Respiratory Syncytial Virus InfectionsPhase 1NCT04919109
Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
A Phase 1 study testing CodaVax-RSV and Normal Saline in people with Respiratory Syncytial Virus Infections, run by Codagenix, Inc at 5 sites in 2 countries.
Trial summary
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- 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
- 41 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Mar 2023to 8 Jul 2026
- 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 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age at the time of informed consent:
- Part A: 2 to 5 years, inclusive
- Part B: 6 months to < 2 years
- RSV Status at Screening:
- Part A: RSV-seropositive
- Part B: RSV-seronegative
- Good general health status
- Product of normal full-term pregnancy (36 to 42 weeks gestation)
Who cannot join
- Household contact with any of the following groups of individuals for the period up to 14 days after each dose:
- Pregnant women
- Infants < 6 months of age
- With hospitalization for asthma or other chronic respiratory disease in the past 5 years
- Immunocompromised individuals, which includes, but is not limited to, those with the following conditions:
- AIDS
Show all 13Show fewer
- Receipt of chemotherapy within the past 6 months
- Current receipt of immunosuppressive agents
- Solid organ or bone marrow transplant
- Enrolled in the same classroom at full-time day care with infants < 6 months of age for 14 days after each dose
- Household contact of another child enrolled into the study
- Inadequate venous access for repeated phlebotomy
- Height and weight ≤ 5th percentile for age and sex (according to CDC growth charts for children in Part A, according to World Health Organization Child Growth Standards for children in Part B)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Velocity
Lincoln, Nebraska, 658510
Velocity
Omaha, Nebraska, 68134
Velocity
Providence, Rhode Island, 02818
Velocity
West Jordan, Utah, 84088
South Africa1 site
University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to < 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart.
A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose.
Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- CodaVax-RSV, Normal Saline
- Keywords
- RSV, Live-attenuated vaccine, respiratory infection, Pediatric, Codon-deoptimized
- 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
live attenuated vaccine against RSV
Normal SalineBiological
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator | Placebo comparator | Administered as nose drops Receives: Biological: Normal Saline |
| Experimental: CodaVax-RSV 10^6 PFU | Experimental | Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops Receives: Biological: CodaVax-RSV |
| Experimental: CodaVax-RSV 10^5 PFU | Experimental | Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops Receives: Biological: CodaVax-RSV |
| Experimental: CodaVax-RSV 10^4 PFU | Experimental | Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops Receives: Biological: CodaVax-RSV |
| Experimental: CodaVax-RSV 10^3 PFU | Experimental | Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops Receives: Biological: CodaVax-RSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting expected adverse reactions
Reactogenicity Event Counts
Measured: Day 7
Number of participants reporting expected adverse reactions
Reactogenicity Event Counts
Measured: Day 36
Number of participant reported adverse events
Adverse event counts
Measured: Days 57
Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)
counts
Measured: Days 210
Secondary outcomes (1)
Neutralizing antibody
Neutralizing antibody level
Measured: Screening, Days 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start28 Mar 2023
- Primary completion26 Jun 2025
- Study completion8 Jul 2026
Why it stopped: Sponsor Decision
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 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
- NCT04919109
- Sponsor's protocol ID
- CDX-RSV-101P
- Status last verified
- Jul 2026
- First submitted
- 26 May 2021
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
- ClinicalTrials.gov ID
- NCT04919109
- Acronym / sponsor ID
- CDX-RSV-101P
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV, Live-attenuated vaccine, respiratory infection, Pediatric, Codon-deoptimized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 9 Jun 2021 (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 study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to < 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart.
A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose.
Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator | Placebo comparator | Biological: Normal SalineAdministered as nose drops |
| Experimental: CodaVax-RSV 10^6 PFU | Experimental | Biological: CodaVax-RSVRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops |
| Experimental: CodaVax-RSV 10^5 PFU | Experimental | Biological: CodaVax-RSVRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops |
| Experimental: CodaVax-RSV 10^4 PFU | Experimental | Biological: CodaVax-RSVRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops |
| Experimental: CodaVax-RSV 10^3 PFU | Experimental | Biological: CodaVax-RSVRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age at the time of informed consent:
- RSV Status at Screening:
- Good general health status
- Product of normal full-term pregnancy (36 to 42 weeks gestation)
Key exclusion criteria (13 listed)
- Household contact with any of the following groups of individuals for the period up to 14 days after each dose:
- Enrolled in the same classroom at full-time day care with infants < 6 months of age for 14 days after each dose
- Household contact of another child enrolled into the study
- Inadequate venous access for repeated phlebotomy
- Height and weight ≤ 5th percentile for age and sex (according to CDC growth charts for children in Part A, according to World Health Organization Child Growth Standards for children in Part B)
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-RSVlive attenuated vaccine against RSV | Biological | Experimental: CodaVax-RSV 10^3 PFU, Experimental: CodaVax-RSV 10^4 PFU, Experimental: CodaVax-RSV 10^5 PFU, Experimental: CodaVax-RSV 10^6 PFU |
| Normal SalinePlacebo comparator | Biological | Placebo comparator |
Primary outcome
Number of participants reporting expected adverse reactions
Time frame: Day 7
Reactogenicity Event Counts
Number of participants reporting expected adverse reactions
Time frame: Day 36
Reactogenicity Event Counts
Number of participant reported adverse events
Time frame: Days 57
Adverse event counts
Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)
Time frame: Days 210
counts
1 secondary outcome
Neutralizing antibody
Time frame: Screening, Days 29 and 57
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- 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.
5 sites in 2 countries: 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 5 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, South Africa. 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 was stopped early (reason given: Sponsor Decision). 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?
Number of participants reporting expected adverse reactions (time frame: Day 7). The study lists 4 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 15 Jul 2026.