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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00533741 |
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, TX area. The study will be done 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 days after each injection. During the 9 study visits, blood samples will be collected 7 times. Participants will be in the study for up to 211 days, including screening.
Condition | Intervention | Phase |
---|---|---|
SARS |
Drug: Aluminum hydroxide Drug: Placebo Biological: SARS-CoV |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study |
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-CoV) Vaccine Administered by the Intramuscular Route |
Estimated Enrollment: | 72 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1a: Experimental
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.
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Drug: Aluminum hydroxide
Adjuvant; administered with SARS-CoV vaccine dosages 2.0 and 5.0 mcg.
Drug: Placebo
Saline for injection.
Biological: SARS-CoV
Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and UV. Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
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2: Experimental
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.
|
Drug: Aluminum hydroxide
Adjuvant; administered with SARS-CoV vaccine dosages 2.0 and 5.0 mcg.
Drug: Placebo
Saline for injection.
Biological: SARS-CoV
Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and UV. Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
|
1b: Experimental
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.
|
Drug: Aluminum hydroxide
Adjuvant; administered with SARS-CoV vaccine dosages 2.0 and 5.0 mcg.
Drug: Placebo
Saline for injection.
Biological: SARS-CoV
Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and UV. Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
|
1c: Experimental
4 subjects randomized in a 1:3 fashion to receive a two dose regimen of placebo or vaccine with 10 mcg of antigen and no adjuvant.
|
Drug: Placebo
Saline for injection.
Biological: SARS-CoV
Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and UV. Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
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Severe acute respiratory disease (SARS) is a recently emerged infectious disease that was first recognized in Guangdong Province, China, in November of 2002. This protocol concerns Phase 1 clinical testing of an inactivated, purified SARS CoV vaccine administered with and without aluminum hydroxide 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, TX 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. All subjects in both Stages 1 and 2 will receive 2 injections of the assigned study material at Day 0 and 1 month, and will be followed for reactogenicity and immunogenicity for approximately 6 months. The primary study endpoints include: frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited AE/SAEs for 1 month after receipt of the 1st and 2nd doses of vaccine; frequency and description of SAEs for 5 months after receipt of the booster dose of vaccine; and frequency of significant increases serum antibody to SARS-CoV S protein in ELISA and in neutralization tests and increases in GMTs in sera collected 1 and 5 months after the booster dose of each vaccine, versus those collected before the 1st vaccination. The secondary endpoint will be the frequency of significant serum antibody increases and increases in GMTs in sera collected at 1 month (just before booster) versus those collected just before the 1st vaccination, as measured in neutralizing antibody tests and an ELISA against SARS-CoV S protein.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Are receiving psychiatric drugs*. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
* aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 07-0021 |
Study First Received: | September 20, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00533741 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
Severe Acute Respiratory Syndrome, Coronavirus, vaccine |
Severe Acute Respiratory Syndrome SARS Formaldehyde Aluminum Hydroxide |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Adjuvants, Immunologic Antacids Pharmacologic Actions |