Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

NCT02360475 | Completed Phase 2 Results

• 2 other identifiers: 2015102014-002688-14
• Study Type: interventional
• Target: 507
• Locations: 4 countries
• Sites: 12

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Vaccine; Immunogenicity; Safety; Respiratory syncytial virus (RSV); Reactogenicity

Outcome Measures

Primary Outcomes (6)

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Unsolicited Adverse Events (AEs)

  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 outside 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.

  During the 30-Day (Days 0-29) post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  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.

  From vaccination at Day 0, up to Day 30 post-vaccination

• Titres of RSV-A Neutralizing Antibodies

  RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

  At Day 0 pre-vaccination

• Titres of RSV-A Neutralizing Antibodies

  RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

  At Day 30 post-vaccination

Secondary Outcomes (7)

• Titres of RSV-A Neutralizing Antibodies

  At Day 60 post-vaccination

• Titres of RSV-A Neutralizing Antibodies

  At Day 90 post-vaccination

• Concentrations of Palivizumab Competing Antibodies (PCA)

  At Day 0 pre-vaccination

• Concentrations of PCA

  At Day 30 post-vaccination

• Concentrations of PCA

  At Day 60 post-vaccination

Study Arms (4)

RSV vaccine formulation 1 Group

EXPERIMENTAL

Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine

Biological: RSV vaccine GSK3003895A (formulation 1)

RSV vaccine formulation 2 Group

EXPERIMENTAL

Subjects in this group will receive a single dose of formulation 2 of RSV vaccine

Biological: RSV vaccine GSK3003898A (formulation 2)

RSV vaccine formulation 3 Group

EXPERIMENTAL

Subjects in this group will receive a single dose of formulation 3 of RSV vaccine

Biological: RSV vaccine GSK3003899A (formulation 3)

Boostrix Group

ACTIVE COMPARATOR

Subjects in this group will receive a single dose of Boostrix

Biological: Boostrix

Interventions

RSV vaccine GSK3003895A (formulation 1) BIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

RSV vaccine formulation 1 Group

RSV vaccine GSK3003898A (formulation 2) BIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

RSV vaccine formulation 2 Group

RSV vaccine GSK3003899A (formulation 3) BIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

RSV vaccine formulation 3 Group

Boostrix BIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Boostrix Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Mesa, Arizona, 85213, United States

Location

GSK Investigational Site

San Diego, California, 92108, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Milford, Massachusetts, 01757, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Hradec Králové, Czechia

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Dippoldiswalde, Saxony, 01744, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23554, Germany

Location

Related Publications (2)

• 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.

  PMID: 31951765 DERIVED

• 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.

  PMID: 29401325 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

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 2
• 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: January 29, 2015
• First Posted: February 10, 2015
• Study Start: March 20, 2015
• Primary Completion: July 2, 2015
• Study Completion: June 21, 2016
• Last Updated: July 3, 2018
• Results First Posted: August 16, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

AU (1); CZ (1); DE (3); US (7)