- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03232567
Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
19 mars 2019 mis à jour par: Altimmune, Inc.
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.
Subjects will be screened within 28 days of randomization (Day 1).
Aperçu de l'étude
Description détaillée
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.
Subjects will be screened within 28 days of randomization (Day 1).
Approximately 60 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 3 sequential cohorts of 20 subjects each defined by the viral particle dose (1×10(9th), 1×10(10th), and 1×10(11th) vp).
Within each cohort and its sentinel group, subjects will be randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo (Day 1).
A sentinel group of 5 subjects from each cohort will be dosed and followed through Day 8. Dosing of the remainder of each cohort may proceed if no events meeting stopping criteria have occurred.
The SRC, consisting of the Investigator, the Medical Monitor, and a Sponsor Representative, will review AE, reactogenicity, and laboratory data through Day 8 for all subjects in each cohort before subjects are randomized to the next higher dose.
If any event meeting stopping criteria occur, the SRC will review all available safety information before additional patients are dosed.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Maryland
-
Rockville, Maryland, États-Unis, 20850
- Optimal Health Research
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 49 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Subjects who meet all of the following criteria may be included in the study:
- Men and women 18 to 49 years of age, inclusive
- Good general health status as determined by the Investigator
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
- Negative drug and alcohol screen at Screening and predose on Day 1
- For women who have not been surgically sterilized or have laboratory confirmation of postmenopausal status, negative pregnancy test
- Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the NasoVAX/placebo dose
- Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
- Provision of written informed consent
Subjects who meet any of the following criteria will be excluded from the study:
- Pregnant, possibly pregnant, or lactating women
- Household contacts of pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Persons who care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Body mass index > 35.0 kg/m2
- Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening
Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with the any of the following events in the past year:
- Daily symptoms
- Daily use of short acting beta 2 agonists
- Use of inhaled steroids or theophylline
- Use of pulse systemic steroids
- Emergency care or hospitalization related to asthma or other chronic lung disease
- Systemic steroids for asthma exacerbation
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
- History of coronary artery disease, arrhythmia, or congestive heart failure
- Clinically significant ECG abnormality as determined by the Investigator
- Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1
- History of anaphylaxis or angioedema
- Known allergy to any of the ingredients in the vaccine formulation
- History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
- Previous nasal surgery or nasal cauterization
- Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1
- Any symptoms within 24 hours before Day 1 of upper respiratory illness of allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP
- Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
- Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
- Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1)
- Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
- Receipt of any investigational product (IP) within 30 days before Day 1
- Receipt of any vaccine within 30 days before Day 1
- Receipt of intranasal vaccine within 90 days before Day 1
- Receipt of any influenza vaccine within 6 months before Day 1
- Any change in medication for a chronic medical condition within 30 days before Day 1
- Past regular use or current use of intranasal illicit drugs
- Smoking of any type (eg, cigarettes, electronic cigarettes, marijuana) or use of any tobacco product within 30 days before Day 1
- Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: NasoVAX low dose
NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo
|
Single ascending dose study
|
Expérimental: NasoVAX medium dose
NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo
|
Single ascending dose study
|
Expérimental: NasoVAX high dose
NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
|
Single ascending dose study
|
Comparateur placebo: Placebo
Normal saline administered by intranasal spray at a single dose
|
Single ascending dose study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Délai: Day 1 to Day 181
|
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
|
Day 1 to Day 181
|
Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]
Délai: 14-days after vaccination
|
Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
|
14-days after vaccination
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
HAI Immune Response
Délai: Day 1 to Day 181
|
Antibody level measured by hemagglutination inhibition (HAI) in serum
|
Day 1 to Day 181
|
Microneutralization Immune Response
Délai: Day 1 to Day 181
|
Antibody level measured by microneutralization in serum
|
Day 1 to Day 181
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Stephen Bart, MD, Optimal Research
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 septembre 2017
Achèvement primaire (Réel)
7 mars 2018
Achèvement de l'étude (Réel)
15 juin 2018
Dates d'inscription aux études
Première soumission
24 juillet 2017
Première soumission répondant aux critères de contrôle qualité
27 juillet 2017
Première publication (Réel)
28 juillet 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ALT103-201
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Grippe
-
Mitsubishi Tanabe Pharma CorporationComplété
-
Jiangsu Province Centers for Disease Control and...Royal (Wuxi) Biological Co., LTDComplétéGroupe A, C Méningite polysaccharidique | Haemophilus Influenza de type bChine
-
Jiangsu Province Centers for Disease Control and...Chengdu Olymvax Biopharmaceuticals Inc.Complété
-
University Hospital, LilleCSL Behring; Laboratoire français de Fractionnement et de Biotechnologies; O... et autres collaborateursRésiliéInfections pneumococciques | Pneumonie bactérienne | Méningite bactérienne | Otite moyenne | Infection chronique des sinus | Infection streptococcique | Déficit en anticorps | Carence en complément | Infections à Neisseria | Haemophilus InfluenzaFrance
-
QIAGEN Gaithersburg, IncComplétéInfections par le virus respiratoire syncytial | Grippe A | Rhinovirus | Grippe B | Panneau avancé QIAGEN ResPlex II | Infection due au virus parainfluenza humain 1 | Parainfluenza de type 2 | Parainfluenza de type 3 | Parainfluenza de type 4 | Métapneumovirus humain A/B | Virus/échovirus Coxsackie | Adénovirus... et d'autres conditionsÉtats-Unis