Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Intervention: GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E; Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)
Intervention description: 2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm; 2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh_NTHi-Mcat_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid of the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This is an open-label study. Blinding was not performed on the subjects.
Enrollment: 541.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Chronic obstructive pulmonary disease (COPD); Non-typeable Haemophilus influenza; Moraxella catarrhalis; Shingrix; Herpes Zoster; Adjuvanted vaccines; Safety

Summary:

      This study will provide information regarding the sequential administration of two vaccines
      adjuvanted with AS01.

      The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when
      administered sequentially after Shingrix vaccine and to compare to the immunogenicity of
      NTHi-Mcat vaccine administered alone. This study will also provide information regarding
      whether a specific time period is required between the administration of these two different
      vaccines containing the same adjuvant- AS01 components.

      The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of
      age which will be used as a proxy for the COPD population.
    

Eligibility 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 occlusion, 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.

        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 topical
             steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products or plasma derivatives
             during the period starting 3 months before the first dose of study vaccine or planned
             administration starting from Day 1 and ending at the second blood draw (i.e.
             approximately 1 month after the planned administration of the second dose of NTHi-Mcat
             vaccine).

          -  Prior/concurrent clinical study experience

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product (drug or medical device).

          -  Other exclusions:

          -  Pregnant or lactating female,

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions,

          -  Current alcoholism and/or drug abuse,

          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study

          -  Any study personnel or immediate dependents, family, or household member.