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RSV Investigational Vaccine in RSV-seropositive Infants Aged 12 to 23 Months

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ClinicalTrials.gov Identifier: NCT02927873
Recruitment Status : Active, not recruiting
First Posted : October 7, 2016
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSV vaccine (GSK3389245A) low dose Biological: RSV vaccine (GSK3389245A) middle dose Biological: RSV vaccine (GSK3389245A) high dose Drug: Placebo LD Drug: Placebo MD Drug: Placebo HD Phase 2

Detailed Description:
The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and single-blinded in Epoch 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : February 19, 2019
Estimated Study Completion Date : November 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSV LD Group
Subjects in this group will receive 2 doses of 0.5 ml of ChAd155 5x10^9 vp, one month apart of the RSV vaccine low dose (LD).
Biological: RSV vaccine (GSK3389245A) low dose
2 doses of 0.5 ml of ChAd155 5x10^9 vp, administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.

Experimental: RSV MD Group
Subjects in this group will receive 2 doses of 0.15 ml of ChAd155 5x10^10 vp, one month apart of the RSV vaccine middle dose (MD).
Biological: RSV vaccine (GSK3389245A) middle dose
2 doses of 0.15 ml of ChAd155 5x10^10 vp administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.

Experimental: RSV HD Group
Subjects in this group will receive 2 doses of 0.5 ml of ChAd155 5x10^10 vp, one month apart of the RSV vaccine high dose (HD).
Biological: RSV vaccine (GSK3389245A) high dose
2 doses of 0.5 ml of ChAd155 5x10^10 vp administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.

Placebo Comparator: Placebo LD group
Subjects in this group will receive 2 doses of 0.15 ml of placebo, one month apart.
Drug: Placebo LD
2 doses of 0.5 ml administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.

Placebo Comparator: Placebo MD group
Subjects in this group will receive 2 doses of 0.5 ml of placebo, one month apart.
Drug: Placebo MD
2 doses of 0.15 ml administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.

Placebo Comparator: Placebo HD group
Subjects in this group will receive 2 doses of 0.5 ml of placebo one month apart.
Drug: Placebo HD
2 doses of 0.5 ml administered intramuscularly at Day 0 and Day 30 in the left anterolateral thigh or deltoid.




Primary Outcome Measures :
  1. Number of subjects with any solicited local adverse events [ Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Relationship analysis was not performed.

  2. Number of subjects with any solicited general adverse events [ Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) ]
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  3. Number of subjects with any unsolicited adverse events (AEs) [ Time Frame: During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days) ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  4. Number of subjects with any serious adverse events (SAEs) [ Time Frame: From Day 0 up to Day 60 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  5. Number of subjects with any AEs of specific interest [ Time Frame: During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days) ]
    AE of specific interest include episodes of spontaneous or excessive bleeding

  6. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 0 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets)

  7. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 1 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets)

  8. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 7 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets)

  9. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 30 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets)

  10. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 31 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets).

  11. Number of subjects with any abnormal laboratory values [ Time Frame: At Day 37 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets).

  12. Number of subjects with any haematological abnormal laboratory values [ Time Frame: At Day 60 ]
    Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets).

  13. Number of subjects with any biochemical abnormal laboratory values [ Time Frame: At Day 0 ]
    Biochemical abnormalities include alanine aminotransferase, aspartate aminotransferase and creatinine laboratory abnormalities

  14. Number of subjects with any biochemical abnormal laboratory values [ Time Frame: At Day 30 ]
    Biochemical abnormalities include alanine aminotransferase, aspartate aminotransferase and creatinine laboratory abnormalities

  15. Number of subjects with any biochemical abnormal laboratory values [ Time Frame: At Day 60 ]
    Biochemical abnormalities include alanine aminotransferase, aspartate aminotransferase and creatinine laboratory abnormalities.


Secondary Outcome Measures :
  1. Number of subjects with any SAEs [ Time Frame: From study start (Day 0) up to study conclusion (Day 730) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  2. Number of subjects with any lower respiratory tract infection associated with RSV infection (RSV-LRTI) [ Time Frame: From Dose 1 administration (Day 0) up to study conclusion (Day 730) ]
    Occurrence of RSV-LRTI AE of specific interest

  3. Number of subjects with any respiratory tract infection associated with RSV infection (RSV-RTI), RSV-LRTI, severe RSV-LRTI (according to standardized case definitions) [ Time Frame: From Dose 1 administration (Day 0) up to study conclusion (Day 730) ]
    Occurrence of RSV-RTI, RSV-LRTI, severe RSV-LRTI

  4. Frequency of CD3+/CD4+ T-cells expressing at least two markers among cluster of differentiation 40-ligand (CD40-L), Interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ) upon stimulation with F, N and M2-1 peptide pools. [ Time Frame: At Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365). ]
    Among immune markers expressed were Interleukin-2 (IL-2), cluster of differentiation 40-ligand (CD40-L), 4-1BB, tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ).

  5. Neutralizing antibody titers against RSV-A [ Time Frame: At Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365) ]
    Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off.

  6. RSV F antibody concentrations. [ Time Frame: At Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365) ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off.

  7. Palivizumab-competing antibody concentrations. [ Time Frame: At Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60) ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off.



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:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects' parent(s)/ Legally acceptable representative (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
  • A male or female between, and including, 12 and 23 months at the time of the first vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Seropositive for RSV as determined by IBL International kit.
  • Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain)
  • Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make IM injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
  • Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines which may be administered ≥ 14 days before a dose or ≥ 7 days after a dose.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Serious chronic illness.
  • Major congenital defects.
  • History of any neurological disorders or seizures.
  • History of or current autoimmune disease.
  • History of recurrent wheezing.
  • History of chronic cough.
  • Previous hospitalization for respiratory illnesses.
  • History of thrombocytopenia.
  • History of anemia.
  • Previous, current or planned administration of Synagis.
  • Neurological complications following any prior vaccination.
  • Born to a mother known or suspected to be HIV-positive.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • Previous vaccination with a recombinant simian or human adenoviral vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Current severe eczema.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be axillary.
    • Clinically significant upper respiratory tract infection
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
  • Any other conditions that the investigator judges may interfere with study procedures or findings.
  • Any conditions that could constitute a risk for the subjects while participating to this study.
  • Weight below the fifth percentile of the local weight-for-age curve.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
  • Planned move to a location that will prohibit participating in the trial until study end.

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): NCT02927873


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02927873     History of Changes
Other Study ID Numbers: 204838
2016-000117-76 ( EudraCT Number )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Safety
Respiratory syncytial virus (RSV)
Immunogenicity
Reactogenicity
Infants
Vaccine
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