The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
288
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
GSK Investigational Site
Ghent, Belgium
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
Time frame: At Day 57
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
Time frame: At Day 57
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Time frame: Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (6 hour) through Day 3 after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 4 through Day 7 after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (6 hours) through Day 3 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 4 through Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
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.
Time frame: From Day 1 to Day 28 after each vaccination
Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination. Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.
Time frame: From study start (Day 1) until study completion (Day 394)
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).
Time frame: At Day 1, Day 29 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).
Time frame: At Day 29 and at Day 181
Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).
Time frame: At Day 29, Day 57 and Day 181
Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).
Time frame: At Day 1, Day 29, Day 57 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 \[28 days after the first dose\], Day 57 \[28 days after the second dose\], and Day 181 \[six months after the first dose\]).
Time frame: At Day 29, Day 57 and Day 181
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Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).
Time frame: At Day 29, Day 57 and Day 181
Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N
Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.
Time frame: At Day 1, Day 29, Day 57 and Day 181