- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01302990
Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults
15 août 2013 mis à jour par: Medicago
This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
100
Phase
- La phase 1
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
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Maryland
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Rockville, Maryland, États-Unis, 20850
- Accelovance
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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
Inclusion Criteria:
- Male and female adults, 18 to 49 years of age;
- Healthy as judged by the Principal Investigator (PI) or designee and determined by medical history, physical examination, vital signs, screening laboratories and medical history conducted no more than 30 days prior to study vaccine administration;
- BMI of ≥ 18 and ≤ 32;
- Comprehension of the study requirements, expressed availability for the required study period and ability to attend scheduled visits;
- Accessible by telephone on a consistent basis;
- In the opinion of the Investigator, competence and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee;
- Showing a HI titer < 1/40 for the swine-origin A/California/07/2009 H1N1-like X-179A strain in sera during the screening period;
- If female and of childbearing potential, have a negative serum pregnancy test result prior vaccination. Female who are post menopausal (no spotting at all) for at least 2 years will not require a pregnancy test;
- If female and capable of childbearing, has been consistently using effective birth control for the 28 days prior to vaccination. An example of highly effective birth control is oral contraceptives, hormone implants, abstinence (confirmed by Investigator), or male condom plus spermicide. All female and of childbearing potential, must provide a serum sample for pregnancy screening. Female of child bearing potential (except subjects in a same sex relationship) must agree to continue employing adequate birth control measures for at least 60 days post vaccination and must have no plan to become pregnant for at least 60 days post vaccination;
Exclusion Criteria:
Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
- Requiring a new medical or surgical treatment within one month prior to study vaccine administration;
- Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration;
- Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting;
- Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease;
- Presence of any febrile illness, oral temperature of > 38.0˚C (100.4˚F) within 24 hours prior to randomization. Such subjects may be re-evaluated for randomization after resolution of illness;
- History of autoimmune disease;
- Administration of any vaccine (including any other influenza vaccine) within a 30 day period prior to study enrollment, or planned administration within the period from the first vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to study vaccine administration. Receipt of any other emergency immunizations (e.g. rabies) will result in a case-by-case review by the medical monitor of continued participation;
- Use of any investigational or non-marketed product within 30 days prior to study enrollment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study;
- Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of first study vaccine administration, or any other cytotoxic or immunosuppressant drug within three months of vaccination.
- Use of any immune globulin product
- Use of high dose inhaled steroids or oral and parenteral high dose steroid medications. Nasal steroids are allowed. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin [eg</= 325 mg/day (1 regular adult aspirin) or </= 81 mg/day (1 baby aspirin)], and without a clinically apparent bleeding tendency are eligible;
- History of allergy to any of the constituents of H1 VLP (H1N1) study vaccine, or the phosphate buffer;
- History of allergy to egg-based vaccines such as allergy or hypersensitivity to egg proteins.
- History of severe allergic reactions or anaphylaxis or severe asthma;
- History of tobacco allergy;
- History of anti-histaminics used continuously for 4 weeks or more at any time in the past year, prior to randomization;
- Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
- Have received a blood transfusion within 90 days prior to vaccination;
- If female, either known pregnancy or urine beta-human chorionic gonadotropin (ß-hCG) test results consistent with pregnancy during the screening period and prior to study vaccine administration on Day 0;
- Female subjects who are lactating;
- Any vital sign abnormalities: systolic blood pressure, diastolic blood pressure, resting pulse rate or not well controlled and according to the Investigator's opinion;
- Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible.
- Subject with a history of Gillian Barre Syndrome
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 parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
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Dose given by intramuscular administration (0.5 mL)
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Expérimental: 5 micrograms H1 VLP
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Dose given by intramuscular administration (0.5 mL)
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Expérimental: 13 micrograms H1 VLP
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Dose given by intramuscular administration (0.5 mL)
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Expérimental: 28 micrograms H1 VLP
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Dose given by intramuscular administration (0.5 mL)
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Comparateur actif: 45 micrograms Fluzone
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Dose given by intramuscular administration (0.5 mL)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination as a measure of safety and tolerability
Délai: 30 minutes after vaccination
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30 minutes after vaccination
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Percentage, intensity and relationship to vaccination of solicited local and systemic signs and symptoms as a measure of safety and Tolerability
Délai: 7 days after vaccination
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7 days after vaccination
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Percentage, intensity and relationship of solicited and unsolicited local and systemic signs and symptoms 21 days following a single dose of study vaccine as a measure of safety and tolerability
Délai: 21 days after vaccination
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21 days after vaccination
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Occurrences of all adverse events, and serious adverse events during the study as a measure of safety and Tolerability
Délai: 6 months
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6 months
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Occurrences of new onset of a chronic disease (NOCD)during the study as a measure of safety and tolerability
Délai: 6 months
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6 months
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The number and percentage of subjects with normal and abnormal urine, haematological and biochemical values at Screening, Days 21 and 201 as a measure of safety and tolerability
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Immunogenicity
Délai: 21 days and 6-month after injection
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Specific antibodies: Geometric Mean Titers (GMTs) with 95% confidence interval by using the Hemagglutination-Inhibition (HI), MicroNeutralisation (MN) and the Single Radial Hemolysis (SRH) tests; To measure the increase in antibodies directed to plant-specific glycans.
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21 days and 6-month after injection
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: William E Gannon, MD, Accelovance
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
1 février 2011
Achèvement primaire (Réel)
1 juillet 2011
Achèvement de l'étude (Réel)
1 novembre 2011
Dates d'inscription aux études
Première soumission
11 février 2011
Première soumission répondant aux critères de contrôle qualité
23 février 2011
Première publication (Estimation)
24 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 août 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 août 2013
Dernière vérification
1 août 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CP-H1VLP-003
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 .
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