Phase 2
Completed N=400
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
Source: ClinicalTrials.gov NCT02956837 ↗Enrolled (actual)
400
Serious AEs
2.0%
Results posted
Nov 2018
Primary outcomePrimary: Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited — 32; 30; 24; 27 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited |
32; 30; 24; 27 | — |
| PRIMARY Number of Subjects With Grade 2 and Grade 3 Fever |
0; 2; 1; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Related Serious Adverse Events (SAEs) |
0; 0; 0; 0 | — |
| PRIMARY Neutralizing Antibody Titers Against RSV-A Subtype |
715.4; 831.9; 965.1; 311.6; 566.5; 732.1 | — |
| PRIMARY Palivizumab Competing Antibody (PCA) Concentrations |
55.2; 69.0; 66.7; 6.4; 47.6; 57.9 | — |
| PRIMARY Pavilizumab Competing Antibody (PCA) Concentrations |
66.8; 81.2; 83.7; 6.1 | — |
| SECONDARY Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs |
52; 52; 51; 11; 5; 5 | — |
| SECONDARY Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs |
47; 43; 45; 42; 9; 14 | — |
| SECONDARY Number of Subjects With Any Unsolicited AEs |
55; 52; 46; 49 | — |
| SECONDARY Number of Subjects With Any SAEs |
1; 3; 2; 2 | — |
| SECONDARY Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities |
0; 0; 0; 0; 98; 95 | — |
| SECONDARY Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading |
0; 0; 0; 0; 96; 97 | — |
| SECONDARY Neutralizing Antibody Titers Against RSV-A Subtype |
715.4; 831.9; 965.1; 311.6; 566.5; 732.1 | — |
| SECONDARY Neutralizing Antibody Titers Against RSV-B Subtype |
385.6; 392.1; 410.6; 340.2; 909.1; 1004.1 | — |
| SECONDARY Palivizumab Competing Antibody (PCA) Concentrations |
55.2; 69.0; 66.7; 6.4; 47.6; 57.9 | — |
| SECONDARY Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein |
32.9; 32.0; 33.5; 34.5; 32.9; 31.5 | — |
| SECONDARY Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV |
21; 11; 10; 9 | — |
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 performance of 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
- Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.
- 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 up to 90 days after vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
- Concurrently participating in the active phase of 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs, within 6 months prior to study vaccination, or planned administration until 90 days post-vaccination. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination.
- 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 neurological disorders or seizures.
- Family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of or current autoimmune disease
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
- Lymphoproliferative disorder or malignancy within previous 5 years.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Current alcohol and/or drug abuse.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- For subjects with acute disease and/or fever at the time of enrolment, Visit 1/Day 0 will be rescheduled within the allowed recruitment period.
- Body mass index (BMI) > 40 kg/m².
- Pregnant or lactating female.
- Planned move to a location that will prohibit participating in the trial until study conclusion.
- Any other condition that the investigator judges may interfere with study procedures or findings.
Data sourced from ClinicalTrials.gov (NCT02956837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.