Healthy volunteers (chronic obstructive pulmonary disorder [COPD])) MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Vacuna multiantigénica de Haemophilus influenzae no tipable y Moraxella catarrhalis (NTHi-Mcat)
Product Code: NTHi-Mcat
Pharmaceutical Form: Powder and suspension for suspension for inje
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). • Written informed consent obtained from the subject prior to performance of any study specific procedure. • A male or female between, and including, 50 years and 80 years of age at the time of the first vaccination. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Current or former smoker with a cigarette smoking history =10 pack-years. • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlu-sion, hysterectomy, bilateral ovariectomy or post-menopause. • Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and; has a negative pregnancy test on the day of vaccination, and; has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Medical conditions • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of potential immune-mediated disease (pIMD). Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated. The investigator will exercise his/her medical and scientific judgement in deciding whether other diseases have an autoimmune origin and thus meet the exclusion criteria. • Diagnosis of COPD regardless of severity. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex –gloves, syringes, etc). • Has significant disease (including significant psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration. • History of or current condition preventing intramuscular injection as bleeding or coagulation disorder. • Malignancies within previous 5 years (excluding non-melanoma skin cancer) or lymphoproliferative disorders. Prior/concomitant therapy • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period. • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of non-MF59 adjuvanted influenza vaccines and pneumococcal vaccines which may be administered =15 days preceding or following any study vaccine dose. Note: For M59 adjuvanted flu vaccine and for any vaccine containing novel adjuvant refer to exclusion criteria below. • Planned administration/administration of a vaccine adjuvanted with the following adjuvants AS01, AS02, AS03, AS04 and MF59 in the period starting 6 months before the first dose of study vaccine, and ending at the second blood draw (i.e. approximately 1 month after the administration of the last dose of NTHi-Mcat vaccine). The following non-exhaustive list should be considered as criteria for exclusion: Prepandrix, Adjupanrix, Shingrix, Fendrix, Cervarix, FluAd, Chiromas, Gripguard. • Previous vaccination with any vaccine containing NTHi and/or Mcat antigens; . • Previous vaccination with Shingrix; (either registered product or participation in a previous vaccine study). • Previous vaccination with HZ live-attenuated vaccine (ZVL)) (either registered product or participation in a previous vaccine study) within the 2 months of the first study visit (Day 1). • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose, and ending at the second blood draw. (i.e. approximately 1 month after the administration of the last dose of NTHi-Mcat vaccine). For corticosteroids, this will mean prednisone =5 mg/day (for adult subjects), or equivalent. Only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the safety and reactogenicity profile of GSK Biologicals' NTHi-Mcat investigational vaccine when adminis-tered 1 or 3 or 6 months after Shingrix vaccine or when administered alone. • To describe the humoral immune response of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 or 3 or 6 months after Shingrix vaccine or when adminis-tered alone. • To describe the cell-mediated immune (CMI) response of GSK Biologicals’ NTHi-Mcat investigational vaccine when administered 1 or 3 or 6 months after Shingrix vaccine or when NTHi-Mcat is administered alone, in the CMI response subcohort.;Primary end point(s): Anti-PD, anti-PE, anti-PilA and anti-UspA2 antibody concentra-tions in terms of Geometric Mean Concentrations (GMCs), one-month post Dose-2 of NTHi-Mcat vaccine. Antibody concentrations are measured by ELISA (Enzyme-linked immunosorbent assay) and expressed as GMCs in ELISA units per milliliter (EU/mL). Cut-off value for the assay is 153, 25 ,16 and 38 EU/mL for anti-PD, anti-PE, anti-PilA and anti-UspA2 antibodies respectively.;Timepoint(s) of evaluation of this end point: At 1 month after Dose 2 of NTHi-Mcat vaccine (Day 181 [Sh_NTHi-Mcat_1], Day 241 [Sh_NTHi-Mcat_3] and Day 331 [Sh_NTHi-Mcat_6], and Day 91 [NTHi-Mcat]);Main Objective: • To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 or 3 or 6 months after Shingrix vaccine versus the humoral im-mune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine alone. Criterion: NI will be demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (Sh_NTHi-Mcat/NTHi-Mcat) is above a limit of 0.667 for all anti-Protein D (PD), anti-Protein E (PE), anti-type IV pili subunit (PilA), anti- ubiquitous surface protein A2 of Moraxella catarrhalis (Us-pA2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity 1. Anti–PD, anti-PE, anti-PilA, anti-UspA2 antibody concentrations in terms of GMCs, before the first dose of NTHi-Mcat vaccine. Note: GMCs and their 95% CI for each of the antibodies, as measured by ELISA, are calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations) before the first dose of NTHi-Mcat vaccine 2. Percentage of seropositive subjects for anti-PD, anti-PE, anti-PilA, anti-UspA2 antibodies before first NTHi-Mcat vaccine. 3. Percentage of subjects seropositive for anti-PD, anti-PE, anti-PilA, anti-UspA2 antibodies, at 1 month post Dose-2 of NTHi-Mcat vaccine. Note: A seropositive subject is defined as a subject whose anti-PD, anti-PE, anti-PilA and anti-UspA2 antibody concentrations are greater than or equal to the assay cut-off value. Seropositivity rates with 95% CI are defined using the assay lower limit of quantification (LLOQ). Seropositivity rates are calculated before the first dose of NTHi-Mcat Vaccine and at 1 month post Dose-2 of NTHi-Mcat vaccine 4. Frequency of specific Cluster of Differentiation 4 (CD4+) T-cells against NTHi and Mcat antigens for evaluation of cell-mediated immune (CMI) response, before the first dose of NTHi-Mcat vaccine. 5. Frequency of CD4+ T-cells against NTHi and Mcat antigens for evaluation of CMI response, at 1-month post Dose 2 of NTHi-Mcat vaccine. Note: Frequency of specific CD4+ T-cells is measured by flow cytome-try intracellular cytokine staining (ICS) expressing at least 2 different cytokines/activation markers among CD40 Ligand (CD40L), interleukin (IL)-2, IL-13, IL-17, tumour necrosis factor alpha (TNF-a) and interferon gamma (IFN-?), upon in vitro stimulation. Safety 6. Percentage of subjects with reported solicited local adverse event (AE) Note: The percentage of subjects with at least 1 local solicited AE, regardless of intensity, during the 7-day follow-up period after each vaccination, are reported | — |
Countries
Finland, France, Italy, Spain
Contacts
Public ContactCentro de Información
GlaxoSmithKline S.A.
Outcome results
None listed