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

NCT02547974 | Completed Phase 1 Results

• 2 other identifiers: 2012812015-000378-36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

Safety; Immunogenicity; Reactogenicity

Outcome Measures

Primary Outcomes (13)

• Number of Subjects With Any Solicited Local Adverse Events (AEs)

  Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  During a 7-day follow-up period (Day 0 to Day 6) after first dose.

• Number of Subjects With Any Solicited Local Adverse Events (AEs)

  Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  During a 7-day follow-up period (Day 60 to Day 66) after second dose

• Number of Subjects With Any Solicited General Adverse Events (AEs)

  Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].

  During a 7-day follow-up period (Day 0 to Day 6) after first dose.

• Number of Subjects With Any Solicited General Adverse Events (AEs)

  Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].

  During a 7-day follow-up period (Day 60 to Day 66) after second dose.

• Number of Subjects With Any Unsolicited Adverse Events (AEs).

  Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  During a 30-day follow-up period (Day 0 to Day 29) after first dose.

• Number of Subjects With Any Unsolicited Adverse Events (AEs)

  Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  During a 30-day follow-up period (Day 60 to Day 89) after second dose

• Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.

  Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

  At Day 7, post-dose 1.

• Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination

  Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

  At Day 60, post-dose 1.

• Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination

  Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

  At Day 67, post-dose 2.

• Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination

  Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

  At Day 210, post-dose 2.

• Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination

  Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.

  At Day 420, post-dose 2.

• Number of Subjects With Any Serious Adverse Events (SAEs)

  Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  From first vaccination up to study conclusion (Day 0 to Day 420)

• Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)

  Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  From first vaccination up to study conclusion (Day 0 to Day 420)

Secondary Outcomes (7)

• Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component

  At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).

• Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component

  At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).

• Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component

  At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).

• Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component

  At Day 210 and Day 420 (post-dose2).

• Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component

  At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).

Study Arms (4)

GSK3277513A F1 Group

EXPERIMENTAL

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.

Biological: Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A

GSK3277513A F2 Group

EXPERIMENTAL

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.

Biological: Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A

GSK3277513A F3 Group

EXPERIMENTAL

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.

Biological: Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A 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 F1 Group

Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A 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

Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A 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

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• 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.

  PMID: 31029515 DERIVED

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 14, 2015
• Study Start: August 31, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: August 31, 2018
• Results First Posted: July 23, 2018

Record last verified: 2018-03

Locations

BE (3)