A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.

NCT ID: NCT02547974

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-31

Brief Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults

Conditions

Respiratory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GSK3277513A F1 Group

Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.

Group Type: EXPERIMENTAL

Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A

Intervention Type: BIOLOGICAL

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

GSK3277513A F2 Group

Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.

Group Type: EXPERIMENTAL

Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A

Intervention Type: BIOLOGICAL

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

GSK3277513A F3 Group

Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.

Group Type: EXPERIMENTAL

Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A

Intervention Type: BIOLOGICAL

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Placebo Group

Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Interventions

Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Intervention Type: BIOLOGICAL

Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Intervention Type: BIOLOGICAL

Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Intervention Type: BIOLOGICAL

Placebo

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

applicable for both Step 1 ((healthy volunteers) and Step 2 ([ex-]smokers)

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, hysterectomy, 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 vacci-nation, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

only applicable for Step 1

• A male or female between, and including, 18 and 40 years of age at the time of the Screening Visit.
• Healthy subjects without acute or chronic, clinically sig-nificant pulmonary, cardiovascular, hepatic or renal func-tional abnormality, as determined by physical examination or laboratory screening tests.

only applicable for Step 2

• A male or female between, and including, 50 and 70 years of age at the time of the screening visit.
• Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
• Current or former smoker with a cigarette smoking history ≥ 10 pack-years.

Exclusion Criteria

applicable for both Step 1 and Step 2

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• 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.
• Previous vaccination with any vaccine containing NTHi and/or Mcat antigens.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Only topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of or current autoimmune disease.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature >= 37.5°C for oral or axillary route. The preferred route for recording temperature in this study will be oral.
• Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
• Current alcoholism and/or drug abuse.
• History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
• Malignancies within previous 5 years or lymphoproliferative disorders.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any other condition that the investigator judges may interfere with study findings.

only applicable for Step 1

• 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, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
• Laboratory evidence of clinically significant haematological (complete blood cell count [RBC, WBC], WBC differential count [lymphocytes, neutrophils and eosinophils], platelets count or haemoglobin level) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine) abnormalities as per the opinion of the investigator.

only applicable for Step 2

• 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, with the exception of any influenza or pneumococcal licensed vaccine which may be admin-istered ≥ 15 days preceding or following any study vaccine dose.
• Post-bronchodilator FEV1 < 80% of predicted normal value.
• Diagnosed with a respiratory disorder (e.g. asthma, COPD, sarcoidosis, tuberculosis, bronchiectasis, lung fi-brosis, pulmonary embolism, pneumothorax, or physi-cian confirmed lung cancer). Please note that subjects with mild pulmonary obstruction (i.e. FEV1/ FVC ratio < 0.7 with FEV1 ≥ 80% of normal predicted values [GOLD grade 1]) can be enrolled.
• Has contraindication for spirometry testing (such as recent eye surgery, recent thoracic or abdominal surgery procedures, unstable cardiovascular status, recent myo-cardial infection or pulmonary embolism).
• Laboratory evidence of clinically significant haematological (complete blood cell count [RBC, WBC], WBC differential count [lymphocytes, neutrophils and eosinophils], platelets count or haemoglobin level) and biochemical (ALT, AST or creatinine) abnormalities.
• Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Wilrijk, , Belgium

Countries

Belgium

References

Van Damme P, Leroux-Roels G, Vandermeulen C, De Ryck I, Tasciotti A, Dozot M, Moraschini L, Testa M, Arora AK. Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine. Vaccine. 2019 May 21;37(23):3113-3122. doi: 10.1016/j.vaccine.2019.04.041. Epub 2019 Apr 24.

Reference Type: DERIVED

PMID: 31029515 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000378-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

201281

Identifier Type: -

Identifier Source: org_study_id