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Completed

NCT Number: NCT04227210

Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus 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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Meissa Vaccines, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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