Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women
10 décembre 2013 mis à jour par: Michelle Groome, University of Witwatersrand, South Africa
Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.
The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013.
Safety data including solicited local and systemic reactions to the vaccine will also be assessed.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Schedule of Events
Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed
Local/ systematic reactions
Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed
Type d'étude
Interventionnel
Inscription (Réel)
105
Phase
- Phase 4
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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Gauteng
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Soweto, Gauteng, Afrique du Sud
- Nrf/Dst Vpd Rmpru
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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 39 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
(i) Documented to be HIV-1 infected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of study.
- Not pregnant at time of enrolment (confirmed by urine testing). If pregnant in past year, participant must be at least 6 months post delivery at time of enrolment.
- Women age ≥ 18 years to < 39 years.
Exclusion Criteria:
- Receipt of TIV, other than through the study, during the current and previous two influenza seasons, documented by medical history or record.
- Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
- Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained.
- Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
- Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
- Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
- Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products.
- Receipt of Interleukin 2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
- Uncontrolled major psychiatric disorder.
- History of a severe adverse reaction to previous TIV.
- 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.
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: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Trivalent Inactivated Influenza Vaccine
Single dose, intramuscular injection from a pre-filled syringe WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
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WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
Délai: one month post vaccination
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Humoral immunity will be measured by hemagglutination inhibition (HAI) assay, which has been extensively used for this purpose.
In healthy individuals, HAI titers ≥1:10 indicate presence of influenza-specific antibodies and ≥1:40 protection against infection and disease.
In this study we will use the following definitions to assess the humoral immune response to TIV: HAI titers <1:10 = seronegative; HAI titers ≥1:10 = seropositive; HAI titers ≥1:40 = sero-protective titers; and sero-conversion will be defined as HAI titers from <1:10 to ≥1:40 or ≥4-fold increase if pre-vaccination titers were ≥1:10.
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one month post vaccination
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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impact of vaccination on T-cell activation and on T- and B-cell subpopulations
Délai: one month post vaccination
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T-lymphocyte activation assays will be performed using state-of-the art polychromatic flow cytometry.
The T- and B-cell phenotypes are assessed by flow cytometry using freshly thawed Peripheral Blood Mononuclear Cells (PBMC).
Cells are stained using monoclonal antibodies against the comparator molecules.
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one month post vaccination
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Impact of Vaccination of Cell Mediated Immune (CMI) Responses
Délai: one month post vaccination
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Interferon(IFN)Enzyme Linked Immuno Spot (ELISPOT) responses will be used to assess CMI responses to influenza vaccines.PBMCs will be separated and stimulated with influenza virus corresponding to the vaccine strains.
Spots will be visualized with a ELISPOT plate reader.
Results will be reported as Spot Forming Cells(SFC)/106 PBMCs.
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one month post vaccination
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Local and Systemic solicited reactions to TIV
Délai: 1 week and one month post vaccination
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Participants will remain in the clinic for at least 30 minutes after vaccination so that clinic personnel can observe participants for any potential adverse reactions.Report of vaccine-related local (redness, swelling, tenderness, itching,) and systemic (fever, malaise, myalgia, nausea, headache, rash) adverse events will be solicited at day 7 and day 28.
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1 week and one month post vaccination
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safety outcome measures of TIV
Délai: within one month post vaccination
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Safety and tolerability of the study vaccine will be monitored by means of Adverse Events (AEs) and toxicity reports presenting laboratory and clinical data.Toxicities will be classified by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,
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within one month post vaccination
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
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 mai 2013
Achèvement primaire (Réel)
1 juillet 2013
Achèvement de l'étude (Réel)
1 juillet 2013
Dates d'inscription aux études
Première soumission
13 mars 2013
Première soumission répondant aux critères de contrôle qualité
13 mars 2013
Première publication (Estimation)
18 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
11 décembre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 décembre 2013
Dernière vérification
1 décembre 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Maladies du système immunitaire
- Infections à Orthomyxoviridae
- Maladies à virus lents
- Infections à VIH
- Grippe humaine
- Syndrome immunodéficitaire acquis
- Syndromes d'immunodéficience
Autres numéros d'identification d'étude
- MatFlu_HIVpos_nonpregnant
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 .