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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03894969
• Date of registration: 27/03/2019
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: 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
• Scientific title: Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine
• Date of first enrolment: April 23, 2019
• Target sample size: 542
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03894969
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Estonia, Finland, France, Italy, Spain

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Disorders

Intervention(s)

Biological: Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)

Biological: GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E

Primary Outcome(s)

Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV pili subunit (PilA) and Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), one-month post Dose-2 of NTHi-Mcat vaccine [Time Frame: At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181, in Sh_NTHi-Mcat_1 group and Day 91 in NTHi-Mcat group)]

Secondary Outcome(s)

Frequency of CD4+ T-cells against NTHi and Mcat antigens for evaluation of CMI response, at one-month post dose 2 of NTHi-Mcat vaccine [Time Frame: At one month after second dose of NTHi-Mcat vaccine (Day 181, Day 241 and Day 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)]

Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 antibody concentrations in terms of GMCs, before first NTHi-Mcat vaccine [Time Frame: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 for Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 for NTHi-Mcat group)]

Percentage of subjects with any serious adverse event (SAE) during Epoch 001 [Time Frame: From Day 1 up to and including Day 331 (Epoch 001)]

Percentage of subjects with reported solicited local adverse event (AE) [Time Frame: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine]

Frequency of specific Cluster of Differentiation 4 (CD4+) T-cells against NTHi and Mcat antigens for evaluation of cell-mediated immune (CMI) response, before first dose of NTHi-Mcat vaccine [Time Frame: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 in the NTHi-Mcat group)]

Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 antibody concentrations in terms of GMCs, one-month post Dose-2 of NTHi-Mcat vaccine [Time Frame: At one month after the second dose of NTHi-Mcat vaccine (Day 181, 241, 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)]

Percentage of subjects seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 antibodies, one-month post Dose-2 of NTHi-Mcat vaccine [Time Frame: At one month after the second dose of NTHi-Mcat vaccine (Day 181, 241, 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)]

Percentage of subjects with any pIMD's during Epoch 002 [Time Frame: From Day 331 up to and including Day 661 (Epoch 002)]

Percentage of subjects with any Potential Immune-mediated diseases (pIMD's) during Epoch 001 [Time Frame: From Day 1 up to and including Day 331 (Epoch 001)]

Percentage of subjects with any SAE during Epoch 002 [Time Frame: From Day 331 up to and including Day 661 (Epoch 002)]

Percentage of subjects with any unsolicited AE [Time Frame: During the 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine]

Percentage of seropositive subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 antibodies before first NTHi-Mcat vaccine [Time Frame: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 in the NTHi-Mcat group)]

Percentage of subjects with reported solicited general AE [Time Frame: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine]

Secondary ID(s)

2018-002977-24

209538

Source(s) of Monetary Support

Please refer to primary and secondary sponsors