Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04227210 |
Recruitment Status :
Completed
First Posted : January 13, 2020
Last Update Posted : September 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Syncytial Virus Infections | Biological: RSV vaccine MV-012-968 (dosage #1) Biological: RSV vaccine MV-012-968 (dosage #2) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | January 14, 2020 |
Actual Primary Completion Date : | August 27, 2020 |
Actual Study Completion Date : | August 27, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: RSV Vaccine: Dosage Group #1
Participants in this group will receive a single dose of the RSV vaccine at dosage #1
|
Biological: RSV vaccine MV-012-968 (dosage #1)
Single dose administered intranasally on Day 1 |
Experimental: RSV Vaccine: Dosage Group #2
Participants in this group will receive a single dose of the RSV vaccine at dosage #2
|
Biological: RSV vaccine MV-012-968 (dosage #2)
Single dose administered intranasally on Day 1 |
- 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.
- Change in serum RSV-specific neutralizing antibody (nAb) titers [ Time Frame: Baseline through study completion, an average of 6 months ]Post-vaccination change in serum RSV-specific nAb titers will be measured per participant.
- Change in serum RSV F-specific binding antibody titers [ Time Frame: Baseline through study completion, an average of 6 months ]Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant.
- Change in mucosal RSV F-specific binding antibody titers [ Time Frame: Baseline through study completion, an average of 6 months ]Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant.
- Potential vaccine virus shedding [ Time Frame: Baseline through 2 months ]The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227210
United States, Kansas | |
Johnson County Clin-Trials | |
Lenexa, Kansas, United States, 66219 |
Study Director: | Oliver Medzihradsky, MD MPH MS | Meissa Vaccines, Inc. |
Responsible Party: | Meissa Vaccines, Inc. |
ClinicalTrials.gov Identifier: | NCT04227210 |
Other Study ID Numbers: |
MV-003 |
First Posted: | January 13, 2020 Key Record Dates |
Last Update Posted: | September 16, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
vaccine live attenuated safety |
immunogenicity viral shedding phase 1 clinical trial |
Respiratory Syncytial Virus Infections Virus Diseases Infections Pneumovirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |