VAD00001: Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04491877

Collaborator

(none)

300

Enrollment

Locations

Arms

31.3

Anticipated Duration (Months)

10.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of the study are:

To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline neutralizing antibody serostatus.
To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seronegative participants.

The secondary objectives of the study are:

To quantify the amount of vaccine virus shed by each participant by baseline neutralizing antibody serostatus.
To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus after vaccination by baseline neutralizing antibody serostatus.
To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seropositive participants.
To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline neutralizing antibody serostatus.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infection	Biological: RSV vaccine formulation 1 Biological: RSV vaccine formulation 2 Biological: Placebo	Phase 2

Detailed Description

Study duration per participant is maximum 12 months

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The study is performed in an observer-blind fashion. Investigators and study staff who conduct the safety assessment and the participants do not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation knows which vaccine is administered.

Primary Purpose:

Prevention

Official Title:

Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

Actual Study Start Date :

Sep 17, 2020

Anticipated Primary Completion Date :

Apr 27, 2023

Anticipated Study Completion Date :

Apr 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 (RSV vaccine formulation 1) 1 administration of RSV vaccine formulation 1 on Day 0	Biological: RSV vaccine formulation 1 Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 1 (Placebo) 1 administration of placebo on Day 0	Biological: Placebo Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 2 (RSV vaccine formulation 1) 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56	Biological: RSV vaccine formulation 1 Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 2 (Placebo) 2 administrations of placebo on Day 0 and Day 56	Biological: Placebo Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 3 (RSV vaccine formulation 2) 1 administration of RSV vaccine formulation 2 on Day 0	Biological: RSV vaccine formulation 2 Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 3 (Placebo) 1 administration of placebo on Day 0	Biological: Placebo Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 4 (RSV vaccine formulation 1) 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56	Biological: RSV vaccine formulation 1 Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Experimental: Cohort 4 (RSV vaccine formulation 2) 2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56	Biological: RSV vaccine formulation 2 Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 4 (Placebo) 2 administrations of placebo on Day 0 and Day 56	Biological: Placebo Pharmaceutical form: Suspension Route of administration: Intranasal

Outcome Measures

Primary Outcome Measures

Number of participants reporting immediate adverse events [Within 30 minutes after vaccination]
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.
Number of participants reporting solicited reactions [Within 28 days after vaccination]
Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Number of participants reporting unsolicited adverse events [Within 28 days after vaccination]
Unsolicited adverse events are spontaneously reported adverse events.
Number of participants reporting adverse events of special interest [Within 28 days after vaccination]
Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.
Number of participants reporting medically attended adverse events [Within 28 days after vaccination]
Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
Number of participants reporting serious adverse events [Day 0 to maximum Month 12]
Serious adverse events are collected throughout the study, from Day 0 until the end of the study.
RSV A serum neutralizing antibody levels after first vaccine administration [Day 56]
RSV A serum neutralizing antibody levels assessed in RSV seronegative participants in Cohorts 1, 2, 3, and 4.
RSV A serum neutralizing antibody levels after second vaccine administration [Day 84]
RSV A serum neutralizing antibody levels are assessed in RSV seronegative participants in Cohorts 2 and 4.

Secondary Outcome Measures

Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR]) [7 days after vaccination]
Titers are assessed by PCR at Day 7 for Cohorts 1, 2, 3 and 4 and Day 63 for Cohorts 2 and 4.
Number of participants infected with the vaccine virus [Day 56 and Day 84]
Infection is defined as detection of vaccine in nasal wash by culture or PCR and / or a ≥ 4-fold rise in serum neutralizing antibodies or in serum antibodies to RSV F. Infectivity is assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4
RSV A serum neutralizing antibody levels [Day 56 and Day 84]
RSV serum neutralizing antibody levels assessed in seropositive participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
RSV serum anti-F binding antibody levels [Day 56 and Day 84]
RSV serum anti-F binding antibody levels assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
RSV A serum neutralizing and serum anti-RSV F IgG antibody titers after the RSV surveillance season or at least 5 months after the last vaccine administration [Within 1 month after the end of the RSV season or at least 5 months after the last vaccine administration.]
RSV A serum neutralizing and serum anti-RSV F IgG antibody titers are assessed after the end of the RSV season (on average end of March in the Northern Hemisphere and end of September in the Southern Hemisphere) or at least 5 months after the last vaccine administration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion criteria :

Aged 6 through 18 months at Day 0.
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations).
Participant and parent / guardian / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

Born at less than 34 weeks gestation
Born at less than 37 weeks gestation and less than 1 year of age at the time
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).
Probable or confirmed case of Coronavirus Disease 2019 (COVID-19).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Any chronic illness

• Chronic illness may include, but is not limited to, cardiac disorders, lung disease (including any history of reactive airway disease, receipt of bronchodilator therapy, or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases

Any history of medically diagnosed wheezing
Any acute febrile, respiratory or gastrointestinal illness in the past 24 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. ebrile event has subsided
Any previous anaphylactic reaction
Current suspected or documented developmental disorder, delay, or other developmental problem
Receipt of any of the following vaccines prior to enrollment:
any influenza vaccine within 7 days prior, or
any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
another investigational vaccine or investigational drug within 28 days prior
Previous receipt of a licensed or investigational RSV vaccine or previous receipt or planned administration of any anti-RSV product (such as ribavirin or RSV immune immune globulins [IG] or RSV monoclonal antibody)
Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
Receipt of any of the following medications within 3 days prior to study enrollment (Day 0):
systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
intranasal medications, or
other prescription medication except as permitted concomitant medications (prescription or non-prescription) including nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents
Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days prior to enrollment (Day 0)
Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary.
Scheduled administration of the following after planned inoculation:
any influenza vaccine within 7 days after, or
inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
any live vaccine other than rotavirus in the 28 days after, or
another investigational vaccine or investigational drug in the 56 days after.
Any previous receipt of supplemental oxygen therapy in a home or hospital setting, except the temporary receipt of supplemental oxygen for transient tachypnea in newborn
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 enrollment
a person receiving immunosuppressant agents
a person living with a solid organ or bone marrow transplant
Participation at the time of study enrollment (or in the 6 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date (or in the 6 weeks preceding the first trial vaccination) through Day 28
Member of a household that contains another child/other children who is/are, or is/are scheduled to be, enrolled in this study in the same year AND the date of enrollment will not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date)
Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation
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 participant's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number :8400012	Gardena	California	United States	90247
2	Investigational Site Number :8400026	La Mesa	California	United States	91942
3	Investigational Site Number :8400032	Los Angeles	California	United States	90057
4	Investigational Site Number :8400016	San Diego	California	United States	92123-1881
5	Investigational Site Number :8400001	Blackfoot	Idaho	United States	83221
6	Investigational Site Number :8400022	Idaho Falls	Idaho	United States	83404
7	Investigational Site Number :8400036	Idaho Falls	Idaho	United States	83404
8	Investigational Site Number :8400024	South Bend	Indiana	United States	46617
9	Investigational Site Number :8400014	El Dorado	Kansas	United States	67042
10	Investigational Site Number :8400002	Newton	Kansas	United States	67114
11	Investigational Site Number :8400013	Nicholasville	Kentucky	United States	40356
12	Investigational Site Number :8400006	Covington	Louisiana	United States	70433
13	Investigational Site Number :8400017	New Orleans	Louisiana	United States	70125
14	Investigational Site Number :8400053	Minneapolis	Minnesota	United States	55402
15	Investigational Site Number :8400011	Missoula	Montana	United States	59804
16	Investigational Site Number :8400005	Norfolk	Nebraska	United States	68701
17	Investigational Site Number :8400040	Albuquerque	New Mexico	United States	87102
18	Investigational Site Number :8400030	Binghamton	New York	United States	13901
19	Investigational Site Number :8400043	Greenville	North Carolina	United States	27834
20	Investigational Site Number :8400031	Charleston	South Carolina	United States	29414
21	Investigational Site Number :8400027	Greenville	South Carolina	United States	29607
22	Investigational Site Number :8400041	Salt Lake City	Utah	United States	84107
23	Investigational Site Number :8400007	Charlottesville	Virginia	United States	22911
24	Investigational Site Number :8400004	Richmond	Virginia	United States	23294
25	Investigational Site Number :8400008	Spokane	Washington	United States	99202
26	Investigational Site Number :1520001	Santiago	Reg Metropolitana De Santiago	Chile	8380453
27	Investigational Site Number :1520004	Santiago	Reg Metropolitana De Santiago	Chile	8420383
28	Investigational Site Number :3400002	Municipio Del Distrito Central		Honduras	11101
29	Investigational Site Number :3400001	San Pedro Sula		Honduras	21104

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi Pasteur, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT04491877

Other Study ID Numbers:

VAD00001
U1111-1238-1869

First Posted:

Jul 29, 2020

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 5, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Vaccines

Study Results

No Results Posted as of Jul 6, 2022