Trial Outcomes & Findings for A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults (NCT NCT02298179)

Last Updated: 2018-08-13

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

288 participants

Primary outcome timeframe

At Day 57

Results posted on

2018-08-13

Participant Flow

Subjects were enrolled from one site in Belgium.

All subjects enrolled were included in the trial.

Participant milestones

Participant milestones
Measure	RSV F 45 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with no adjuvant.	RSV F 45 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with aluminum hydroxide adjuvant.	RSV F 45 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with MF59 adjuvant.	Placebo 1 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 1.	RSV F 90 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with no adjuvant.	RSV F 90 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with aluminum hydroxide adjuvant.	RSV F 90 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with MF59 adjuvant.	Placebo 2 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 2.	RSV F 135 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with no adjuvant.	RSV F 135 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with aluminum hydroxide adjuvant.	RSV F 135 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with MF59 adjuvant.	Placebo 3 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 3.
Overall Study STARTED	24	24	24	24	24	24	24	24	24	24	24	24
Overall Study COMPLETED	24	24	23	24	24	24	24	23	24	24	24	24
Overall Study NOT COMPLETED	0	0	1	0	0	0	0	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV F 45 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with no adjuvant.	RSV F 45 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with aluminum hydroxide adjuvant.	RSV F 45 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with MF59 adjuvant.	Placebo 1 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 1.	RSV F 90 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with no adjuvant.	RSV F 90 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with aluminum hydroxide adjuvant.	RSV F 90 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with MF59 adjuvant.	Placebo 2 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 2.	RSV F 135 No Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with no adjuvant.	RSV F 135 Alum Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with aluminum hydroxide adjuvant.	RSV F 135 MF59 Adj Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with MF59 adjuvant.	Placebo 3 Group Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 3.
Overall Study Lost to Follow-up	0	0	1	0	0	0	0	1	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV F 45 No Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with no adjuvant.	RSV F 45 Alum Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with aluminum hydroxide adjuvant.	RSV F 45 MF59 Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with MF59 adjuvant.	Placebo 1 Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 1.	RSV F 90 No Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with no adjuvant.	RSV F 90 Alum Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with aluminum hydroxide adjuvant.	RSV F 90 MF59 Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with MF59 adjuvant.	Placebo 2 Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 2.	RSV F 135 No Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with no adjuvant.	RSV F 135 Alum Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with aluminum hydroxide adjuvant.	RSV F 135 MF59 Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with MF59 adjuvant.	Placebo 3 Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 3.	Total n=288 Participants Total of all reporting groups
Age, Continuous	28.6 Years STANDARD_DEVIATION 6.8 • n=5 Participants	27.7 Years STANDARD_DEVIATION 6.55 • n=7 Participants	30.2 Years STANDARD_DEVIATION 7.9 • n=5 Participants	30.3 Years STANDARD_DEVIATION 7.62 • n=4 Participants	30.4 Years STANDARD_DEVIATION 8.31 • n=21 Participants	31.2 Years STANDARD_DEVIATION 7.47 • n=8 Participants	27.6 Years STANDARD_DEVIATION 6.84 • n=8 Participants	28 Years STANDARD_DEVIATION 7.3 • n=24 Participants	28.3 Years STANDARD_DEVIATION 6.8 • n=42 Participants	29.5 Years STANDARD_DEVIATION 6.98 • n=42 Participants	32.9 Years STANDARD_DEVIATION 8.46 • n=42 Participants	27.9 Years STANDARD_DEVIATION 5.86 • n=42 Participants	29.13 Years STANDARD_DEVIATION 7.24 • n=36 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	16 Participants n=21 Participants	18 Participants n=8 Participants	15 Participants n=8 Participants	14 Participants n=24 Participants	22 Participants n=42 Participants	18 Participants n=42 Participants	20 Participants n=42 Participants	20 Participants n=42 Participants	216 Participants n=36 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	6 Participants n=8 Participants	9 Participants n=8 Participants	10 Participants n=24 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	72 Participants n=36 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized WHITE	23 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	24 Participants n=4 Participants	24 Participants n=21 Participants	24 Participants n=8 Participants	24 Participants n=8 Participants	23 Participants n=24 Participants	24 Participants n=42 Participants	24 Participants n=42 Participants	24 Participants n=42 Participants	24 Participants n=42 Participants	284 Participants n=36 Participants
Race/Ethnicity, Customized NOT SPECIFIED	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: At Day 57

Population: The analysis was based on the Per-Protocol Set (PPS), which included all subjects in the Full Analysis Set (FAS) Immunogenicity population who were not excluded due to the reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 57.

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).

Outcome measures

Outcome measures
Measure	RSV F 45 No Adj Group n=22 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with no adjuvant.	RSV F 45 Alum Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with aluminum hydroxide adjuvant.	RSV F 45 MF59 Adj Group n=22 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with MF59 adjuvant.	Placebo 1 Group n=23 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 1.	RSV F 90 No Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with no adjuvant.	RSV F 90 Alum Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with aluminum hydroxide adjuvant.	RSV F 90 MF59 Adj Group n=22 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with MF59 adjuvant.	Placebo 2 Group n=23 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 2.	RSV F 135 No Adj Group n=23 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with no adjuvant.	RSV F 135 Alum Adj Group n=22 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with aluminum hydroxide adjuvant.	RSV F 135 MF59 Adj Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with MF59 adjuvant.	Placebo 3 Group n=24 Participants Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 3.
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers	864 Titers Interval 692.0 to 1077.0	914 Titers Interval 738.0 to 1134.0	843 Titers Interval 673.0 to 1057.0	234 Titers Interval 169.0 to 324.0	844 Titers Interval 665.0 to 1072.0	746 Titers Interval 587.0 to 947.0	944 Titers Interval 735.0 to 1213.0	253 Titers Interval 189.0 to 337.0	903 Titers Interval 729.0 to 1119.0	1212 Titers Interval 974.0 to 1509.0	1316 Titers Interval 1066.0 to 1623.0	254 Titers Interval 183.0 to 354.0

PRIMARY outcome

Timeframe: At Day 57

Population: The analysis was based on PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and and for whom immunogenicity results collected from Day 1 (baseline) up to Day 57 were available at Day 1 and Day 57.

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).