Respiratory Syncytial Virus InfectionsPhase 1NCT04227210
Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
A Phase 1 study testing RSV vaccine MV-012-968 (dosage #1) and RSV vaccine MV-012-968 (dosage #2) in people with Respiratory Syncytial Virus Infections, run by Meissa Vaccines, Inc. at 1 site in United States.
Trial summary
This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV vaccine MV-012-968 (dosage #1) and RSV vaccine MV-012-968 (dosage #2)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 27 Aug 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult 18-40 years of age
- In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
- RSV 'sero-low' from a pre-vaccination serum sample
- Signed informed consent form
Who cannot join
- Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
- Prior receipt of an investigational RSV vaccine
- Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
- Any other reason the Investigator considers exclusionary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults
This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSV vaccine MV-012-968 (dosage #1), RSV vaccine MV-012-968 (dosage #2)
- Keywords
- vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV vaccine MV-012-968 (dosage #1)Biological
Single dose administered intranasally on Day 1
RSV vaccine MV-012-968 (dosage #2)Biological
Single dose administered intranasally on Day 1
| Study group | Role | What they receive |
|---|---|---|
| RSV Vaccine: Dosage Group #1 | Experimental | Participants in this group will receive a single dose of the RSV vaccine at dosage #1 Receives: Biological: RSV vaccine MV-012-968 (dosage #1) |
| RSV Vaccine: Dosage Group #2 | Experimental | Participants in this group will receive a single dose of the RSV vaccine at dosage #2 Receives: Biological: RSV vaccine MV-012-968 (dosage #2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events (AEs)
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration.
Measured: Immediate post-vaccination period
Unsolicited AEs
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Measured: Immediate post-vaccination period
Serious adverse events (SAEs)
Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Measured: Vaccination through study completion, an average of 6 months
Medically attended adverse events (MAEs)
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
Measured: Vaccination through study completion, an average of 6 months
Secondary outcomes (4)
Change in serum RSV-specific neutralizing antibody (nAb) titers
Post-vaccination change in serum RSV-specific nAb titers will be measured per participant.
Measured: Baseline through study completion, an average of 6 months
Change in serum RSV F-specific binding antibody titers
Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant.
Measured: Baseline through study completion, an average of 6 months
Change in mucosal RSV F-specific binding antibody titers
Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant.
Measured: Baseline through study completion, an average of 6 months
Potential vaccine virus shedding
The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant.
Measured: Baseline through 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start14 Jan 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
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 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
- Model description
- Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meissa Vaccines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Medzihradsky, MD MPH MS, Study director, Meissa Vaccines, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227210
- Sponsor's protocol ID
- MV-003
- Status last verified
- Sep 2020
- First submitted
- 6 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.
PubMed 28000669
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT04227210
- Acronym / sponsor ID
- MV-003
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meissa Vaccines, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 13 Jan 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 study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
| Arm | Type | Receives |
|---|---|---|
| RSV Vaccine: Dosage Group #1 | Experimental | Biological: RSV vaccine MV-012-968 (dosage #1)Participants in this group will receive a single dose of the RSV vaccine at dosage #1 |
| RSV Vaccine: Dosage Group #2 | Experimental | Biological: RSV vaccine MV-012-968 (dosage #2)Participants in this group will receive a single dose of the RSV vaccine at dosage #2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult 18-40 years of age
- In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
- RSV 'sero-low' from a pre-vaccination serum sample
- Signed informed consent form
Key exclusion criteria (4 listed)
- Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
- Prior receipt of an investigational RSV vaccine
- Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
- Any other reason the Investigator considers exclusionary
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 |
|---|---|---|
| RSV vaccine MV-012-968 (dosage #1)Single dose administered intranasally on Day 1 | Biological | RSV Vaccine: Dosage Group #1 |
| RSV vaccine MV-012-968 (dosage #2)Single dose administered intranasally on Day 1 | Biological | RSV Vaccine: Dosage Group #2 |
Primary outcome
Solicited adverse events (AEs)
Time frame: Immediate post-vaccination period
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration.
Unsolicited AEs
Time frame: Immediate post-vaccination period
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Serious adverse events (SAEs)
Time frame: Vaccination through study completion, an average of 6 months
Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Medically attended adverse events (MAEs)
Time frame: Vaccination through study completion, an average of 6 months
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
4 secondary outcomes
Change in serum RSV-specific neutralizing antibody (nAb) titers
Time frame: Baseline through study completion, an average of 6 months
Change in serum RSV F-specific binding antibody titers
Time frame: Baseline through study completion, an average of 6 months
Change in mucosal RSV F-specific binding antibody titers
Time frame: Baseline through study completion, an average of 6 months
Potential vaccine virus shedding
Time frame: Baseline through 2 months
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 16 Sep 2020.
- Background: PubMed 28000669Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.
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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.
Oliver Medzihradsky, MD MPH MS study director
Meissa Vaccines, Inc.
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 RSV vaccine MV-012-968 (dosage #1) and RSV vaccine MV-012-968 (dosage #2) in people with Respiratory Syncytial Virus Infections, run by Meissa Vaccines, Inc. at 1 site in United States.
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 4 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 16 Sep 2020. 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 States. 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?
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?
Solicited adverse events (AEs) (time frame: Immediate post-vaccination period). 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?
On the ClinicalTrials.gov record for NCT04227210, 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 16 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.