SARSPhase 1NCT01376765
Phase I Dose Escalation SARS-CoV Recombinant S Protein, With and Without Adjuvant, Vaccine Study
A Phase 1 study testing Aluminum hydroxide adjuvant (Alhydrogel®) and Recombinant S protein SARS vaccine in people with SARS, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study. Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by Protein Sciences Corporation), two doses… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS
- What is being tested?
- Aluminum hydroxide adjuvant (Alhydrogel®) and Recombinant S protein SARS vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or nonpregnant females between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have not been postmenopausal for >/=1 year) must agree to practice adequate contraception for the 30-day period before vaccination through 90 days after the second vaccination. Acceptable birth control methods for the purposes of this study may include, but are not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, and intrauterine devices, and licensed hormonal methods.
- In good health, as judged by the investigator and determined by vital signs [temperature < 38 degrees C, heart rate </= 100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </= 90 mmHg and >/= 60 mm Hg, respiratory rate >/= 12 breath per minute and < 17 breaths per minutes (see toxicity table in Section 9.1.2)], medical history and a targeted physical examination, as indicated, based on medical history.
- Screening laboratory values must be within normal limits. These include blood hemoglobin, white blood cell (WBC) count, eosinophils, platelets, absolute eosinophil, neutrophil, and lymphocyte cell counts, creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT), bilirubin (total), glucose (random), and urinalysis (proteinuria and hematuria). See toxicity table in Section 9.1.3.2. Note: creatinine values lower than the normal are acceptable.
- Able to understand and comply with planned study procedures.
- Willing to be available for all study-required procedures, visits and calls for the duration of the study.
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- Provide written informed consent before initiation of any study procedures and be available for all study visits.
- Negative for IgG antibodies to S protein of Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) measured by ELISA.
- Negative for antibodies to Human Immunodeficiency Virus (HIV) and hepatitis C virus and for hepatitis B surface antigen.
- Negative for IgG antibodies to S protein of Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) measured by ELISA.
- Negative for antibodies to Human Immunodeficiency Virus (HIV) and hepatitis C virus and for hepatitis B surface antigen.
Who cannot join
- A known allergy to components of the vaccine.
- A positive serum or urine pregnancy test within 24 hr prior to vaccination (if female of childbearing potential as defined in Inclusion Criterion 2), women who are planning to become pregnant from 30 days prior to entering the study until 90 days after the final study vaccination, or women who are breastfeeding.
- Immunosuppression as result of underlying illness or treatment or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- An active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. Nonactive neoplastic disease is defined as no neoplastic disease or treatment for neoplastic disease within the past 5 years.
- A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarteritis, thyroiditis, etc).
- Used an immunosuppressive or immunomodulatory drug such as >0.5 mg/kg/day or >/=20 mg total dose/day of prednisone orally or >800 mcg of inhaled beclomethasone for 2 or more consecutive weeks within 6 months prior to the 1st vaccination. (Nasal and topical steroids are allowed.)
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- A known human immunodeficiency virus (HIV) infection, or active hepatitis B, or hepatitis C virus infection.
- A diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis in the past 3 years.
- Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others in the past 3 years.
- Receiving psychiatric drugs listed below*. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to be enrolled in the study.
- aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate, or lithium citrate.
- A history of receiving immunoglobulin or other blood product within the previous 3 months before vaccination.
- Received or plan to receive any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks of each vaccination,
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses or is not generally seen in healthy, normal subjects. (This includes, but is not limited to, known cardiac disease, pulmonary disease, liver disease, renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients.)
- A history of severe reactions following immunization with vaccines.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month before vaccination in this study or expect to receive an experimental agent during the 24-month study period.
- Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study.
- A history of alcohol or drug abuse during the previous 1 year; for example, daily excessive alcohol use or frequent binge drinking as determined by the investigator, or chronic marijuana abuse or any other illicit drug use.
- Plans to travel outside North America in the time between the 1st vaccination and 56 days following the first vaccination or have plans to travel to Southeast Asia during their entire study participation.
- Body temperature >/=100.4 F (>/=38.0 C) or acute illness within 3 days before vaccination (subject may be rescheduled).
- Planned or have had a known exposure to the Himalayan palm civet, raccoon dog of Southeast Asia, or Chinese horseshoe bat, including bats that have been shipped from Southeast Asia or that were previously housed with Southeast Asian counterparts.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3026
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, 52242-1009
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: Phase I, Double-Blinded, Placebo-Controlled, Dose- Escalation Study of the Safety and Immunogenicity of Recombinant SARS-CoV deltaTM S Protein Vaccine Formulated With and Without Alhydrogel® in Healthy Adults When Administered by the Intramuscular Route
This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study. Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years of age will be enrolled.
Read the detailed description
This is a Phase 1,multi-center, randomized, double-blinded, placebo-controlled, outpatient study in healthy male and nonpregnant female subjects 18 to 40 years of age, inclusive. Three dosing cohorts to investigate the safety, reactogenicity, and immunogenicity of Recombinant S protein Severe Acute Respiratory Syndrome (SARS) vaccine, with and without aluminum hydroxide adjuvant manufactured by Protein Sciences Corporation, administered intramuscularly on Days 0 and 28 at a dose of 5, 15, or 45 mcg; controls will receive the diluents/placebo without vaccine. Approximately 84 subjects are expected to be enrolled. All subjects will receive 2 doses of their assigned treatment via IM injection approximately 28 days apart, followed by assessments at 6, 12, 15, 18, 21 and 24 months after the second dose.
- Conditions
- SARS
- Being tested
- Aluminum hydroxide adjuvant (Alhydrogel®), Phosphate buffered saline Placebo, Recombinant S protein SARS vaccine
- Keywords
- SARS, coronavirus, vaccine, adjuvant, Alhydrogel®, severe acute respiratory syndrome
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum hydroxide adjuvant (Alhydrogel®)Drug
Aluminum hydroxide adjuvant (Alhydrogel®);given with SARS vaccine; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine with adjuvant at 45 micrograms per dose
Phosphate buffered saline PlaceboOther
Phosphate buffered saline Placebo; 2 intramuscular doses, 28 days apart. Cohort 1: 4 subjects given placebo at 5 micrograms per dose; Cohort 2: 4 subjects given placebo at 15 micrograms per dose; Cohort 3: 4 subjects given placebo at 45 micrograms per dose
Recombinant S protein SARS vaccineBiological
Recombinant S protein severe acute respiratory syndrome (SARS) vaccine given with adjuvant or without adjuvant; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine only or vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine only or vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine only or vaccine with adjuvant at 45 micrograms per dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Recombinant S protein severe acute respiratory syndrome (SARS) vaccine received with aluminum hydroxide adjuvant (Alhydrogel®), without adjuvant, or placebo in 2 intramuscular doses, 28 days apart, at 5 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine {(SARS vaccine with aluminum hydroxide adjuvant (Alhydrogel®)}; 4 subjects receive placebo. Receives: Drug: Aluminum hydroxide adjuvant (Alhydrogel®); Other: Phosphate buffered saline Placebo; Biological: Recombinant S protein SARS vaccine |
| Cohort 3 | Experimental | SARS vaccine with adjuvant, without adjuvant, or placebo; l in 2 intramuscular doses, 28 days apart, at 45 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine (SARS vaccine with adjuvant); 4 subjects receive placebo. Receives: Drug: Aluminum hydroxide adjuvant (Alhydrogel®); Other: Phosphate buffered saline Placebo; Biological: Recombinant S protein SARS vaccine |
| Cohort 2 | Experimental | SARS vaccine with adjuvant, without adjuvant, or placebo in 2 intramuscular doses, 28 days apart, at 15 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine (SARS vaccine with adjuvant) 4 subjects receive placebo. Receives: Drug: Aluminum hydroxide adjuvant (Alhydrogel®); Other: Phosphate buffered saline Placebo; Biological: Recombinant S protein SARS vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35)
Measured: 8 days after vaccination (Days 0-7 and Days 28-35)
Incidence of vaccine-related serious adverse events (SAEs) throughout the duration of the study.
Measured: Day 0 to Day 758
Occurrence of laboratory abnormalities at 8 days after vaccination (Days 8 and 36)
Measured: 8 days after vaccination (Days 8 and 36)
Secondary outcomes (4)
Immunogenicity: Proportion of subjects achieving a detectable serum neutralizing antibody titer against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (approximately Day 56)
Measured: 28 days after receipt of the second dose of vaccine (approximately Day 56)
Immunogenicity: GMT of neutralizing antibody titers against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (Day 56). Measurement will include the Day 56 GMT and the mean fold change (GMT ratio Day 56:Day 0)
Measured: 28 days after receipt of the second dose of vaccine (Day 56)
Comparison of rates of unsolicited AEs related to vaccine for all subjects between treatment groups and in the combined cohorts receiving vaccine with aluminum hydroxide adjuvant compared with those receiving vaccine with no adjuvant.
Measured: intervals from Days 0-7, Days 0-28, Days 8-28, Days 0-56, Days 29-36, and Days 29-56.
Immunogenicity: Geometric Mean Titer (GMT) of antibody titers (IgG ELISA for S protein of SARS-CoV) 28 days after receipt of the second dose of vaccine (Day 56) at each vaccine dose level, with and without adjuvant
Measured: 28 days after receipt of the second dose of vaccine (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARSStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376765
- Sponsor's protocol ID
- 09-0100
- Status last verified
- Apr 2012
- First submitted
- 16 Jun 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Double-Blinded, Placebo-Controlled, Dose- Escalation Study of the Safety and Immunogenicity of Recombinant SARS-CoV deltaTM S Protein Vaccine Formulated With and Without Alhydrogel® in Healthy Adults When Administered by the Intramuscular Route
- ClinicalTrials.gov ID
- NCT01376765
- Acronym / sponsor ID
- 09-0100
- Conditions
- SARS
- Keywords
- SARS, coronavirus, vaccine, adjuvant, Alhydrogel®, severe acute respiratory syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study. Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose. PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years of age will be enrolled.
Detailed description
This is a Phase 1,multi-center, randomized, double-blinded, placebo-controlled, outpatient study in healthy male and nonpregnant female subjects 18 to 40 years of age, inclusive. Three dosing cohorts to investigate the safety, reactogenicity, and immunogenicity of Recombinant S protein Severe Acute Respiratory Syndrome (SARS) vaccine, with and without aluminum hydroxide adjuvant manufactured by Protein Sciences Corporation, administered intramuscularly on Days 0 and 28 at a dose of 5, 15, or 45 mcg; controls will receive the diluents/placebo without vaccine. Approximately 84 subjects are expected to be enrolled. All subjects will receive 2 doses of their assigned treatment via IM injection approximately 28 days apart, followed by assessments at 6, 12, 15, 18, 21 and 24 months after the second dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aluminum hydroxide adjuvant (Alhydrogel®), Other: Phosphate buffered saline Placebo, Biological: Recombinant S protein SARS vaccineRecombinant S protein severe acute respiratory syndrome (SARS) vaccine received with aluminum hydroxide adjuvant (Alhydrogel®), without adjuvant, or placebo in 2 intramuscular doses, 28 days apart, at 5 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine {(SARS vaccine with aluminum hydroxide adjuvant (Alhydrogel®)}; 4 subjects receive placebo. |
| Cohort 3 | Experimental | Drug: Aluminum hydroxide adjuvant (Alhydrogel®), Other: Phosphate buffered saline Placebo, Biological: Recombinant S protein SARS vaccineSARS vaccine with adjuvant, without adjuvant, or placebo; l in 2 intramuscular doses, 28 days apart, at 45 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine (SARS vaccine with adjuvant); 4 subjects receive placebo. |
| Cohort 2 | Experimental | Drug: Aluminum hydroxide adjuvant (Alhydrogel®), Other: Phosphate buffered saline Placebo, Biological: Recombinant S protein SARS vaccineSARS vaccine with adjuvant, without adjuvant, or placebo in 2 intramuscular doses, 28 days apart, at 15 micrograms per dose; 12 subjects receive unadjuvanted vaccine (SARS vaccine alone); 12 subjects receive adjuvanted vaccine (SARS vaccine with adjuvant) 4 subjects receive placebo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Males or nonpregnant females between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have not been postmenopausal for >/=1 year) must agree to practice adequate contraception for the 30-day period before vaccination through 90 days after the second vaccination. Acceptable birth control methods for the purposes of this study may include, but are not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, and intrauterine devices, and licensed hormonal methods.
- In good health, as judged by the investigator and determined by vital signs [temperature < 38 degrees C, heart rate </= 100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </= 90 mmHg and >/= 60 mm Hg, respiratory rate >/= 12 breath per minute and < 17 breaths per minutes (see toxicity table in Section 9.1.2)], medical history and a targeted physical examination, as indicated, based on medical history.
- Screening laboratory values must be within normal limits. These include blood hemoglobin, white blood cell (WBC) count, eosinophils, platelets, absolute eosinophil, neutrophil, and lymphocyte cell counts, creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT), bilirubin (total), glucose (random), and urinalysis (proteinuria and hematuria). See toxicity table in Section 9.1.3.2. Note: creatinine values lower than the normal are acceptable.
- Able to understand and comply with planned study procedures.
Key exclusion criteria (21 listed)
- A known allergy to components of the vaccine.
- A positive serum or urine pregnancy test within 24 hr prior to vaccination (if female of childbearing potential as defined in Inclusion Criterion 2), women who are planning to become pregnant from 30 days prior to entering the study until 90 days after the final study vaccination, or women who are breastfeeding.
- Immunosuppression as result of underlying illness or treatment or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- An active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. Nonactive neoplastic disease is defined as no neoplastic disease or treatment for neoplastic disease within the past 5 years.
- A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarteritis, thyroiditis, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aluminum hydroxide adjuvant (Alhydrogel®)Aluminum hydroxide adjuvant (Alhydrogel®);given with SARS vaccine; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine with adjuvant at 45 micrograms per dose | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Phosphate buffered saline PlaceboPhosphate buffered saline Placebo; 2 intramuscular doses, 28 days apart. Cohort 1: 4 subjects given placebo at 5 micrograms per dose; Cohort 2: 4 subjects given placebo at 15 micrograms per dose; Cohort 3: 4 subjects given placebo at 45 micrograms per dose | Other | Cohort 1, Cohort 2, Cohort 3 |
| Recombinant S protein SARS vaccineRecombinant S protein severe acute respiratory syndrome (SARS) vaccine given with adjuvant or without adjuvant; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine only or vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine only or vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine only or vaccine with adjuvant at 45 micrograms per dose | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35)
Time frame: 8 days after vaccination (Days 0-7 and Days 28-35)
Incidence of vaccine-related serious adverse events (SAEs) throughout the duration of the study.
Time frame: Day 0 to Day 758
Occurrence of laboratory abnormalities at 8 days after vaccination (Days 8 and 36)
Time frame: 8 days after vaccination (Days 8 and 36)
4 secondary outcomes
Immunogenicity: Proportion of subjects achieving a detectable serum neutralizing antibody titer against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (approximately Day 56)
Time frame: 28 days after receipt of the second dose of vaccine (approximately Day 56)
Immunogenicity: GMT of neutralizing antibody titers against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (Day 56). Measurement will include the Day 56 GMT and the mean fold change (GMT ratio Day 56:Day 0)
Time frame: 28 days after receipt of the second dose of vaccine (Day 56)
Comparison of rates of unsolicited AEs related to vaccine for all subjects between treatment groups and in the combined cohorts receiving vaccine with aluminum hydroxide adjuvant compared with those receiving vaccine with no adjuvant.
Time frame: intervals from Days 0-7, Days 0-28, Days 8-28, Days 0-56, Days 29-36, and Days 29-56.
Immunogenicity: Geometric Mean Titer (GMT) of antibody titers (IgG ELISA for S protein of SARS-CoV) 28 days after receipt of the second dose of vaccine (Day 56) at each vaccine dose level, with and without adjuvant
Time frame: 28 days after receipt of the second dose of vaccine (Day 56)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aluminum hydroxide adjuvant (Alhydrogel®) and Recombinant S protein SARS vaccine in people with SARS, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35) (time frame: 8 days after vaccination (Days 0-7 and Days 28-35)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.