SARS Coronavirus Vaccine (SARS-CoV)

NCT00533741 | Withdrawn Phase 1

• 1 other identifier: 07-0021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus (SARS-CoV)

Keywords

Severe Acute Respiratory Syndrome, Coronavirus, vaccine

Outcome Measures

Primary Outcomes (3)

• Frequency and description of serious adverse events (SAEs).

  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.

  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.

  1 month after receipt of the first and second doses of vaccine.

Secondary Outcomes (1)

• 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.

  Collected just before the first vaccination and at 1 month (just before booster).

Study Arms (4)

1c (10 mcg)

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; Biological: SARS-CoV

2 (dose comparison stage)

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; Drug: Placebo; Biological: SARS-CoV

1a (2.5 mcg)

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.

Drug: Aluminum hydroxide; Drug: Placebo; Biological: SARS-CoV

1b (5.0 mcg)

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; Drug: Placebo; Biological: SARS-CoV

Interventions

Aluminum hydroxide DRUG

Adjuvant; administered with SARS-CoV vaccine.

1a (2.5 mcg); 1b (5.0 mcg); 2 (dose comparison stage)

Placebo DRUG

Saline for injection.

1a (2.5 mcg); 1b (5.0 mcg); 1c (10 mcg); 2 (dose comparison stage)

SARS-CoV BIOLOGICAL

Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and ultraviolet light (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.

1a (2.5 mcg); 1b (5.0 mcg); 1c (10 mcg); 2 (dose comparison stage)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and communicate in written and spoken English.
• Judged to be able to provide informed consent and has signed informed consent form prior to study participation.
• Male or female between 18 and 40 years of age.
• Females of childbearing potential agree to practice adequate contraception for the entire study period.
• Good general health as confirmed by medical history, history-directed physical examination, and laboratory assessments within normal ranges established by Baylor College of Medicine.
• Availability for follow-up for six months after the first vaccination.
• Willing and able to comply with protocol requirements.

You may not qualify if:

• Clinically significant medical disorder found by medical history or physical exam.
• History of anaphylaxis or other significant adverse event following immunization.
• History of or planned exposure to small mammalian animals that are from Asia, or were previously housed with Asian counterparts.
• Pregnant or lactating female.
• Acute illness (cough, congestion, malaise, diarrhea, feverishness and/or oral temperature \> 99.5 degrees Fahrenheit, etc.) within a week of planned vaccination.
• Use of an immunosuppressive or immunomodulatory drug such as greater than 5 mg/day of prednisone orally, or greater than 800 mcg/day of inhaled beclomethasone for 2 or more consecutive weeks within 3 months prior to the first vaccination.
• History of or current substance abuse, including alcohol (e.g., greater than or equal to 4 six-packs of beer or equivalent per week regularly).
• History of receiving blood or blood products in the previous three months, or anticipated over the six month study period.
• Vaccination with a live vaccine within 30 days of study vaccination, or a non-replicating, inactivated or subunit vaccine within 14 days of study vaccination, or planned during the study.
• Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg).
• Positive serology for severe acute respiratory disease (SARS) S protein if testing is done.
• Use of any investigational or unregistered drug or vaccine within 30 days before the first study vaccination, or planned use during the study.
• Autoimmune disease (e.g., lupus, rheumatoid arthritis), malignancy or tumor.
• Bleeding disorder by history, or thrombocytopenia.
• Diagnosis of schizophrenia, bipolar disease or other major psychiatric disorder.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 3, 2012

Record last verified: 2010-03

Locations

US (1)