Clinical Trial: A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Observer-blind Study to Rank Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A) Administered to Healthy Women

Brief Summary: The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.

Detailed Summary:

The purpose of the RSV F-021 study that will be conducted in an observer-blind manner during Epoch 1 and single blinded during Epoch 2, is to rank the 3 different doses of the non-adjuvanted investigational RSV PreF-vaccine (30, 60 and 120 μg) based on safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30). Non-pregnant women aged 18-45 years will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 μg) of the RSV PreF vaccine or placebo. The doses eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women. This will allow evaluation of a wider antigen dose range to determine if there is a dose response relationship in terms of antibody response at the higher dose range that was not present at the lower range.

Since in RSV F-021 the 120ug dosage of the PreF-based investigational RSV vaccine will be tested for the first time in humans, appropriate safety monitoring is planned for this study, including pausing enrolment when the first 25% of subjects from each study group have been vaccinated until review of day 7 post-vaccination safety data by an unblinded GSK internal Safety Review Committee (iSRC) has been completed. The enrolment/vaccination of the remaining subjects can only start following the favourable outcome of this iSRC safety review.

In addition to study visits at Day 0, Day 7 and Day 30 to evaluate primary objective of the study, additional study visits are planned at Day 60 and 90 for further investigation of the immunogenicity and safety/reactogenicity profile of the formulations. A follow-up period has been set up in which the subjects will be contacted at Day 180, 270 and 360. During these contacts, the investigator (or delegat
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of subjects with grade 2 and grade 3 solicited general Adverse Events (AEs) [ Time Frame: From vaccination, at Day 0 up to Day 7 ]
  • Number of subjects with grade 2 and grade 3 unsolicited AEs [ Time Frame: From vaccination, at Day 0 up to Day 7 ]
  • Number of subjects with grade 2 and grade 3 fever [ Time Frame: From vaccination, at Day 0 up to Day 7 ]
  • Number of subjects with related serious adverse events (SAEs) [ Time Frame: From vaccination, at Day 0 up to Day 7 ]
  • Neutralising antibody titres against RSV-A [ Time Frame: At Day 0 and Day 30 ]
  • Palivizumab competing antibody (PCA) concentrations [ Time Frame: At Day 0 and Day 30 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of subjects with any solicited local AEs [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]
  • Number of subjects with any solicited general AEs [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]
  • Number of subjects with any unsolicited AEs [ Time Frame: During the 30-day follow-up period (Days 0-29) after vaccination ]
  • Number of subjects with any haematological laboratory abnormalities [ Time Frame: At Day 0 ]
    Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count.
  • Number of subjects with any biochemical laboratory abnormality [ Time Frame: At Day 0 ]
    Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
  • Number of subjects with any haematological laboratory abnormality [ Time Frame: At Day 7 ]
    Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count.
  • Number of subjects with any biochemical laboratory abnormality [ Time Frame: At Day 7 ]
    Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
  • Number of subjects with any haematological laboratory abnormality [ Time Frame: At Day 30 ]
    Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count.
  • Number of subjects with any biochemical laboratory abnormality [ Time Frame: At Day 30 ]
    Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
  • Number of subjects with any haematological laboratory abnormality [ Time Frame: At Day 60 ]
    Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count.
  • Number of subjects with any biochemical laboratory abnormality [ Time Frame: At Day 60 ]
    Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
  • Number of subjects with any haematological laboratory abnormality [ Time Frame: At Day 90 ]
    Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count.
  • Number of subjects with any biochemical laboratory abnormality [ Time Frame: At Day 90 ]
    Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
  • Number of subjects with any SAEs [ Time Frame: Up to study end at Day 360 ]
  • Neutralising antibody titres against RSV-A [ Time Frame: At Day 0 ]
  • Neutralising antibody titres against RSV-A [ Time Frame: At Day 30 ]
  • Neutralising antibody titres against RSV-A [ Time Frame: At Day 60 ]
  • Neutralising antibody titres against RSV-A [ Time Frame: At Day 90 ]
  • Neutralising antibody titres against RSV-B [ Time Frame: At Day 0 ]
  • Neutralising antibody titres against RSV-B [ Time Frame: At Day 30 ]
  • Neutralising antibody titres against RSV-B [ Time Frame: At Day 60 ]
  • Neutralising antibody titres against RSV-B [ Time Frame: At Day 90 ]
  • Palivizumab competing antibody (PCA) concentrations [ Time Frame: At Day 0 ]
  • Palivizumab competing antibody (PCA) concentrations [ Time Frame: At Day 30 ]
  • Palivizumab competing antibody (PCA) concentrations [ Time Frame: At Day 60 ]
  • Palivizumab competing antibody (PCA) concentrations [ Time Frame: At Day 90 ]
  • Antibody concentrations against neogenin (NEO) residual host cell protein [ Time Frame: At Pre-vaccination (Day 0) and 1 month post-vaccination (Day 30) ]
  • Number of subjects with medically attended (MA) respiratory tract infections (RTIs) associated with RSV [ Time Frame: Up to study end at Day 360 ]
    Same as current

    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 3, 2016
    Date Started: November 10, 2016
    Date Completion: March 7, 2018
    Last Updated: April 26, 2017
    Last Verified: April 2017