Respiratory Syncytial Virus (RSV)Phase 1NCT04909021
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
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; single-dose) in people with Respiratory Syncytial Virus (RSV), run by Meissa Vaccines, Inc. at 12 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 a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the… Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- 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; single-dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 Jun 2021to Oct 2023
- 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 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-36 months
- Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
- Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
- 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), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
- Prior lab-confirmed RSV infection
- Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation)
- 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 6 months prior to study inoculation, or planned use 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 subject's safety and/or may interfere with study procedures or interpretation of results
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
The Emory Children's Center
Atlanta, Georgia, 30322
Lisa Macoy, 404-727-8440, lisa.simmons.macoy@emory.edu
Evan J Anderson, MD
- Recruiting
Meridian Clinical Research
Binghamton, New York, 41348
Kathe Olmstead, 607-771-1064 ext. 41348, KOlmstead@mcrmed.com
Frank Eder, MD
- Not yet recruiting
PanAmerican Clinical Research
Brownsville, Texas, 78520
Luis E Magana, 956-443-0016, lmagana@panamclinicalresearch.com
Patricia Garza, 956-443-0016, pgarza@panamclinicalresearch.com
- Not yet recruiting
Aventiv Research
Columbus, Ohio, 43213
Cheyanne Wilson, 614-501-6164 ext. 2022, cwilson@aventivresearch.com
Logan Aldrich, 614-501-6164 ext. 3009, sgaines@aventivresearch.co
- Not yet recruiting
Meridian Clinical Research
Hastings, Nebraska, 68901
Miranda D Stahr, 402-407-2800, mstahr@mcrmed.com
Kristine Johnson, 402-407-2800, krjohnson@mcrmed.com
- Not yet recruiting
Clinical Research Prime
Idaho Falls, Idaho, 83404
Mireya Martinez, 208-497-0600 ext. 124, mireya@crprime.com
Karley Morgan, 208-497-0600, karley@crprime.com
- Not yet recruiting
Paradigm Clinical Research
La Mesa, California, 91942
Jamie Howlett, 858-274-4226, jhowlett@paradigm-research.com
Andrea VanDucen, 858-274-4226, avanducen@paradigm-research.com
- Recruiting
MedPharmics
Metairie, Louisiana, 70006
Katelyn Jackson, 504-304-7197, katelynvinet@medpharmics.com
Robert J Jeanfreau, MD
- Recruiting
Meridian Clinical Research
Omaha, Nebraska, 68134
Amy Nichols, 402-933-6500, ANichols@mcrmed.com
Brandon Essink, MD
- Recruiting
MedPharmics
Phoenix, Arizona, 85015
Jason Wallace, 602-368-1928, JasonWallace@medpharmics.co
Charles S Plimpton, MD
- Recruiting
Benchmark Research
San Antonio, Texas, 78240
Jaudohn Hicks, 210-697-3600 ext. 6, jaudohnhicks@benchmarkresearch.net
April Valdvieso, 210-697-3600 ext. 6, aprilvaldvieso@benchmarkresearch.net
- Not yet recruiting
Coastal Pediatric Research
Summerville, South Carolina, 29486
Mathew Thomas, 843-518-5646, mthomas@cpakids.com
Emily McCoy, 843-737-9471, emccoy@cpakids.com
About this study
Official title: Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1c Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine (MV-012-968) in Seronegative Children 6-36 Months
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose), Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose), Placebo (single-dose)
- Keywords
- live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, Pediatric, seronegative, children
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
Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)Biological
Single dose administered intranasally on Day 1
Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)Biological
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Placebo (single-dose)Other
Single dose administered intranasally on Day 1
Placebo (two-dose)Other
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
| 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 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 3: RSV Vaccine Dosage 3 (Single-dose) | 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; single-dose) |
| Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose) | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later Receives: Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) |
| Placebo (Single-dose) | Placebo comparator | Participants in this arm will receive a single intranasal dose of placebo Receives: Other: Placebo (single-dose) |
| Placebo (Two-dose) | Placebo comparator | Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later Receives: Other: Placebo (two-dose) |
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 1 year
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 1 year
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
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
Secondary outcomes (5)
Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant
Measured: Baseline through Day 28, an average of six (6) weeks
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
Change in nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant
Measured: Baseline through Day 28, an average of six (6) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency
Frequency of any post-vaccination shedding of vaccine virus (as detected by plaque assay) after a single intranasal dose of MV-012-968 will be measured per dosage group and overall.
Measured: Intranasal inoculation through Day 22, an average of three (3) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
Measured: Intranasal inoculation through Day 22, an average of three (3) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, duration of shedding (in days) will be measured per dosage group and overall.
Measured: Intranasal inoculation through Day 22, an average of three (3) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start3 Jun 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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 Virus (RSV)Studies 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
- 1st 5 subjects will be in Group 1 and randomized to investigational vaccine (IP) Dosage 1 or placebo. Safety Monitoring Committee (SMC) will review Group 1 data to Day 15 to allow dose escalation. Next 10 subjects will be in Group 2 and randomized to IP Dosage 2 or placebo. SMC will review Group 2 data to Day 15 to allow dose escalation. Next 12 enrolled subjects will be in Group 3 and randomized to IP Dosage 3 or placebo. SMC will review Group 3 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 4 and randomized to IP Dosage 4 or placebo. SMC will review Group 4 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 3a and randomized to IP Dosage 3 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose. Final 12 subjects will be in Group 4a and randomized to IP Dosage 4 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meissa Vaccines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Lieberman, MD, Study director, Meissa Vaccines, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909021
- Sponsor's protocol ID
- MV-006
- Status last verified
- Aug 2022
- First submitted
- 26 May 2021
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1c Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine (MV-012-968) in Seronegative Children 6-36 Months
- ClinicalTrials.gov ID
- NCT04909021
- Acronym / sponsor ID
- MV-006
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, Pediatric, seronegative, children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Meissa Vaccines, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 1 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 evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- 1st 5 subjects will be in Group 1 and randomized to investigational vaccine (IP) Dosage 1 or placebo. Safety Monitoring Committee (SMC) will review Group 1 data to Day 15 to allow dose escalation. Next 10 subjects will be in Group 2 and randomized to IP Dosage 2 or placebo. SMC will review Group 2 data to Day 15 to allow dose escalation. Next 12 enrolled subjects will be in Group 3 and randomized to IP Dosage 3 or placebo. SMC will review Group 3 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 4 and randomized to IP Dosage 4 or placebo. SMC will review Group 4 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 3a and randomized to IP Dosage 3 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose. Final 12 subjects will be in Group 4a and randomized to IP Dosage 4 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose.
| 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 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 3: RSV Vaccine Dosage 3 (Single-dose) | Experimental | Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 |
| Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose) | Experimental | Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later |
| Placebo (Single-dose) | Placebo comparator | Other: Placebo (single-dose)Participants in this arm will receive a single intranasal dose of placebo |
| Placebo (Two-dose) | Placebo comparator | Other: Placebo (two-dose)Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-36 months
- Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
- Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
- 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), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
- Prior lab-confirmed RSV infection
- Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation)
- 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 6 months prior to study inoculation, or planned use 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 |
| Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)Single dose administered intranasally on Day 1 | Biological | Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose) |
| Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit | Biological | Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose) |
| Placebo (single-dose)Single dose administered intranasally on Day 1 | Other | Placebo (Single-dose) |
| Placebo (two-dose)Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit | Other | Placebo (Two-dose) |
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 1 year
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 1 year
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.
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
Time frame: Baseline through Day 28, an average of six (6) weeks
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
5 secondary outcomes
Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
Time frame: Baseline through Day 28, an average of six (6) weeks
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
Time frame: Baseline through Day 28, an average of six (6) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency
Time frame: Intranasal inoculation through Day 22, an average of three (3) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude
Time frame: Intranasal inoculation through Day 22, an average of three (3) weeks
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
Time frame: Intranasal inoculation through Day 22, an average of three (3) weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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.
Jay Lieberman, MD study director
Meissa Vaccines, Inc.
12 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; single-dose) in people with Respiratory Syncytial Virus (RSV), run by Meissa Vaccines, Inc. at 12 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jay Lieberman, MD (3107538943, jay.lieberman@meissavaccines.com), or a site near the patient. 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 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?
On the ClinicalTrials.gov record for NCT04909021, 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 2 Aug 2022.