Clinical trial NCT02491463: A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Synctial Virus Infections
Keywords: Reactogenicity
Safety
Respiratory syncytial virus (RSV)
Vaccine
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 1
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 3
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 7
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 30
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 31
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 33
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 37
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 60
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 180
measure: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
timeFrame: At Day 360
measure: Number of Subjects With Haematological and Biochemical Results by Maximum Grade
timeFrame: From Day 1 to Day 60
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 360
Secondary outcomes:
measure: Number of Subjects With Haematological and Biochemical Results by Maximum Grade
timeFrame: From Day 1 up to Day 360
measure: Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
timeFrame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
measure: Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
timeFrame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
measure: Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
timeFrame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)
measure: Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
timeFrame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Cicconi P, Jones C, Sarkar E, Silva-Reyes L, Klenerman P, de Lara C, Hutchings C, Moris P, Janssens M, Fissette LA, Picciolato M, Leach A, Gonzalez-Lopez A, Dieussaert I, Snape MD. First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Clin Infect Dis. 2020 May 6;70(10):2073-2081. doi: 10.1093/cid/ciz653.