Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)

Respiratory Syncytial Virus Infection Clinical Trial

Official title:

Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687279
• Other study ID #: VAD00014
• Secondary ID: U1111-1278-3910
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 6, 2023
• Est. completion date: January 23, 2025

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.

Description:

The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 23, 2025
• Est. primary completion date: January 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• Aged 6 months to < 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday)
• Participants who are healthy as determined by medical evaluation including medical history.
• Born at full term of pregnancy (= 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
• Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to < 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to < 24 months of age who will participate in this study

Exclusion Criteria:

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Probable or confirmed ongoing case of COVID-19 at the time of enrollment
• Member of a household that contains an immunocompromised individual, including, but

not limited to:

• a person who is HIV infected
• a person who has received chemotherapy within the 12 months prior to study enrollment
• a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
• a person living with a solid organ or bone marrow transplant
• Member of a household that includes, or will include, an infant who is less than 6 months of age at the time of enrollment
• Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/legally acceptable representative is unable or unwilling to suspend attendance at the daycare facility for 28 days following study intervention administration
• Any need of supplemental oxygen therapy in a home or hospital setting at the time of enrollment.
• Participant's mother previous receipt or planned administration of an investigational RSV vaccine or any monoclonal antibody (such as Infliximab) during pregnancy and/or breastfeeding.
• Receipt or planned receipt of any of the following vaccines prior to or after the

first study intervention administration:

• any influenza vaccine within 7 days prior to and after, or any COVID-19 or inactivated vaccine or live-attenuated rotavirus vaccine within 14 days prior to and after, or
• any live vaccine, other than rotavirus vaccine, within 28 days prior to and after
• Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV Immunoglobulin (IG) or RSV monoclonal antibody) at the time of enrollment.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
• Receipt at the time of enrollment or previous receipt of salicylate (aspirin) or salicylate-containing products
• Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Deprived of freedom in an emergency setting, or hospitalized involuntarily
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSVt Vaccine
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal

Other:
• Control Group
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal

Locations

Country	Name	City	State
Puerto Rico	Investigational Site Number : 6300004	Bayamón
Puerto Rico	Investigational Site Number : 6300002	Carolina
Puerto Rico	Investigational Site Number : 6300003	Guayama
Puerto Rico	Investigational Site Number : 6300001	San Juan
United States	Meridian Clinical Research Norfolk Site Number : 8400003	Norfolk	Nebraska
United States	Velocity Clinical Research, Omaha Site Number : 8400001	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of vaccine virus	Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	Day 1 through Day 22
Primary	Change in the Geometric Mean Titers (GMTs) of vaccine virus shedding	Titer of vaccine virus shedding in nasal swabs, quantified by qRT-PCR Assay in all pediatric participants	Day 1 through Day 71
Primary	Number of differences detected in genetic sequence of NS2 segment	Number of differences detected in genetic sequence of NS2 segment of the vaccine virus compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo and ad hoc close contact participants	Approximately Day 1 through Day 85
Secondary	Geometric Mean Titers (GMTs) of RSV A serum neutralizing antibody (nAb) titers	RSV A serum Nab titers	Day 1, Day 57 and Day 85
Secondary	GMTs of RSV serum anti-F Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) antibody titers up to 28 days after the second administration (D01, D57, and D85)	RSV serum anti-F IgG ELISA antibody titers	Day 1, Day 57 and Day 85
Secondary	Presence of immediate unsolicited systemic Adverse Events (AEs)	Number of participants experiencing immediate unsolicited systemic AEs	Within 30 minutes after each vaccination administration
Secondary	Presence of solicited injection site or systemic reactions	Number of participants reporting: injection site reactions: pain, erythema and swelling; systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills	Within 21 days after each vaccination administration
Secondary	Presence of unsolicited AEs	Number of participants experiencing unsolicited AEs	Within 28 days after each vaccination administration
Secondary	Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Within 28 days after each vaccination administration
Secondary	Presence of medically attended adverse events (MAAEs)	Number of participants experiencing MAAEs	Within 28 days after each vaccination administration
Secondary	Presence of serious adverse events (SAEs)	Number of participants experiencing SAEs	From Day 1 until the end of the study (approximately 8 months)
Secondary	Presence of vaccine virus at Day 64 through Day 71	Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)	Day 64 through Day 71