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Study of a Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (VAD00001)

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ClinicalTrials.gov Identifier: NCT04491877
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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 RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in Respiratory Syncytial Virus (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-A anti-F immunoglobulin G antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
  • To characterize serum RSV-A antibody responses (neutralizing and anti-F immunoglobulin G) to the study product in each vaccine group after the RSV season 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 1 Phase 2

Detailed Description:
Study duration per participant is maximum 12 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 : September 17, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of participants reporting immediate adverse events [ Time Frame: Within 30 minutes after vaccination ]
    Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.

  2. Number of participants reporting solicited reactions [ Time Frame: Within 28 days after vaccination ]
    Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.

  3. Number of participants reporting unsolicited adverse events [ Time Frame: Within 28 days after vaccination ]
    Unsolicited adverse events are spontaneously reported adverse events.

  4. Number of participants reporting adverse events of special interest [ Time Frame: Within 28 days after vaccination ]
    Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.

  5. Number of participants reporting medically attended adverse events [ Time Frame: 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.

  6. Number of participants reporting serious adverse events [ Time Frame: Day 0 to maximum Month 12 ]
    Serious adverse events are collected throughout the study, from Day 0 up to 1 month after the end of the RSV season.

  7. Vaccine-induced RSV-A serum neutralizing antibody levels after first vaccine administration [ Time Frame: Day 56 ]
    Vaccine induced RSV-A serum neutralizing antibody levels assessed in RSV seronegative participants in Cohorts 1, 2, 3, and 4.

  8. Vaccine-induced RSV-A serum neutralizing antibody levels after second vaccine administration [ Time Frame: Day 84 ]
    Vaccine induced RSV-A serum neutralizing antibody levels are assessed in RSV seronegative participants in Cohorts 2 and 4.


Secondary Outcome Measures :
  1. Titer of vaccine virus shedding (plaque assay) [ Time Frame: 7 and 10 days after vaccination ]
    Titers are assessed by plaque assay.

  2. Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR]) [ Time Frame: 7 and 10 days after vaccination ]
    Titers are assessed by PCR.

  3. Number of participants infected with the vaccine virus [ Time Frame: 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.

  4. Vaccine-induced RSV-A serum neutralizing antibody levels [ Time Frame: Day 56 and Day 84 ]
    RSV-A 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.

  5. Vaccine-induced RSV-A F binding antibody levels [ Time Frame: Day 56 and Day 84 ]
    RSV-A 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.

  6. RSV-A antibody titers after the RSV surveillance season [ Time Frame: Within 1 month after the end of the RSV season ]
    Serum RSV-A antibody titers (neutralizing and anti-F) 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).



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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.
  • 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 or RSV monoclonal antibody).
  • Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment.
  • 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.

    o 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. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • 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).
  • 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.
  • Any previous anaphylactic reaction.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • Born at less than 34 weeks gestation.
  • Born at less than 37 weeks gestation and less than 1 year of age at the time

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

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): NCT04491877


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, California
Investigational Site Number 8400012 Recruiting
Huntington Park, California, United States, 90255
Investigational Site Number 8400016 Recruiting
San Diego, California, United States, 92123-1881
United States, Idaho
Investigational Site Number 8400001 Recruiting
Blackfoot, Idaho, United States, 83221
United States, Indiana
Investigational Site Number 8400024 Recruiting
South Bend, Indiana, United States, 46617
United States, Kansas
Investigational Site Number 8400014 Recruiting
El Dorado, Kansas, United States, 67042
Investigational Site Number 8400002 Recruiting
Newton, Kansas, United States, 67114
United States, Kentucky
Investigational Site Number 8400013 Recruiting
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
Investigational Site Number 8400006 Recruiting
Covington, Louisiana, United States, 70433
Investigational Site Number 8400017 Recruiting
New Orleans, Louisiana, United States, 70125
United States, Montana
Investigational Site Number 8400011 Recruiting
Missoula, Montana, United States, 59804
United States, Nebraska
Investigational Site Number 8400005 Recruiting
Norfolk, Nebraska, United States, 68701
United States, Utah
Investigational Site Number 8400023 Recruiting
West Jordan, Utah, United States, 84088-8865
United States, Virginia
Investigational Site Number 8400007 Recruiting
Charlottesville, Virginia, United States, 22911
Investigational Site Number 8400004 Recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Investigational Site Number 8400008 Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04491877    
Other Study ID Numbers: VAD00001
U1111-1238-1869 ( Other Identifier: UTN )
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs