Clinical trial NCT02360475: Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Official title: An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Vaccine
Immunogenicity
Safety
Respiratory syncytial virus (RSV)
Reactogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 507
Sex: FEMALE
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 study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women 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.
* Non-pregnant female between, and including, 18 and 45 years of age at the time of study 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 study vaccination, and
  * Has a negative pregnancy test on the day of study vaccination, and
  * Has agreed to continue adequate contraception during the study period.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, 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.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.
* Previous experimental vaccination against RSV.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component of Boostrix.
* History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
* History of any neurological disorders or seizures
* History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of or current autoimmune disease.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* Malignancy within previous 5 years or lymphoproliferative disorder.
* Current alcohol and/or drug abuse.
* Acute disease and/ or fever at the time of enrolment.
* Hypersensitivity to latex.
* Pregnant or lactating female.
* Planned move to a location that will prohibit participating in the trial until study end.
* Any other condition that the investigator judges may interfere with study procedures or findings.

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
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 vaccination at Day 0, up to Day 30 post-vaccination
measure: Titres of RSV-A Neutralizing Antibodies
timeFrame: At Day 0 pre-vaccination
measure: Titres of RSV-A Neutralizing Antibodies
timeFrame: At Day 30 post-vaccination
Secondary outcomes:
measure: Titres of RSV-A Neutralizing Antibodies
timeFrame: At Day 60 post-vaccination
measure: Titres of RSV-A Neutralizing Antibodies
timeFrame: At Day 90 post-vaccination
measure: Concentrations of Palivizumab Competing Antibodies (PCA)
timeFrame: At Day 0 pre-vaccination
measure: Concentrations of PCA
timeFrame: At Day 30 post-vaccination
measure: Concentrations of PCA
timeFrame: At Day 60 post-vaccination
measure: Concentrations of PCA
timeFrame: At Day 90 post-vaccination
measure: Number of Subjects With SAEs
timeFrame: Up to study end at Day 360
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Dippoldiswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, Andre B, Ingels DC, Louckx M, Dewe W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17.
citation: Beran J, Lickliter JD, Schwarz TF, Johnson C, Chu L, Domachowske JB, Van Damme P, Withanage K, Fissette LA, David MP, Maleux K, Schmidt AC, Picciolato M, Dieussaert I. Safety and Immunogenicity of 3 Formulations of an Investigational Respiratory Syncytial Virus Vaccine in Nonpregnant Women: Results From 2 Phase 2 Trials. J Infect Dis. 2018 Apr 23;217(10):1616-1625. doi: 10.1093/infdis/jiy065.