Respiratory Syncytial Viral InfectionsPhase 1SynGEMNCT02958540
Phase I Study for SynGEM, an Intranasal Respiratory Syncytial Virus (RSV) Prefusion F Subunit Candidate Vaccine
A Phase 1 study testing SynGEM in people with Respiratory Syncytial Viral Infections, run by Mucosis BV at 1 site in United Kingdom.
Trial summary
The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Viral Infections
- What is being tested?
- SynGEM
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 49 years inclusive.
- Able to give written informed consent to participate.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical judgment.
- Must have acceptable laboratory parameters* within 28 days before Day 1. Acceptable laboratory parameters are defined as follows:
- Hemoglobin, Red Blood Cell (RBC) count and hematocrit: within laboratory normal sex-specific range.
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- White Blood Cell (WBC) count within the normal laboratory range C. Sodium and potassium within laboratory normal range D. Total bilirubin within laboratory normal range E. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): ≤1.1x institutional ULN.
- Serum creatinine: ≤1.1x institutional upper limit of normal (ULN).
- Note: If the acceptable laboratory screening parameters listed above are out of the above defined range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out-of-range value. Out of range results for laboratory tests either listed or not in Section 8.6.3 other than those covered in the list above are acceptable if considered not clinically significant by the Investigator.
- A Body Mass Index (BMI) between 18 and 32, inclusive. BMI = weight (kg)/height2 (m2).
- Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine β-hCG pregnancy test within 24 hours preceding receipt of each dose and agree to practice, if not already practicing, highly effective birth control measures from 28 days before the prime vaccination until at least 90 days after the boost vaccination. For women already practicing highly effective birth control measurements for at least 28 days at screening start, recruitment can occur as soon as all screening procedures are completed. The following birth control measure will be considered highly effective:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner (if the partner is the sole sexual partner and has received medical assessment of the surgical success).
- True abstinence: when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception].
- If not heterosexually active at screening, must agree to practice highly effective birth control measures described above if they become heterosexually active from that moment onwards until at least 90 days after the boost vaccination.
- Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 90 days after the boost vaccination.
- Women of non-childbearing potential, defined as postmenopausal (>45 years of age with amenorrhea for ≥2 years; for female of >45 years of age with amenorrhea for more than 6 months but less than 2 years confirmation of a serum follicle stimulating hormone (FSH) >40 mIU/mL will be required to consider them of non-childbearing potential) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as described in Inclusion Criterion #7.
- A man who has not had a vasectomy with medical assessment of the surgical success and is sexually active with a woman of childbearing potential must agree to consistently use a barrier method of birth control, such as condom with spermicidal foam/gel/film/cream/suppository. Men must also agree not to donate sperm from the first study vaccine administration (Day 1) until 90 days after the boost vaccination.
- Subjects must be willing to provide verifiable identification and their National Insurance/Passport number for the purpose of The Over-volunteering Prevention System (TOPS) registration.
- Subject must have a means to be contacted.
Who cannot join
- History of acute respiratory disease in the 30 days preceding start of screening or documented infection with RSV in the previous 3 months.
- Any chronic disease of the nasal cavity such as chronic hypertrophic or atrophic rhinitis, chronic sinusitis, ozena, Wegener's granulomatosis or granulomatosis with polyangiitis.
- History of asthma or chronic obstructive pulmonary disease.
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of a new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening.
- Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- Pregnant or breastfeeding women, or planning to become pregnant while enrolled in the study or within 90 days after the boost vaccination.
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- Cancer, or treatment for cancer, within 3 years, excluding basal cell carcinoma or squamous cell carcinoma of the skin, which is allowed.
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.
- Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulins, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Topical corticosteroids are allowed.
- Receipt of any intranasal administration of drug or vaccine within the 30 days prior to the first administration of study vaccine or plans to receive any intranasal administration of drug or vaccine until the end of study visit.
- Receipt of live attenuated vaccine within 30 days of first SynGEM® administration or plans to receive within 30 days after the last study vaccine administration, and receipt of any other vaccine within 15 days of first SynGEM® administration or plans to receive within 15 days after the last study vaccine administration.
- Positive history of illicit drug use, of drug or alcohol abuse within the previous 6 months.
- History of anaphylactic type reaction to injected vaccines.
- History of allergic rhinitis or of allergy to food.
- History of allergy to insect bites, latex, pollens, house dust mites that are considered significant by the Investigator.
- Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or with more than 2 IMPs in the past year.
- Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period.
- Loss of ˃ 500 mL blood within 3 months prior to screening.
- Any major neurological disease, including migraine
- Any condition that, in the Investigator's opinion, might interfere with the primary study objectives.
- Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever, or a fever >38ºC does not represent an absolute exclusion criterion, but an exclusion criterion at that moment in time. Prime vaccination can be re-scheduled as deemed necessary by the Investigator.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Centre for Translational and Experimental Medicine Hammersmith Hospital
London
About this study
Official title: Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially.
Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points.
Read the detailed description
A total of 48 healthy adult volunteers aged 18 to 49 years will be recruited. The first 24 subjects will be randomized 3:1 to SynGEM® low dose level (140 μg F-protein/2mg BLPs) or placebo administered at Day 1 and Day 29 (Group 1). After completion of recruitment of Group 1, if no pausing rule is met until 7 days post prime in all Group 1 subjects, 24 additional subjects will be randomized 3:1 to SynGEM® high dose level (350 μg F-protein/2mg BLPs) or placebo administered at Day 1 and Day 29 (Group 2).
Recruitment will be guided by pre-specified pausing rules. Recruitment of Group 1 will be staggered as follows: a sentinel cohort of 2 subjects (1 subject receiving SynGEM® and 1 subject receiving placebo) will be recruited on study Day 1; subjects will be followed up to Visit 2 (3 days post-dosing) and if no pausing rule is met, a second cohort of 2 subjects (1 subject receiving SynGEM® and 1 subject receiving placebo) will be vaccinated; subjects will be followed up to Visit 2 (3 days post-dosing) and if no pausing rule is met, recruitment will be extended to the remaining 20 subjects (16 on SynGEM®/4 on placebo) of Group 1.
Escalation to the high dose level will be implemented only after collection of safety data of all subjects in Group 1 for at least 7 days post-prime if no pausing rule is met. Group 2 will also be comprised of a total of 24 subjects and recruitment will be staggered and subjected to the same pausing rules as in Group 1.
Each subject will return to the site for study visits 3, 7 and 28 days post-prime vaccination; 28 days after prime vaccination the boost vaccination will be administered and subjects will return 3, 7, 28 days after boost vaccination. A primary analysis will be carrying out on data collected up to this timepoints. Subjects will be followed up for safety and immunogenicity thereafter up to 180 days post-prime.
- Conditions
- Respiratory Syncytial Viral Infections
- Being tested
- SynGEM, placebo
- Keywords
- Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynGEMBiological
Prime / boost vaccination in each group
placeboOther
prime /boost vaccination
| Study group | Role | What they receive |
|---|---|---|
| SynGEM low dose | Experimental | Group 1: 18 subjects receiving SynGEM low dose Receives: Biological: SynGEM |
| SynGEM high dose | Experimental | Group 2: 18 subjects receiving SynGEM high dose Receives: Biological: SynGEM |
| placebo | Placebo comparator | 12 subjects receiving placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event
subjects' diary
Measured: 7 days post each dose / 57 days post prime
Secondary outcomes (1)
Immunogenicity responses
At baseline (day 1), Day 8, 29, 36, 57, 120, 180
Measured: up to 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Viral InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mucosis BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Chris Chiu, PhD, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958540
- Sponsor's protocol ID
- MUC-SynGEM-001
- Other IDs
- 2015-003814-25, 2015
- Acronym
- SynGEM
- Status last verified
- Sep 2017
- First submitted
- 4 Nov 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ascough S, Vlachantoni I, Kalyan M, Haijema BJ, Wallin-Weber S, Dijkstra-Tiekstra M, Ahmed MS, van Roosmalen M, Grimaldi R, Zhang Q, Leenhouts K, Openshaw PJ, Chiu C. Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Aug 15;200(4):481-492. doi: 10.1164/rccm.201810-1921OC.
PubMed 30753101
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
- ClinicalTrials.gov ID
- NCT02958540
- Acronym / sponsor ID
- SynGEM / MUC-SynGEM-001
- Conditions
- Respiratory Syncytial Viral Infections
- Keywords
- Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mucosis BVIndustry (pharma, biotech, devices)
- Collaborators
- Imperial College London
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Nov 2016 (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.
The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially.
Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points.
Detailed description
A total of 48 healthy adult volunteers aged 18 to 49 years will be recruited. The first 24 subjects will be randomized 3:1 to SynGEM® low dose level (140 μg F-protein/2mg BLPs) or placebo administered at Day 1 and Day 29 (Group 1). After completion of recruitment of Group 1, if no pausing rule is met until 7 days post prime in all Group 1 subjects, 24 additional subjects will be randomized 3:1 to SynGEM® high dose level (350 μg F-protein/2mg BLPs) or placebo administered at Day 1 and Day 29 (Group 2).
Recruitment will be guided by pre-specified pausing rules. Recruitment of Group 1 will be staggered as follows: a sentinel cohort of 2 subjects (1 subject receiving SynGEM® and 1 subject receiving placebo) will be recruited on study Day 1; subjects will be followed up to Visit 2 (3 days post-dosing) and if no pausing rule is met, a second cohort of 2 subjects (1 subject receiving SynGEM® and 1 subject receiving placebo) will be vaccinated; subjects will be followed up to Visit 2 (3 days post-dosing) and if no pausing rule is met, recruitment will be extended to the remaining 20 subjects (16 on SynGEM®/4 on placebo) of Group 1.
Escalation to the high dose level will be implemented only after collection of safety data of all subjects in Group 1 for at least 7 days post-prime if no pausing rule is met. Group 2 will also be comprised of a total of 24 subjects and recruitment will be staggered and subjected to the same pausing rules as in Group 1.
Each subject will return to the site for study visits 3, 7 and 28 days post-prime vaccination; 28 days after prime vaccination the boost vaccination will be administered and subjects will return 3, 7, 28 days after boost vaccination. A primary analysis will be carrying out on data collected up to this timepoints. Subjects will be followed up for safety and immunogenicity thereafter up to 180 days post-prime.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SynGEM low dose | Experimental | Biological: SynGEMGroup 1: 18 subjects receiving SynGEM low dose |
| SynGEM high dose | Experimental | Biological: SynGEMGroup 2: 18 subjects receiving SynGEM high dose |
| placebo | Placebo comparator | Other: placebo12 subjects receiving placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Male or female aged 18 - 49 years inclusive.
- Able to give written informed consent to participate.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical judgment.
- Must have acceptable laboratory parameters* within 28 days before Day 1. Acceptable laboratory parameters are defined as follows:
Key exclusion criteria (21 listed)
- History of acute respiratory disease in the 30 days preceding start of screening or documented infection with RSV in the previous 3 months.
- Any chronic disease of the nasal cavity such as chronic hypertrophic or atrophic rhinitis, chronic sinusitis, ozena, Wegener's granulomatosis or granulomatosis with polyangiitis.
- History of asthma or chronic obstructive pulmonary disease.
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of a new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening.
- Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
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 |
|---|---|---|
| SynGEMPrime / boost vaccination in each group | Biological | SynGEM high dose, SynGEM low dose |
| placeboprime /boost vaccination | Other | placebo |
Primary outcome
Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event
Time frame: 7 days post each dose / 57 days post prime
subjects' diary
1 secondary outcome
Immunogenicity responses
Time frame: up to 180 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Derived from this study: PubMed 30753101Ascough S, Vlachantoni I, Kalyan M, Haijema BJ, Wallin-Weber S, Dijkstra-Tiekstra M, Ahmed MS, van Roosmalen M, Grimaldi R, Zhang Q, Leenhouts K, Openshaw PJ, Chiu C. Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Aug 15;200(4):481-492. doi: 10.1164/rccm.201810-1921OC.
- Individual participant dataSharing planned: Undecided
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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.
Chris Chiu, PhD, MD principal investigator
Imperial College London
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 SynGEM in people with Respiratory Syncytial Viral Infections, run by Mucosis BV at 1 site in United Kingdom.
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 19 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: status not confirmed, as of the sponsor's last update on 8 Sep 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event (time frame: 7 days post each dose / 57 days post prime). 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 NCT02958540, 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 8 Sep 2017.