Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
Brief Summary: The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially.

Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points.


Options:
A: Arm Label: RSV LID cp ΔM2-2 Vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV LID cp ΔM2-2 Vaccine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: RSV LID cp ΔM2-2 Vaccine; Assigned to Arm(s): RSV LID cp ΔM2-2 Vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: SynGEM low dose; Type: EXPERIMENTAL; Interventions: Biological: SynGEM | Arm Label: SynGEM high dose; Type: EXPERIMENTAL; Interventions: Biological: SynGEM | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: BIOLOGICAL; Name: SynGEM; Assigned to Arm(s): SynGEM high dose, SynGEM low dose | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): placebo
C: Arm Label: Group 1: DS-Cav1 (50 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 2: DS-Cav1 (50 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Arm Label: Group 3: DS-Cav1 (150 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 4: DS-Cav1 (150 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Arm Label: Group 5: DS-Cav1 (500 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 6:DS-Cav1 (500 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Intervention Type: BIOLOGICAL; Name: VRC-RSVRGP084-00-VP; Assigned to Arm(s): Group 1: DS-Cav1 (50 mcg), Group 2: DS-Cav1 (50 mcg) + alum, Group 3: DS-Cav1 (150 mcg), Group 4: DS-Cav1 (150 mcg) + alum, Group 5: DS-Cav1 (500 mcg), Group 6:DS-Cav1 (500 mcg) + alum | Intervention Type: OTHER; Name: Aluminum Hydroxide Suspension; Assigned to Arm(s): Group 2: DS-Cav1 (50 mcg) + alum, Group 4: DS-Cav1 (150 mcg) + alum, Group 6:DS-Cav1 (500 mcg) + alum
D: Arm Label: RSV cps2 Vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV cps2 Vaccine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo Vaccine | Intervention Type: BIOLOGICAL; Name: RSV cps2 Vaccine; Assigned to Arm(s): RSV cps2 Vaccine | Intervention Type: BIOLOGICAL; Name: Placebo Vaccine; Assigned to Arm(s): Placebo

Answer: B