Clinical Trials Logo
  1. Home
  2. Respiratory Syncytial Virus
  3. NCT02472548

A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine

Respiratory Syncytial Virus Clinical Trial

Official title:
A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of Two Intramuscular Doses of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Containing Respiratory Syncytial Virus (RSV) SHe Antigen and a Novel Adjuvant DepoVaxTM, or SHe A Antigen Co-administered With Aluminum Hydroxide, or Placebo to Healthy Adults ≥50-64 Years of Age

Clinical Trial Summary

Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of age.

Clinical Trial Description

This is a phase 1, First in Humans, randomized (2:2:1) observer blind, controlled, dose ranging, multi-arm parallel-group clinical trial in healthy persons 50 to 64 years of age to assess the safety and immunogenicity of two dose levels of a novel vaccine formulation DPX-RSV(A) consisting of a synthetic Respiratory Syncytial Virus SHe antigen combined with a novel adjuvant DepoVaxTM, compared to the antigen combined with the commonly used adjuvant Aluminum hydroxide, and to a saline placebo control.

The study will evaluate two different doses of DPX-RSV(A) and two doses of the RSV SHe antigen with aluminum hydroxide (RSV(A)-Alum), and a placebo control. The study is randomized, controlled, and observer-blinded in order that allocation to treatment is concealed from the investigative team and the participant. The inclusion of comparator groups (a placebo control group and the RSV(A)-Alum) allows for estimation of the attributable risk of adverse events. Since the study vaccines are not identical in appearance, an unblinded study nurse who has no other role in the study will administer the study vaccines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02472548
Study type Interventional
Source Dalhousie University
Contact
Status Completed
Phase Phase 1
Start date May 2015
Completion date March 14, 2017
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04528719 - A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive Phase 1
Terminated NCT02508194 - A Study to Evaluate the Efficacy of MEDI7510 in Older Adults Phase 2
Active, not recruiting NCT06060457 - A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age Phase 3
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Completed NCT00100373 - RSV Challenge in Healthy Adults N/A
Completed NCT03524118 - Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) Phase 1/Phase 2
Active, not recruiting NCT05572658 - Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Recruiting NCT06067230 - A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults Phase 3
Completed NCT00246480 - RSV Disease in the Elderly
Active, not recruiting NCT06097299 - A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Phase 2
Completed NCT00889070 - Respiratory Events Among Premature Infants N/A
Unknown status NCT00613184 - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses N/A
Completed NCT05559905 - Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017) Phase 2
Active, not recruiting NCT05127434 - A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age Phase 2/Phase 3
Terminated NCT04978337 - A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Phase 2
Recruiting NCT06143046 - A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers Phase 2
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT01734668 - Sofia RSV FIA Field Study N/A
Completed NCT01562938 - MEDI-557 Adult Dosing Phase 1
Recruiting NCT06325657 - A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants Phase 3