*nih.life
			Clinical Trial Sponsors: National Institute of Allergy and Infectious Diseases (NIAID)

  Source:		NCT00533741


    		SARS Coronavirus Vaccine (SARS-CoV)
     
			Withdrawn

			First Update September 20, 2007
			Last Update November 29, 2012

			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 Description
			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
			responses to each vaccine 1 month after a
			single dose. This is a single center, Phase I,
			out-patient study of the reactogenicity (tolerability
			and safety) and immunogenicity of escalating
			doses of an inactivated SARS-CoV vaccine
			with and without aluminum hydroxide as an
			adjuvant. Each vaccine will be injected as
			primary and booster vaccinations a month
			apart in the subject's non-dominant deltoid
			muscle. Participants will include 72 healthy
			males or non-pregnant, non-lactating females,
			18-40 years old from the Houston, Texas area.
			The study will be conducted at Baylor College of Medicine
			in 2 sequential stages. This study consists of
			a preliminary dose-escalation stage (1.a, 1.b,
			and 1.c) followed by a dose comparison stage
			(2) as follows: Stage 1a (2.5 mcg), 7 subjects
			randomized in a 1:3:3 fashion to receive a 2
			dose regimen of placebo, vaccine containing
			2.5 mcg of antigen and no adjuvant, or 2.5
			mcg of antigen and Alum adjuvant; Stage 1b
			(5.0 mcg), 7 subjects randomized in a 1:3:3
			fashion to receive a 2 dose regimen of placebo,
			vaccine containing 5.0 mcg of antigen and no
			adjuvant, or 5.0 mcg of antigen and Alum
			adjuvant; Stage 1c (10.0 mcg), 4 subjects
			randomized in a 1:3 fashion to receive a 2 dose
			regimen of placebo or vaccine with 10 mcg
			of antigen and no adjuvant; Stage 2, 54 subjects
			(9 per vaccine group) randomized 1:1:1:1:1:1
			to receive vaccines containing, 2.5, 5.0, or
			10.0 mcg of antigen without adjuvant, or 2.5
			or 5.0 mcg of antigen with Alum, or placebo.

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