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A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02491463
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Condition or disease Intervention/treatment Phase
Respiratory Synctial Virus Infections Biological: GSK3389245A_LD GROUP Biological: GSK3389245A_HD GROUP Biological: Bexsero Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Actual Study Start Date : July 23, 2015
Actual Primary Completion Date : April 8, 2016
Actual Study Completion Date : January 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GSK3389245A_LD GROUP
Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose
Biological: GSK3389245A_LD GROUP
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Experimental: GSK3389245A_HD GROUP
Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose
Biological: GSK3389245A_HD GROUP
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Active Comparator: Bexsero Group
Subjects in this group will receive 2 doses, one month apart, of Bexsero
Biological: Bexsero
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
Other Name: Meningococcal group B Vaccine

Placebo Comparator: Placebo Group
Subjects in this group will receive 2 doses, one month apart, of placebo
Drug: Placebo
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm




Primary Outcome Measures :
  1. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

  2. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  3. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 1 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)

  4. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 3 ]
    Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).

  5. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 7 ]
    Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).

  6. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 30 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).

  7. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 31 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).

  8. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 33 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).

  9. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 37 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).

  10. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 60 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).

  11. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 180 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).

  12. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [ Time Frame: At Day 360 ]
    Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).

  13. Number of Subjects With Haematological and Biochemical Results by Maximum Grade [ Time Frame: From Day 1 to Day 60 ]
    Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.

  14. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers 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 out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  15. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 360 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Secondary Outcome Measures :
  1. Number of Subjects With Haematological and Biochemical Results by Maximum Grade [ Time Frame: From Day 1 up to Day 360 ]
    Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.

  2. Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers [ Time Frame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60) ]
    Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).

  3. Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value [ Time Frame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60) ]
    Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.

  4. Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells [ Time Frame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60) ]
    Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.

  5. Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC) [ Time Frame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60) ]
    IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 prior to performing any study specific procedure
  • A male or female between, and including, 18 and 45 years of age at the time of first vaccination
  • Healthy subjects as established by medical history and clinical examination before entering into the study
  • Female subjects of non-childbearing potential may be enrolled in the study
  • 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 vaccina-tion, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

  • 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
  • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration 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 any licensed influenza vaccine which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last dose of study vaccine
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period
  • Blood donation within 4 months prior to study entry or planned blood donation at any time during the study
  • Previous vaccination against RSV
  • Previous vaccination with a recombinant simian or human adenoviral vaccine
  • Previous Bexsero or other vaccination against Neisseria meningitidis serogroup B
  • History of or current autoimmune disease
  • Family history of congenital or hereditary immunodefi-ciency
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • History of any neurological disorders or seizures
  • History of transient thrombocytopenia or neurological complications following any prior vaccination
  • Hypersensitivity to latex
  • Hypersensitivity to Bexsero's active substances or to any of its excipients
  • Allergic reaction to kanamycin
  • Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Acute disease and/or fever at the time of enrolment
  • Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by physical examination or laboratory screening tests
  • Malignancy within previous 5 years or lymphoproliferative disorders
  • Any clinically significant or any ≥ Grade 2 haematological laboratory abnormality
  • Body mass index > 40 kg/m2
  • Current alcohol and/or drug abuse
  • Pregnant or lactating female
  • Any other condition that the investigator judges may interfere with study procedures or findings
  • Planned move to a location that will prohibit participating in the trial until study end

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491463


Locations
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United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02491463    
Other Study ID Numbers: 201974
First Posted: July 8, 2015    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018
Last Verified: May 2018
Keywords provided by GlaxoSmithKline:
Reactogenicity
Safety
Respiratory syncytial virus (RSV)
Vaccine
Immunogenicity
Additional relevant MeSH terms:
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Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs