Respiratory Syncytial Virus InfectionsPhase 1NCT04444284
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
A Phase 1 study testing Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2) and Investigational RSV vaccine MV-012-968 (Dosage 3) in people with Respiratory Syncytial Virus Infections, run by Meissa Vaccines, Inc. at 3 sites in United States.
Trial summary
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Read more about this study
- Who is it for?
- Ages 15 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2) and Investigational RSV vaccine MV-012-968 (Dosage 3)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jun 2020to 7 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 15 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 15-59 months
- Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
- Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
- Written informed consent provided by parent(s)/guardian(s)
Who cannot join
- Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
- Known or suspected immunodeficiency
- Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
- Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
- Receipt of an investigational RSV vaccine at any time
- Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Meridian Clinical Research
Norfolk, Nebraska, 68701
Meridian Clinical Research
Omaha, Nebraska, 68134
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Placebo, Investigational RSV vaccine MV-012-968 (Dosage 3)
- Keywords
- Live attenuated vaccine, Safety, Immunogenicity, Phase 1 clinical trial, Pediatric, Seropositive
- 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.
Investigational RSV vaccine MV-012-968 (Dosage 1)Biological
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 2)Biological
Single dose administered intranasally on Day 1
PlaceboOther
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 3)Biological
Single dose administered intranasally on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Dosage Group 1: RSV Vaccine Dosage 1 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1. Receives: Biological: Investigational RSV vaccine MV-012-968 (Dosage 1) |
| Dosage Group 1: Placebo | Placebo comparator | Participants in this arm will receive a single intranasal dose of placebo. Receives: Other: Placebo |
| Dosage Group 2: RSV Vaccine Dosage 2 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2. Receives: Biological: Investigational RSV vaccine MV-012-968 (Dosage 2) |
| Dosage Group 2: Placebo | Placebo comparator | Participants in this arm will receive a single intranasal dose of placebo. Receives: Other: Placebo |
| Dosage Group 3: RSV Vaccine Dosage 3 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3. Receives: Biological: Investigational RSV vaccine MV-012-968 (Dosage 3) |
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 may occur after investigational 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: Full study duration, 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: Full study duration, an average of 6 months
Secondary outcomes (6)
Change in serum RSV-specific neutralizing antibody titers
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
Measured: Baseline through Day 28, an average of six (6) weeks
Change in serum binding (RSV F-specific) antibody titers
Change in serum binding (RSV F-specific) antibody titers will be measured per participant.
Measured: Baseline through Day 28, an average of six (6) weeks
Change in nasal mucosal binding (RSV F-specific) antibody titers
Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.
Measured: Baseline through Day 28, an average of six (6) weeks
Potential vaccine virus shedding: frequency
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.
Measured: Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.
Measured: Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: duration
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.
Measured: Baseline through Day 28, an average of four (4) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start9 Jun 2020
- Primary completion7 May 2021
- Study completion7 May 2021
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
- Sequential
- Model description
- The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 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
- NCT04444284
- Sponsor's protocol ID
- MV-005
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children
- ClinicalTrials.gov ID
- NCT04444284
- Acronym / sponsor ID
- MV-005
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Live attenuated vaccine, Safety, Immunogenicity, Phase 1 clinical trial, Pediatric, Seropositive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Meissa Vaccines, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 23 Jun 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 that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
| Arm | Type | Receives |
|---|---|---|
| Dosage Group 1: RSV Vaccine Dosage 1 | Experimental | Biological: Investigational RSV vaccine MV-012-968 (Dosage 1)Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1. |
| Dosage Group 1: Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a single intranasal dose of placebo. |
| Dosage Group 2: RSV Vaccine Dosage 2 | Experimental | Biological: Investigational RSV vaccine MV-012-968 (Dosage 2)Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2. |
| Dosage Group 2: Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a single intranasal dose of placebo. |
| Dosage Group 3: RSV Vaccine Dosage 3 | Experimental | Biological: Investigational RSV vaccine MV-012-968 (Dosage 3)Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3. |
Who may qualify
- Ages
- 15 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 15-59 months
- Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
- Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
- Written informed consent provided by parent(s)/guardian(s)
Key exclusion criteria (7 listed)
- Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
- Known or suspected immunodeficiency
- Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
- Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
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 |
|---|---|---|
| Investigational RSV vaccine MV-012-968 (Dosage 1)Single dose administered intranasally on Day 1 | Biological | Dosage Group 1: RSV Vaccine Dosage 1 |
| Investigational RSV vaccine MV-012-968 (Dosage 2)Single dose administered intranasally on Day 1 | Biological | Dosage Group 2: RSV Vaccine Dosage 2 |
| PlaceboSingle dose administered intranasally on Day 1 | Other | Dosage Group 1: Placebo, Dosage Group 2: Placebo |
| Investigational RSV vaccine MV-012-968 (Dosage 3)Single dose administered intranasally on Day 1 | Biological | Dosage Group 3: RSV Vaccine Dosage 3 |
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 may occur after investigational 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: Full study duration, 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: Full study duration, 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.
6 secondary outcomes
Change in serum RSV-specific neutralizing antibody titers
Time frame: Baseline through Day 28, an average of six (6) weeks
Change in serum binding (RSV F-specific) antibody titers
Time frame: Baseline through Day 28, an average of six (6) weeks
Change in nasal mucosal binding (RSV F-specific) antibody titers
Time frame: Baseline through Day 28, an average of six (6) weeks
Potential vaccine virus shedding: frequency
Time frame: Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
Time frame: Baseline through Day 28, an average of four (4) weeks
Potential vaccine virus shedding: duration
Time frame: Baseline through Day 28, an average of four (4) weeks
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 29 Jun 2021.
- Results publication: 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2) and Investigational RSV vaccine MV-012-968 (Dosage 3) in people with Respiratory Syncytial Virus Infections, run by Meissa Vaccines, Inc. at 3 sites 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 7 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 29 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 3 sites 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. 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?
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 NCT04444284, 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 29 Jun 2021.