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

NCT02927873 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2048382016-000117-76
• Study Type: interventional
• Target: 107
• Locations: 8 countries
• Sites: 24

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Safety; Respiratory syncytial virus (RSV); Immunogenicity; Reactogenicity; Infants; Vaccine

Outcome Measures

Primary Outcomes (13)

• Number of Subjects With Any Solicited Local Adverse Events (AEs)

  Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

  During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

• Number of Subjects With Any Solicited General AEs

  Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.

  During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

• Number of Subjects With Any Unsolicited AEs

  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. Unsolicited AEs are 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.

  During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

• Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61

  Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

  From Day 1 up to Day 61

• Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)

  Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.

  During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].

  At Day 2

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].

  At Day 8

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31\].

  At Day 31

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32\].

  At Day 32

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].

  At Day 38

• Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61

  Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61\].

  At Day 61

• Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31

  Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].

  At Day 31

• Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61

  Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\].

  At Day 61

Secondary Outcomes (10)

• Number of Subjects With Any SAEs From Day 1 up to Day 366

  From Day 1 up to Day 366

• Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366

  From Dose 1 administration (Day 1) up to Day 366

• Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366

  From Dose 1 administration (Day 1) up to Day 366

• Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731

  From Day 1 up to study conclusion at Day 731

• Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731

  From Dose 1 administration (Day 1) up to study conclusion at Day 731

Study Arms (6)

RSV LD Group

EXPERIMENTAL

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.

Biological: RSV (GSK3389245A) low dose formulation vaccine

RSV MD Group

EXPERIMENTAL

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.

Biological: RSV (GSK3389245A) middle dose formulation vaccine

RSV HD Group

EXPERIMENTAL

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.

Biological: RSV (GSK3389245A) high dose formulation vaccine

Placebo LD group

PLACEBO COMPARATOR

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.

Drug: Placebo

Placebo MD group

PLACEBO COMPARATOR

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.

Drug: Placebo

Placebo HD group

PLACEBO COMPARATOR

RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.

Drug: Placebo

Interventions

RSV (GSK3389245A) low dose formulation vaccine BIOLOGICAL

2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

RSV LD Group

RSV (GSK3389245A) middle dose formulation vaccine BIOLOGICAL

2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

RSV MD Group

RSV (GSK3389245A) high dose formulation vaccine BIOLOGICAL

2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

RSV HD Group

Placebo DRUG

2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Placebo HD group; Placebo LD group; Placebo MD group

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Anaheim, California, 92804, United States

Location

GSK Investigational Site

Aurora, Colorado, 80045, United States

Location

GSK Investigational Site

Topeka, Kansas, 66604, United States

Location

GSK Investigational Site

Frederick, Maryland, 21702, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57105, United States

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Milan, Lombardy, 20122, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06132, Italy

Location

GSK Investigational Site

México, 04530, Mexico

Location

GSK Investigational Site

David, Chiriquí Province, 0401, Panama

Location

GSK Investigational Site

Panama City, 0801, Panama

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Majadahonda (Madrid), 28222, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Valencia, 46020, Spain

Location

GSK Investigational Site

Hsinchu, 300, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Diez-Domingo J, Saez-Llorens X, Rodriguez-Weber MA, Epalza C, Chatterjee A, Chiu CH, Lin CY, Berry AA, Martinon-Torres F, Baquero-Artigao F, Langley JM, Ramos Amador JT, Domachowske JB, Huang LM, Chiu NC, Esposito S, Moris P, Lien-Anh Nguyen T, Nikic V, Woo W, Zhou Y, Dieussaert I, Leach A, Gonzalez Lopez A, Vanhoutte N. Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. J Infect Dis. 2023 May 29;227(11):1293-1302. doi: 10.1093/infdis/jiac481.

  PMID: 36484484 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: January 11, 2017
• Primary Completion: February 19, 2019
• Study Completion: November 26, 2020
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

IT (2); US (6); ME (1); ES (7); TW (4); PL (1); CA (1); PA (2)