Clinical Trial: SARS Coronavirus Vaccine (SARS-CoV)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase I, Double-Blinded, Placebo-Controlled Dosage Escalation Study of the Safety and Immunogenicity of Adjuvanted and Non-Adjuvanted Inactivated SARS Coronavirus (SARS-Co

Brief Summary: Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory (breathing) system. The purpose of this study is to evaluate the safety and protective (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An adjuvant is a substance that may be added to a vaccine to improve the immune response so that less of the vaccine may need to be given. Study participants will include 72 volunteers, ages 18-40, living in the Houston, Texas area. The study will take place at Baylor College of Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to look like the study vaccine but contains no medication) given 1 month apart. Participants will fill out a memory aid (diary) to document daily temperature and illness signs and symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples will be collected. Participants will be in the study for up to 211 days, including screening.

Detailed Summary: Severe acute respiratory disease (SARS) is a recently emerged infectious disease that was first recognized in Guangdong Province, China, in November of 2002. Efforts to prevent the spread of this virus stopped the epidemic in July, 2003, but over 8,000 cases had occurred and almost 800 people died. A new virus, a coronavirus, was shown to be the cause and it is believed to be a virus of bats that infected some animals that, in turn, infected people and they gave it to other people. While it is unlikely to again become epidemic, the virus is thought to be a risk for spread to humans if it was released intentionally by a terrorist group. For that reason, the U.S. government is developing vaccines and drugs for use if spread should occur again. This study will test the safety and protective responses to a vaccine against SARS made by a vaccine company for this study. This protocol concerns Phase I clinical testing of an inactivated, purified SARS Coronavirus (CoV) vaccine administered with and without aluminum hydroxide (Alum) adjuvant. The rationale for development of vaccines against SARS-CoV is to provide a means of control in the event a new SARS-CoV epidemic occurs or there is a deliberate release of the virus. Inactivated SARS-CoV vaccine has been shown to induce neutralizing antibodies that block binding of the virus to its receptor, ACE2. The primary objectives of the study are to assess: reactogenicity of escalating doses of adjuvanted and non-adjuvanted, inactivated SARS-CoV vaccine among healthy young adult subjects given their first intramuscular (IM) vaccinations with this vaccine; reactogenicity of a repeat IM administration of the same material to healthy young adult subjects one month later; and development and persistence of immune responses to escalating doses of adjuvanted and non-adjuvanted, inactivated SARS-CoV vaccine 1 and 5 months after the second ("booster") vaccination. The secondary objective of this study is to assess immune respon
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Frequency and description of serious adverse events (SAEs). [ Time Frame: 5 months after receipt of the booster dose of vaccine. ]
  • Frequency of significant increases in serum antibody to CoV S protein in Enzyme Linked Immunosorbent Assay (ELISA) and in neutralization tests, and increases in Geometric Mean Titers (GMT)s in sera. [ Time Frame: Screening, 1 and 5 months after the booster dose of vaccine. ]
  • Frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited adverse events (AE) / SAEs. [ Time Frame: 1 month after receipt of the first and second doses of vaccine. ]


Original Primary Outcome:

Current Secondary Outcome: Frequency of significant serum antibody increases and increases in Geometric Mean Titers (GMT)s, as measured in neutralizing antibody tests and an ELISA against SARS-CoV S protein. [ Time Frame: Collected just before the first vaccination and at 1 month (just before booster). ]

Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: September 20, 2007
Date Started:
Date Completion: January 2012
Last Updated: November 29, 2012
Last Verified: March 2010