A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): RSV F subunit 45 μg No adjuvant; RSV F subunit 45 μg Aluminum hydroxide adjuvant; RSV F subunit 45 μg MF59 adjuvant; RSV F subunit 90 μg No adjuvant; RSV F subunit 90 μg Aluminum hydroxide adjuvant; RSV F subunit 90 μg MF59 adjuvant; RSV F subunit 135 μg No adjuvant; RSV F subunit 135 μg Aluminum hydroxide adjuvant; RSV F subunit 135 μg MF59 adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): 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.
Other intervention name(s): Sterile saline 0.9%
Intervention MeSH terms: Aluminum Hydroxide; MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antibodies; Respiratory syncytial virus; Safety; Healthy adults; Immunogenicity