Respiratory Syncytial Virus InfectionsPhase 1NCT04295070
Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers
A Phase 1 study testing CodaVax-RSV and Normal saline in people with Respiratory Syncytial Virus Infections, run by Codagenix, Inc at 1 site in Australia.
Trial summary
This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- CodaVax-RSV and Normal saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jul 2020to 26 May 2021
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 50 to 75 years of age, inclusive (at the time of informed consent) for the main dosing group or healthy male and female volunteers aged 18 to 49 years of age, inclusive (at the time of informed consent) for the sentinel group;
- Body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 35 kg/m2;
- Participants must be willing to comply with the following conditions to prevent the spread of genetically modified organisms (GMOs) according the Office of the Gene Technology Regulator (OGTR) Licence (DIR 144):
- Hygiene measures intended to prevent interpersonal transmission of study drug must be implemented, including but not limited to frequent handwashing with soap or hand disinfectant, respiratory hygiene and cough etiquette within 7 days after each vaccination
- Blood, tissue or organs must not be donated within 7 days after each vaccination
- Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days after each vaccination
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- Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days after each vaccination
- All tissues and materials used to collect respiratory secretions for 7 days after each vaccination are to be sealed in a primary container and placed within a secondary container so that it is not accessible to children or animals for 7 days until it is returned to the study site for disposal
- Adequate venous access for repeated phlebotomies;
- Screening laboratory results within the normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome;
- Negative drug and alcohol screen at Screening (unless explained by prescribed medication);
- For participants in the main dosing groups, eligible RSV neutralizing antibody titer as defined in the previous seroepidemiology study;
- Women of childbearing potential (WOCBP) must be non-pregnant and non lactating, and must use an acceptable, highly effective double barrier contraception from Screening until 28 days after the final vaccination. Double contraception is defined as a condom AND one other form of the following:
- Established hormonal contraception (oral contraceptive pills [OCPs], long acting implantable hormones, injectable hormones);
- A vaginal ring or an intrauterine device (IUD);
- Documented evidence of surgical sterilisation at least 6 months prior to screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner) Women not of childbearing potential must be postmenopausal for greater or equal to 12 months. Postmenopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels greater or equal to 40 IU/mL at Screening for amenorrhoeic female participants.
- Females who are abstinent from heterosexual intercourse will also be eligible. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control.
- Female participants who are in same sex relationships are not required to use contraception.
- WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study;
- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective double barrier contraceptive method from Screening until until 28 days after the final vaccination. Acceptable methods of double barrier contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- Males must not donate sperm for at least 90 days after the final vaccination;
- Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
- Participants must be willing and able to provide written informed consent prior to the commencement of any study procedures.
Who cannot join
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) prior to 28 days after the final vaccination;
- Household contacts or caregivers of infants < 12 months of age or immunocompromised individuals (for the period up through 28 days post final vaccination). Immunocompromised individuals defined as but not limited to:
- Persons who are human immunodeficiency virus (HIV)-infected
- Persons who have received chemotherapy within 6 months
- Persons receiving immunosuppressive agents
- Person living with solid organ or bone marrow transplant;
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- Positive result for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) at Screening;
- Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following history related to asthma or lung disease:
- Daily symptoms for more than 1 week in the past 5 years;
- Use of short acting beta 2 agonists in the past 5 years (e.g., albuterol);
- Use of inhaled steroids, theophylline or pulse systemic steroids in the past 5 years; or
- Any history of intubation or hospitalization related to asthma or other chronic lung disease.
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently within the normal range);
- History of coronary artery disease, arrhythmia, or congestive heart failure;
- Clinically significant ECG abnormality as determined by the Investigator at Screening;
- Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg) at Screening or predose on Day 1;
- History of anaphylaxis or angioedema;
- History of severe reaction to immunization;
- Known allergy to any of the ingredients in the vaccine formulation;
- History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might alter nasal mucosa and affect vaccine response;
- Previous nasal surgery or nasal cauterization;
- Epistaxis (nosebleed), symptoms of upper respiratory infection or subjective fever or malaise within 3 days prior to dosing on Day 1 (temporary exclusion criterion);
- Any symptoms or signs on Day 1 that could inhibit the proper administration of the investigational product (IP) or interpretation of solicited AEs diary (e.g., temperature >38°C, nasal congestion or rhinorrhea) (temporary exclusion criteria);
- Known or suspected malignancy, except for non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur;
- Immunodeficiency including the use of corticosteroids (including IN steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days prior to dosing on Day 1, or for those participants that plan to use any of these during the study follow-up period. Topical steroid creams used on the skin are allowed;
- History of bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions);
- History of autoimmune or demyelinating illness;
- History of psychosis, hospitalization for psychiatric illness, or suicide attempt in the past 10 years;
- History of seizures (other than childhood febrile seizures), dementia or progressive neurological disease;
- Receipt of IN medications (including over the counter [OTC] medications but excluding saline) within 30 days prior to Day 1;
- Receipt of any other IP within 30 days or 5 half lives (whichever is longer) prior to Day 1;
- Receipt of any vaccine, tuberculosis (TB) skin test or allergy antigen inoculations within 30 days prior to Day 1 or planned up to Day 57;
- Receipt of IN vaccine within 90 days prior to Day 1;
- Receipt of any licensed or investigational RSV vaccine;
- Receipt of blood transfusion or blood products within 90 days prior to Day 1 or planned up through Day 57;
- Planned elective hospitalization or surgical procedure through Day 57;
- Other chronic medical conditions not mentioned must be stable without necessitating medication changes within 30 days prior to Day 1;
- Past regular use or current use of IN illicit drugs;
- Smokers of any type (e.g., cigarettes, electronic cigarettes, marijuana). Prior smokers must have quit smoking at least 30 days prior to Day 1;
- Employee of Codagenix, vendors, or research sites associated with the study;
- Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgment of the Investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a participant's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First in Human, Randomized, Double-blind, Placebo Controlled Study of the Safety, Tolerability, and Immunogenicity of the CodaVax-RSV Vaccine in Healthy Adult Volunteers
This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- CodaVax-RSV, Normal saline
- Keywords
- RSV, live-attenuated vaccine, codon deoptimized, respiratory infection
- Medical subject headings
- Respiratory Syncytial Virus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CodaVax-RSVBiological
Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper
Normal salineBiological
Saline (0.9%) administered via dropper
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline (0.9%) delivered intranasally via dropper Receives: Biological: Normal saline |
| Low dose cohort | Experimental | CodaVax-RSV delivered intranasally via dropper Receives: Biological: CodaVax-RSV |
| High dose cohort | Experimental | CodaVax-RSV delivered intranasally via dropper Receives: Biological: CodaVax-RSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity counts
Counts of participants with local and systemic events along with symptom severity and duration
Measured: Days 1 through 7
Reactogenicity percentages
Percentages of participants with local and systemic events along with symptom severity and duration
Measured: Days 1 through 7
Adverse events counts
Counts of participants with AEs not included as reactogenicity events
Measured: Days 1 through 57
Adverse events percentages
Percentages of participants with AEs not included as reactogenicity events
Measured: Days 1 through 57
Serious adverse events
Number of medically-attended AEs (MAEs), new onset chronic illnesses (NCIs), and serious AEs (SAEs) will be captured
Measured: Days 1 through 209
Secondary outcomes (6)
RSV-specific IgG
Titer of RSV-specific immunoglobulin G (IgG) antibodies measured by enzyme-linked immunosorbent assay (ELISA) in serum
Measured: Days 1, 15, 29, 43, 57, 113, and 209
Seroconversion rate IgG
Percent of participants with at least 4-fold increase in RSV-specific IgG as measured by ELISA over baseline
Measured: Days 1, 15, 29, 43, 57, 113, and 209
Neutralizing antibodies
Titer of neutralizing antibodies in serum measured via RSV micro neutralization assay
Measured: Days 1, 15, 29, 43, 57, 113, and 209
Percent of patients seroconverting via neutralizing antibodies
Percent of participants with at least 4- fold increase in neutralizing antibodies in serum over baseline
Measured: Days 1, 15, 29, 43, 57, 113, and 209
RSV-specific IgA
Geometric mean titer (GMT) of antibodies measured by ELISA in nasopharyngeal (NP) swab specimens
Measured: Days 1, 15, 29, 43 and 57
Percent of patients seroconverting via IgA
Percent of participants with at least 4 fold increases in RSV-specific IgA over baseline
Measured: Days 1, 15, 29, 43 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Jul 2020
- Primary completion6 Mar 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codagenix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295070
- Sponsor's protocol ID
- CODA-RSV-001
- Status last verified
- Jun 2021
- First submitted
- 28 Feb 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Randomized, Double-blind, Placebo Controlled Study of the Safety, Tolerability, and Immunogenicity of the CodaVax-RSV Vaccine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04295070
- Acronym / sponsor ID
- CODA-RSV-001
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV, live-attenuated vaccine, codon deoptimized, respiratory infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- 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 Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Normal salineSaline (0.9%) delivered intranasally via dropper |
| Low dose cohort | Experimental | Biological: CodaVax-RSVCodaVax-RSV delivered intranasally via dropper |
| High dose cohort | Experimental | Biological: CodaVax-RSVCodaVax-RSV delivered intranasally via dropper |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Healthy men and women aged 50 to 75 years of age, inclusive (at the time of informed consent) for the main dosing group or healthy male and female volunteers aged 18 to 49 years of age, inclusive (at the time of informed consent) for the sentinel group;
- Body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 35 kg/m2;
- Participants must be willing to comply with the following conditions to prevent the spread of genetically modified organisms (GMOs) according the Office of the Gene Technology Regulator (OGTR) Licence (DIR 144):
- Adequate venous access for repeated phlebotomies;
- Screening laboratory results within the normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome;
Key exclusion criteria (41 listed)
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) prior to 28 days after the final vaccination;
- Household contacts or caregivers of infants < 12 months of age or immunocompromised individuals (for the period up through 28 days post final vaccination). Immunocompromised individuals defined as but not limited to:
- Positive result for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) at Screening;
- Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following history related to asthma or lung disease:
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently within the normal range);
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 |
|---|---|---|
| CodaVax-RSVCodon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper | Biological | High dose cohort, Low dose cohort |
| Normal salineSaline (0.9%) administered via dropper | Biological | Placebo |
Primary outcome
Reactogenicity counts
Time frame: Days 1 through 7
Counts of participants with local and systemic events along with symptom severity and duration
Reactogenicity percentages
Time frame: Days 1 through 7
Percentages of participants with local and systemic events along with symptom severity and duration
Adverse events counts
Time frame: Days 1 through 57
Counts of participants with AEs not included as reactogenicity events
Adverse events percentages
Time frame: Days 1 through 57
Percentages of participants with AEs not included as reactogenicity events
Serious adverse events
Time frame: Days 1 through 209
Number of medically-attended AEs (MAEs), new onset chronic illnesses (NCIs), and serious AEs (SAEs) will be captured
6 secondary outcomes
RSV-specific IgG
Time frame: Days 1, 15, 29, 43, 57, 113, and 209
Seroconversion rate IgG
Time frame: Days 1, 15, 29, 43, 57, 113, and 209
Neutralizing antibodies
Time frame: Days 1, 15, 29, 43, 57, 113, and 209
Percent of patients seroconverting via neutralizing antibodies
Time frame: Days 1, 15, 29, 43, 57, 113, and 209
RSV-specific IgA
Time frame: Days 1, 15, 29, 43 and 57
Percent of patients seroconverting via IgA
Time frame: Days 1, 15, 29, 43 and 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 CodaVax-RSV and Normal saline in people with Respiratory Syncytial Virus Infections, run by Codagenix, Inc at 1 site in Australia.
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 23 inclusion and 41 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 10 Jun 2021. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reactogenicity counts (time frame: Days 1 through 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.