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

NCT ID: NCT02491463

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-23
• Study Completion Date: 2017-01-26

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.

Conditions

Respiratory Synctial Virus Infections

Study Design

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

Study Groups

GSK3389245A_LD GROUP

Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose

Group Type: EXPERIMENTAL

GSK3389245A_LD GROUP

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

GSK3389245A_HD GROUP

Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose

Group Type: EXPERIMENTAL

GSK3389245A_HD GROUP

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Bexsero Group

Subjects in this group will receive 2 doses, one month apart, of Bexsero

Group Type: ACTIVE_COMPARATOR

Bexsero

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Placebo Group

Subjects in this group will receive 2 doses, one month apart, of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Interventions

GSK3389245A_LD GROUP

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

GSK3389245A_HD GROUP

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

Bexsero

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

Placebo

2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Intervention Type: DRUG

Other Intervention Names

Meningococcal group B Vaccine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31340042 (View on PubMed)

Other Identifiers

201974

Identifier Type: -

Identifier Source: org_study_id