NCT02115815

A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions.

Detailed description

A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort escalation study evaluating the safety and tolerability of a single ascending intramuscular dose of RSV sF or MEDI7510 or placebo. Approximately 146 participants will be enrolled at 3 US study centers and randomized in a 5:1 ratio by cohort as described below: Cohort 1: RSV sF 20 microgram (mcg) (n=20) or placebo (n=4) Cohort 1a: MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 2: RSV sF 50 mcg (n=20) or placebo (n=4) Cohort 2a: MEDI7510 (50 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 3: 80 mcg RSV sF (n=20) or placebo (n=4) Cohort 3a: MEDI7510 (80 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4)

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
BIOLOGICAL	RSV sF 20 mcg	Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICAL	MEDI7510 (20 mcg RSV sF)	Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICAL	RSV sF 50 mcg	Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICAL	MEDI7510 (50 mcg RSV sF)	Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICAL	RSV sF 80 mcg	Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICAL	MEDI7510 (80 mcg RSV sF)	Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-04-16
• Last updated: 2016-10-21
• Results posted: 2016-10-21

Locations

3 sites across 1 country: United States