HealthyPhase 1NCT02564237
A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults
A Phase 1 study testing StreptAnova™ (Group A streptococcal (GAS) vaccine), Hepatitis B vaccine and Hepatitis A vaccine in people with Healthy, run by Dalhousie University at 1 site in Canada.
Trial summary
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- StreptAnova™ (Group A streptococcal (GAS) vaccine), Hepatitis B vaccine and Hepatitis A vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy adults ages 18 to 50 years inclusive;
- Good general health as determined by screening evaluation no greater than 42 days before the first immunization;
- For women of childbearing age, use of adequate birth control from enrollment until 180 days after the last injection;
- Written informed consent, after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee.
Who cannot join
- Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization;
- Any chronic illness, whether or not active treatment is required;
- Any immunodeficiency (congenital or acquired);
- Any history of cardiac pathology (acquired or severe/persistent congenital);
- Any history of congenital malformation syndromes associated with congenital heart disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g. Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g. Noonan's);
- Any history of clinical manifestations of auto-immune or systemic diseases (inflammatory disorders, e.g. JRA, SLE, Kawasaki disease; inborn errors of metabolism, e.g. Fabry; connective tissue disorders, e.g. Marfan syndrome; neuromuscular disorders, e.g. Friedreich ataxia; endocrine-metabolic disorders, e.g. hypothyroidism; hematologic disorders, e.g. sickle cell anemia);
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- Any history of acute rheumatic fever (ARF), post-streptococcal glomerulonephritis (PSGN), undiagnosed acute self-limiting polyarthritis (swelling, heat, redness or tenderness or pain and limitation of motion in >2 joints), or chorea (purposeless, involuntary rapid movements of the trunk and/or extremities);
- Any previous echocardiogram suggestive of cardiac pathology;
- Any immediate family history (parents, siblings) of ARF, PSGN, self-limiting polyarthritis, chorea, or a collagen-vascular disease such as Lupus or Sjögren's syndrome;
- Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months;
- Receipt of any investigational drug within six months, or prior participation in a clinical trial of a group A streptococcal vaccine;
- Receipt of blood products or immunoglobulin (IVIg or IMIg) within three (3) months of study entry/baseline serologic evaluation;
- Any physical findings suggestive of acute or chronic illness;
- History of receiving Adriamycin or other chemotherapy;
- Use of any of the following diet pills: fenfluramine, phentermine, or dexfenfluramins (also known as Pondimin, Redux, Adipex, or Fastin);
- History of sensitivity to any component of study vaccines;
- Evidence of tissue cross-reactive antibodies to human heart, joint cartilage, kidney, cerebral cortex or basal ganglia by indirect fluorescent antibody assay at pre-vaccination screening;
- Repeatable clinical laboratory abnormalities (blood or urine), as defined by lab normal ranges. To exclude transient abnormalities, the investigator may repeat a test up to twice, and if the repeat test is normal, subject may be enrolled;
- Echocardiographic finding of valvular dysfunction (stenosis, leaflet thickening or nodules, restricted leaflet mobility, or prolapse), LV dysfunction, atrial or ventricular enlargement, mild or greater mitral regurgitation or aortic insufficiency, moderate or greater tricuspid regurgitation or pulmonic insufficiency, pericardial effusion, or other cardiac pathology as identified by echocardiologist*;
- Receipt of any vaccines within 2 weeks of Dose 1;
- Clinically significant abnormality on screening electrocardiogram*
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Observer-blind, Comparator-controlled, Study of the Safety and Immunogenicity of StreptAnova™ Vaccine in Healthy Adults Age ≥ 18 - 50 Years
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.
Read the detailed description
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™, to be performed in Canada. It will be randomized, observer-blinded, and comparator controlled. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.
A comparator vaccine is included at 2:1 ratio (StreptAnova™ to comparator). Assignment to StreptAnova™ or comparator vaccine will be both randomized and observer-blinded. Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ or 0.5 mL doses of comparator will be administered on days 0, 30 and 180 (N= 30 StreptAnova™, 15 comparator); each subject will receive three doses of the same treatment.
Forty-five subjects will be enrolled. At each vaccine dose, detailed safety data will be collected from the first 15 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the 30 remaining subjects. Detailed safety data will be collected from the remaining 30 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the first 15 randomized subjects at the next dose.
Treatments will be followed by standard clinical parameters for evaluating the safety of a biologic/vaccine product including standardized methods for local and systemic vaccine reactions, repeated vital signs and physical examinations, 12-month follow-up (6 months post-dose 3) for adverse events and concomitant medication changes, and monitoring of clinical laboratory values as clinically indicated.
- Conditions
- Healthy
- Being tested
- StreptAnova™ (Group A streptococcal (GAS) vaccine), Hepatitis B vaccine, Hepatitis A vaccine, Human Papillomavirus vaccine
- Keywords
- Group A streptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StreptAnova™ (Group A streptococcal (GAS) vaccine)Biological
StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine
Hepatitis B vaccineBiological
Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
Hepatitis A vaccineBiological
Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
Human Papillomavirus vaccineBiological
Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: StreptAnova™ | Experimental | Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ (Group A streptococcal (GAS) vaccine) will be will be administered on days 0, 30 and 180. Receives: Biological: StreptAnova™ (Group A streptococcal (GAS) vaccine) |
| Group 2: Comparator | Active comparator | Three (3) 0.5 mL doses of comparator (Hepatitis B vaccine, Hepatitis A vaccine, OR Human Papillomavirus vaccine) will be administered on days 0, 30 and 180. Receives: Biological: Hepatitis B vaccine; Biological: Hepatitis A vaccine; Biological: Human Papillomavirus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: Injection to Day 360, 6 months post dose 3
Secondary outcomes (4)
Occurrence of any hematological and biochemical laboratory abnormality
Measured: Screening, day 0, day 7, day 30, day 44, day 180 and day 194
Occurrence of any unsolicited AE
Measured: During 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to day 360.
Serum antibodies against M protein and Spa antigens in the vaccine measured by ELISA
Measured: Visit 2 (day 0, pre dose 1), Visit 4 (day 30, 30 days post dose 1), Visit 5 (day 44, 14 days post dose 2), Visit 8 (day 210, 30 days post dose 3) and Visit 10 (day 360, 6 months post dose 3)
Functional opsonophagocytosis antibody determination for a subset of M protein serotypes
Measured: Visit 2 (day 0, pre dose 1), Visit 8 (day 210, 30 days post dose 3) and Visit 9 (day 280, 100 days post dose 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly A. McNeil, Dalhousie University
- Investigators
- Shelly McNeil, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564237
- Sponsor's protocol ID
- PE1201
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finn MB, Penfound TA, Salehi S, Ogega CO, Dold C, Plante O, Dale JB. Immunogenicity of a 30-valent M protein mRNA group A Streptococcus vaccine. Vaccine. 2024 Sep 17;42(22):126205. doi: 10.1016/j.vaccine.2024.126205. Epub 2024 Aug 13.
PubMed 39141987Pastural E, McNeil SA, MacKinnon-Cameron D, Ye L, Langley JM, Stewart R, Martin LH, Hurley GJ, Salehi S, Penfound TA, Halperin S, Dale JB. Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study. Vaccine. 2020 Feb 5;38(6):1384-1392. doi: 10.1016/j.vaccine.2019.12.005. Epub 2019 Dec 13.
PubMed 31843270
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer-blind, Comparator-controlled, Study of the Safety and Immunogenicity of StreptAnova™ Vaccine in Healthy Adults Age ≥ 18 - 50 Years
- ClinicalTrials.gov ID
- NCT02564237
- Acronym / sponsor ID
- PE1201
- Conditions
- Healthy
- Keywords
- Group A streptococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Sep 2015 (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 single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.
Detailed description
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™, to be performed in Canada. It will be randomized, observer-blinded, and comparator controlled. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.
A comparator vaccine is included at 2:1 ratio (StreptAnova™ to comparator). Assignment to StreptAnova™ or comparator vaccine will be both randomized and observer-blinded. Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ or 0.5 mL doses of comparator will be administered on days 0, 30 and 180 (N= 30 StreptAnova™, 15 comparator); each subject will receive three doses of the same treatment.
Forty-five subjects will be enrolled. At each vaccine dose, detailed safety data will be collected from the first 15 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the 30 remaining subjects. Detailed safety data will be collected from the remaining 30 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the first 15 randomized subjects at the next dose.
Treatments will be followed by standard clinical parameters for evaluating the safety of a biologic/vaccine product including standardized methods for local and systemic vaccine reactions, repeated vital signs and physical examinations, 12-month follow-up (6 months post-dose 3) for adverse events and concomitant medication changes, and monitoring of clinical laboratory values as clinically indicated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: StreptAnova™ | Experimental | Biological: StreptAnova™ (Group A streptococcal (GAS) vaccine)Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ (Group A streptococcal (GAS) vaccine) will be will be administered on days 0, 30 and 180. |
| Group 2: Comparator | Active comparator | Biological: Hepatitis B vaccine, Biological: Hepatitis A vaccine, Biological: Human Papillomavirus vaccineThree (3) 0.5 mL doses of comparator (Hepatitis B vaccine, Hepatitis A vaccine, OR Human Papillomavirus vaccine) will be administered on days 0, 30 and 180. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female healthy adults ages 18 to 50 years inclusive;
- Good general health as determined by screening evaluation no greater than 42 days before the first immunization;
- For women of childbearing age, use of adequate birth control from enrollment until 180 days after the last injection;
- Written informed consent, after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee.
Key exclusion criteria (22 listed)
- Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization;
- Any chronic illness, whether or not active treatment is required;
- Any immunodeficiency (congenital or acquired);
- Any history of cardiac pathology (acquired or severe/persistent congenital);
- Any history of congenital malformation syndromes associated with congenital heart disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g. Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g. Noonan's);
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 |
|---|---|---|
| StreptAnova™ (Group A streptococcal (GAS) vaccine)StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine | Biological | Group 1: StreptAnova™ |
| Hepatitis B vaccineParticipants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization. | Biological | Group 2: Comparator |
| Hepatitis A vaccineParticipants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization. | Biological | Group 2: Comparator |
| Human Papillomavirus vaccineParticipants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization. | Biological | Group 2: Comparator |
Primary outcome
Occurrence of adverse events
Time frame: Injection to Day 360, 6 months post dose 3
4 secondary outcomes
Occurrence of any hematological and biochemical laboratory abnormality
Time frame: Screening, day 0, day 7, day 30, day 44, day 180 and day 194
Occurrence of any unsolicited AE
Time frame: During 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to day 360.
Serum antibodies against M protein and Spa antigens in the vaccine measured by ELISA
Time frame: Visit 2 (day 0, pre dose 1), Visit 4 (day 30, 30 days post dose 1), Visit 5 (day 44, 14 days post dose 2), Visit 8 (day 210, 30 days post dose 3) and Visit 10 (day 360, 6 months post dose 3)
Functional opsonophagocytosis antibody determination for a subset of M protein serotypes
Time frame: Visit 2 (day 0, pre dose 1), Visit 8 (day 210, 30 days post dose 3) and Visit 9 (day 280, 100 days post dose 3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Derived from this study: PubMed 39141987Finn MB, Penfound TA, Salehi S, Ogega CO, Dold C, Plante O, Dale JB. Immunogenicity of a 30-valent M protein mRNA group A Streptococcus vaccine. Vaccine. 2024 Sep 17;42(22):126205. doi: 10.1016/j.vaccine.2024.126205. Epub 2024 Aug 13.
- Derived from this study: PubMed 31843270Pastural E, McNeil SA, MacKinnon-Cameron D, Ye L, Langley JM, Stewart R, Martin LH, Hurley GJ, Salehi S, Penfound TA, Halperin S, Dale JB. Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study. Vaccine. 2020 Feb 5;38(6):1384-1392. doi: 10.1016/j.vaccine.2019.12.005. Epub 2019 Dec 13.
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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.
Shelly McNeil, MD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing StreptAnova™ (Group A streptococcal (GAS) vaccine), Hepatitis B vaccine and Hepatitis A vaccine in people with Healthy, run by Dalhousie University at 1 site in Canada.
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 22 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: status not confirmed, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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?
Results are not available in the source record.
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 adverse events (time frame: Injection to Day 360, 6 months post dose 3). 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 NCT02564237, which also lists 2 linked publications.
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 19 Jan 2017; AzTrials last refreshed its copy on 2 Nov 2026.