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| ID | Type | Description | Link |
|---|---|---|---|
| HSRRB A-13513 |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
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The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.
This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
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| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant | Experimental | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
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| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant | Experimental | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine | Biological | The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination | 7 day f/u period after each vaccination |
| Safety: Adverse Event Type Summarized by Dose | Adverse events summarized by type and dose | 7 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks to Serconversion | Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barnett Gibbs, MD | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Paul B Keiser | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research, Clinical Trials Center | Silver Spring | Maryland | 20910 | United States |
WRAIR
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34 subjects were enrolled to be randomized into 1 of 3 cohorts at the WRAIR CTC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). Two dosage levels were investigated: 25 µg with and without adjuvant and 50 µg of protein without adjuvant. Each dose was given intramuscularly at 0, 6, and 24 weeks.
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The first 2 cohorts were double blind, and the third cohort was not blinded. The investigator preparing the vaccine did not participate in making subsequent study assessments or subject evaluability decisions. After the vaccine was prepared, the subject's identification number was placed onto the drawn syringe. All information, vaccine dose, adjuvant dose (if applicable), and subject identification number, was recorded on the Vaccine Administration Code Form. The form was placed in an envelope. The envelope was sealed and placed in a secured location. The medical personnel who vaccinated the subjects witnessed the dilution and placement of the subject identification number on the syringe. This staff member vaccinated the subject but did not participate in subsequent study visits or the evaluation. The blind was broken after verification that all serology testing was completed.
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| 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine | Biological | The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
|
| 26 weeks |
| Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion | 26 weeks |
| FG001 | 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| FG002 | 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| BG001 | 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| BG002 | 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | There is discrepancy in the demographic data within the Final Clinical Study Report (FCSR). Number of subject for 1) 25ug states total number of 12 subjects analyzed, but the race data indicates 13 subjects. Number of subjects for 2) 25ug states total number of 11 subjects analyzed, but the race data indicates 12 subjects analyzed. Data must me entered as indicated in the FCSR. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination | Posted | Number | AEs | 7 day f/u period after each vaccination |
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| Primary | Safety: Adverse Event Type Summarized by Dose | Adverse events summarized by type and dose | Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage | Posted | Number | Number of AEs | 7 days after each vaccination |
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| Secondary | Weeks to Serconversion | Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development. | Number analyzed are subjects that seroconverted | Posted | Mean | Standard Deviation | Weeks | 26 weeks |
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| Secondary | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion | Number of participants analyzed represents subjects who experienced increases from baseline | Posted | Number | % of subjects | 26 weeks |
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7 days after each vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. | 0 | 12 | 0 | 12 | 12 | 12 |
| EG001 | 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. | 0 | 11 | 0 | 11 | 11 | 11 |
| EG002 | 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. | 0 | 11 | 0 | 11 | 11 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tenderness | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain lifting arm | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Warmth | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Induration | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Bruise | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypochromasia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Lyme disease | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chest injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Neck injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Blood bilirubin inconjugated increated | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Haptoglobin increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Glycosuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul B. Keiser | WRAIR | 866-856-3259 | clinical1@na.amedd.army.mil |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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| Male |
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| Black or African American |
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| Hispanic or Latino |
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| Asian |
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| Title | Measurements |
|---|---|
|
| Solicited: Not related to study drug |
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| Solicited: Related to study drug |
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| Unsolicited: Number of subjects with atleast 1 AE |
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| Unsolicited: Mild |
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| Unsolicited: Moderate |
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| Unsolicited: Severe |
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| Unsolicited: Not related to study drug |
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| Unsolicited: Related to study drug |
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| Units | Counts |
|---|
| Participants |
|
|
| OG002 | 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
|
|
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant |
Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks. 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks. |
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