, Ethiopia; Alert Hospital, Ethiopia; Homes...Dokončeno
-
National Institute of Allergy and Infectious Diseases...DokončenoMalomocenství
-
The Immunobiological Technology Institute (Bio-Manguinhos)...Oswaldo Cruz InstituteZatím nenabírámeMalomocenstvíBrazílie
-
Institute of Tropical Medicine, BelgiumLeiden University Medical Center; Damien Foundation; Instituto Fernandes Figueira a další spolupracovníciDokončenoMalomocenstvíKomory, Madagaskar
Klinické studie na Krevní vzorek
-
Hillel Yaffe Medical CenterNeznámý
-
National Marrow Donor ProgramDokončenoLymfom | Myelodysplastické syndromy | LeukémieSpojené státy
-
Careggi HospitalUniversity of FlorenceNáborSepse | Syndrom systémové zánětlivé odpovědi | Závažné onemocnění | Akutní poškození ledvinItálie
-
Assistance Publique - Hôpitaux de ParisFilière des Maladies Rares Abdomino-THOraciques : FIMATHO; URC-CIC Paris Descartes...StaženoVrozená brániční kýla | Gastroschíza | OmfalokélaFrancie
-
ExThera Medical Europe BVExThera Medical Corporation; Vivantes Clinic NeuköllnNáborInfekce krevního řečištěFrancie, Německo, Holandsko, Rakousko, Belgie, Itálie, Polsko, Španělsko, Spojené království
-
Guardant Health, Inc.Nábor
-
University Hospital, RouenNáborŽloutenka typu B | Hepatitida C | AIDSFrancie
-
Kirby InstituteDokončenoŽloutenka typu BAustrálie
-
Bursa Uludag UniversitesiZápis na pozvánkuRakovina tlustého střeva | Chemoterapeutický efekt | Orální mukositida | Role sestryKrocan