Multiple Sclerosis, Relapsing-RemittingPhase 3NCT02545868
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
A Phase 3 study testing 23-PPV, 13-PCV Booster and Influenza Vaccine in people with Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 22 sites in 2 countries.
Trial summary
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- 23-PPV, 13-PCV Booster and Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 27 Oct 2015to 21 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of RMS in accordance with the revised McDonald criteria
- Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
- Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
- For sexually active female participants of reproductive potential, use of reliable means of contraception
Who cannot join
- Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
- Known presence of other neurologic disorders
- Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
University of New Mexico
Albuquerque, New Mexico, 87131
Mercy Hospital St. Louis / Mercy Clinic Neurology
Chesterfield, Missouri, 63017
Ohio Health Research Institute Grant Medical Center
Columbus, Ohio, 43214
Neurology Clinic PC
Cordova, Tennessee, 38018
North Central Neurology Associates
Cullman, Alabama, 35058
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
Fullerton Neurology and Headache Center
Fullerton, California, 92835
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Neurology Associates PA
Hickory, North Carolina, 28602
Scripps Clinic
La Jolla, California, 92037
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, 89106
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami, Florida, 33136
Central Texas Neurology Consultants
Round Rock, Texas, 78681
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103
Swedish Medical Center
Seattle, Washington, 98104-1360
Staten Island Univ Hospital
Staten Island, New York, 10306
University of South Florida
Tampa, Florida, 33612
Territory Neurology and Research Institute
Tucson, Arizona, 85704
MDH Research LLC
Westerville, Ohio, 43082
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, V6T 2B5
About this study
Official title: A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- 23-PPV, 13-PCV Booster, Influenza Vaccine, KLH, OCR
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-PPVBiological
The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).
13-PCV BoosterBiological
The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).
Influenza VaccineBiological
The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).
KLHBiological
KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).
OCRDrug
Also called RO4964913, PRO70769, rhuMAb 2H7
OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.
TT VaccineBiological
The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
| Study group | Role | What they receive |
|---|---|---|
| Group A: OCR + Vaccines | Experimental | Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period. Receives: Biological: 23-PPV; Biological: 13-PCV Booster; Biological: Influenza Vaccine; Biological: KLH; Drug: OCR; Biological: TT Vaccine |
| Group B: Vaccines (Optional OCR in Extension) | Other | Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. Receives: Biological: 23-PPV; Biological: Influenza Vaccine; Biological: KLH; Drug: OCR; Biological: TT Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Measured: 8 weeks after TT vaccine
Secondary outcomes (31)
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Measured: 4 weeks after TT vaccine
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Measured: 4 weeks after TT vaccine
Mean Levels of Anti-Tetanus Antibody
Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).
Measured: Immediately prior to and at 4 and 8 weeks after TT vaccine
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Anti-KLH antibody levels were assessed by ELISA.
Measured: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Mean Levels of Anti-KLH Antibody: Ig M
Anti-KLH antibody levels were assessed by ELISA.
Measured: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.
Measured: 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Measured: 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Measured: 4 weeks after 23-PPV
Mean Levels of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Measured: Immediately prior to and 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Measured: 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV
Mean Level of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Measured: Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV
Percentage of Participants With Seroprotection
Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination.
Measured: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
2-fold increase from prevaccination HI titer.
Measured: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
4-fold increase from prevaccination HI titer.
Measured: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With Seroconversion
Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer <10 and an HI titer >40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer <10 and HI titer >/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer >/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.
Measured: 4 weeks after influenza immunization
Strain-Specific Geometric Mean Titer Levels
Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.
Measured: Baseline and Week 4
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.
Measured: Immediately prior to and 4 weeks after influenza vaccine
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Categorical Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Normalized Brain Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Volume of T2 Lesions: White Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Cortical Grey Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: T1 Unenhancing Lesion Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
MRI Parameters: Total Number of Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Measured: Baseline
Cellular Immune Response Assessed by Flow Cytometry
Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul.
Repleted is defined as CD19 >= LLN or baseline, whichever is lower.
Measured: Days 1, 15, 85, 112, 140 and 169
Total Immunoglobulin
Measured: Days 1, 85, and 169
Percentage of Participants With Anti-Drug Antibody Formation
Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.
Measured: Up to 24 Weeks (ISP)
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.
Measured: During ISP (24 weeks for Group A and 12 weeks for Group B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start27 Oct 2015
- Primary completion14 Feb 2017
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545868
- Sponsor's protocol ID
- BN29739
- Other IDs
- 2015-001357-32, 2015
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2015
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.
PubMed 32727835
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02545868
- Acronym / sponsor ID
- BN29739
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: OCR + Vaccines | Experimental | Biological: 23-PPV, Biological: 13-PCV Booster, Biological: Influenza Vaccine, Biological: KLH, Drug: OCR, Biological: TT VaccineParticipants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period. |
| Group B: Vaccines (Optional OCR in Extension) | Other | Biological: 23-PPV, Biological: Influenza Vaccine, Biological: KLH, Drug: OCR, Biological: TT VaccineParticipants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of RMS in accordance with the revised McDonald criteria
- Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
- Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
- For sexually active female participants of reproductive potential, use of reliable means of contraception
Key exclusion criteria (3 listed)
- Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
- Known presence of other neurologic disorders
- Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
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 |
|---|---|---|
| 23-PPVThe 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B). | Biological | Group A: OCR + Vaccines, Group B: Vaccines (Optional OCR in Extension) |
| 13-PCV BoosterThe 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A). | Biological | Group A: OCR + Vaccines |
| Influenza VaccineThe influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B). | Biological | Group A: OCR + Vaccines, Group B: Vaccines (Optional OCR in Extension) |
| KLHKLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B). | Biological | Group A: OCR + Vaccines, Group B: Vaccines (Optional OCR in Extension) |
| OCRAlso: RO4964913, PRO70769, rhuMAb 2H7OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms. | Drug | Group A: OCR + Vaccines, Group B: Vaccines (Optional OCR in Extension) |
| TT VaccineThe TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B). | Biological | Group A: OCR + Vaccines, Group B: Vaccines (Optional OCR in Extension) |
Primary outcome
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
Time frame: 8 weeks after TT vaccine
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
31 secondary outcomes
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
Time frame: 4 weeks after TT vaccine
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
Time frame: 4 weeks after TT vaccine
Mean Levels of Anti-Tetanus Antibody
Time frame: Immediately prior to and at 4 and 8 weeks after TT vaccine
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Time frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Mean Levels of Anti-KLH Antibody: Ig M
Time frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Time frame: 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
Time frame: 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
Time frame: 4 weeks after 23-PPV
Mean Levels of Anti-Pneumococcal Antibody
Time frame: Immediately prior to and 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Time frame: 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV
Mean Level of Anti-Pneumococcal Antibody
Time frame: Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV
Percentage of Participants With Seroprotection
Time frame: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Time frame: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Time frame: 4 weeks after seasonal influenza vaccine administration
Percentage of Participants With Seroconversion
Time frame: 4 weeks after influenza immunization
Strain-Specific Geometric Mean Titer Levels
Time frame: Baseline and Week 4
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Time frame: Immediately prior to and 4 weeks after influenza vaccine
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
Time frame: Baseline
MRI Parameters: Number of T2 Lesions
Time frame: Baseline
MRI Parameters: Categorical Number of T2 Lesions
Time frame: Baseline
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
Time frame: Baseline
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Time frame: Baseline
MRI Parameters: Normalized Brain Volume
Time frame: Baseline
MRI Parameters: Volume of T2 Lesions: White Matter Volume
Time frame: Baseline
MRI Parameters: Cortical Grey Matter Volume
Time frame: Baseline
MRI Parameters: T1 Unenhancing Lesion Volume
Time frame: Baseline
MRI Parameters: Total Number of Lesions
Time frame: Baseline
Cellular Immune Response Assessed by Flow Cytometry
Time frame: Days 1, 15, 85, 112, 140 and 169
Total Immunoglobulin
Time frame: Days 1, 85, and 169
Percentage of Participants With Anti-Drug Antibody Formation
Time frame: Up to 24 Weeks (ISP)
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
Time frame: During ISP (24 weeks for Group A and 12 weeks for Group B)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32727835Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.
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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.
Clinical Trials study director
Hoffmann-La Roche
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 23-PPV, 13-PCV Booster and Influenza Vaccine in people with Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 22 sites in 2 countries.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine (time frame: 8 weeks after TT vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545868, which also lists 1 linked publication.
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 26 Mar 2024.