- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02926430
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
18 febbraio 2019 aggiornato da: Janssen Vaccines & Prevention B.V.
A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF,
administered intramuscularly to elderly adults given approximately 12 months apart.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
73
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Florida
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Miami, Florida, Stati Uniti
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
60 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion Criteria:
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Altri nomi:
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Sperimentale: Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Altri nomi:
Participants will receive placebo as formulation buffer.
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Sperimentale: Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Altri nomi:
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Sperimentale: Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Altri nomi:
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Sperimentale: Placebo (Day 1 and Day 365): Group 5
Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Lasso di tempo: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Lasso di tempo: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Lasso di tempo: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Lasso di tempo: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Lasso di tempo: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Lasso di tempo: Up to 730 days
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Up to 730 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Respiratory Syncytial Virus (RSV) Neutralization A2
Lasso di tempo: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
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Days 1, 29, 183, 365, 393, 547, 730
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RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Lasso di tempo: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
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Days 1, 29, 183, 365, 393, 547, 730
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Intracellular Cytokine Staining
Lasso di tempo: Day 1, 29, 183, 365, 393, 547, 730
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The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
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Day 1, 29, 183, 365, 393, 547, 730
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 novembre 2016
Completamento primario (Effettivo)
14 marzo 2018
Completamento dello studio (Effettivo)
29 gennaio 2019
Date di iscrizione allo studio
Primo inviato
22 settembre 2016
Primo inviato che soddisfa i criteri di controllo qualità
5 ottobre 2016
Primo Inserito (Stima)
6 ottobre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 febbraio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 febbraio 2019
Ultimo verificato
1 febbraio 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CR108214
- VAC18193RSV1003 (Altro identificatore: Janssen Vaccines & Prevention B.V.)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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