Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 75 for:    "Rabies" | "Immunologic Factors"

A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02545517
Recruitment Status : Active, not recruiting
First Posted : September 10, 2015
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
GlaxoSmithKline (GSK) Biologicals' Rabipur vaccine is indicated for active immunization against rabies in individuals of all ages. This includes pre-exposure prophylaxis (PrEP), in both primary series and booster dose, and post exposure prophylaxis.The aim of this extension study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen No new subjects were enrolled in this study.

Condition or disease Intervention/treatment Phase
Virus Diseases Biological: Rabipur Procedure: Blood sampling Phase 3

Detailed Description:

The protocol was amended to clarify:

  • Timeframe between each yearly scheduled visit,
  • Number of additional booster doses a subject may receive depending on the RVNA level reached,
  • Premature withdrawal from the study
  • Exclusion criteria on scheduled visits
  • That only SAEs experienced by subjects who received the booster must be reported
  • Rewording of the protocol.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is an open label study. The laboratory that performed the serology analysis was blinded to treatment arm.
Primary Purpose: Prevention
Official Title: A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.
Actual Study Start Date : October 5, 2015
Estimated Primary Completion Date : December 3, 2022
Estimated Study Completion Date : December 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: Conv-R/JE Group
Subjects who completed the Rabies PrEP regimen on days 1,8 and 29 and JE primary series regimen on days 1 and 29 in the parent study V49_23 were enrolled in the Conv-R/JE Group and received a single booster dose of the PCEC rabies vaccine in this extension study.
Biological: Rabipur
Subjects in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm

Procedure: Blood sampling
Blood samples were drawn from all subjects at day 1 and then at subsequent year intervals from extension study day 1 onwards.

Experimental: Acc-R/JE Group
Subjects who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study V49_23 were enrolled in the Acc-R/JE Group and received a single booster dose of the PCEC rabies vaccine in this extension study.
Biological: Rabipur
Subjects in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm

Procedure: Blood sampling
Blood samples were drawn from all subjects at day 1 and then at subsequent year intervals from extension study day 1 onwards.

Experimental: Conv-R Group
Subjects who completed the Rabies PrEP regimen on days 1,8 and 29 in the parent study V49_23 were enrolled into the Conv-R Group and received a single booster dose of the PCEC rabies vaccine in this extension study.
Biological: Rabipur
Subjects in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm

Procedure: Blood sampling
Blood samples were drawn from all subjects at day 1 and then at subsequent year intervals from extension study day 1 onwards.




Primary Outcome Measures :
  1. Number of subjects reporting serious adverse events (SAEs) after a booster dose of PCEC (purified chick embryo cell culture) rabies vaccine [ Time Frame: From the time of booster dose administration(Day 1 in extension study)until completion of safety follow-up period(day of next Scheduled Clinic Visit after booster dose/on date of Early Termination Visit, whichever is earlier,assessed up to year 10) ]

    An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following:

    • Death
    • Is life-threatening
    • Requires or prolonged hospitalization.
    • Persistent or significant disability/incapacity
    • Congenital anomaly/or birth defect.
    • An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

    Safety is assessed as the number of subjects reporting SAEs after a booster dose of PCEC rabies vaccine following a primary series of accelerated or conventional rabies PrEP (pre-exposure) IM (intramuscular) regimen in the parent study V49_23.


  2. Time to first RVNA (Rabies Virus Neutralizing Antibodies) concentrations <0.5 IU/mL. [ Time Frame: Throughout the study duration (From 1 year after primary dose schedule in parent study V49_23 to year 10). ]
    The time until RVNA concentrations drop below 0.5 IU/mL is calculated to compare the long-term persistence of antibody responses in subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study V49_23

  3. RVNA concentrations in terms of Geometric Mean Concentrations (GMCs) 7 days after the booster dose. [ Time Frame: At 7 days after booster dose ]
    Antibody concentrations at 7 days after booster dose are measured in terms of GMCs.

  4. RVNA Geometric Mean Ratios (GMRs) at 7 days after the booster dose vs. antibody concentration before the booster dose. [ Time Frame: At 7 days after booster dose versus before booster dose administration (baseline- 6 months before booster dose). ]
    For subjects receiving a booster dose, analysis of boostability is conducted 7 days after administration of the booster dose by providing GMRs and associated CIs, considering the antibody value at the time of booster dose administration as baseline.

  5. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis at 7 days after booster dose. [ Time Frame: At 7 days after booster dose ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at 7 days after booster dose

  6. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 3 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 3 after primary series of vaccination.

  7. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 4 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 4 after primary series of vaccination.

  8. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 5 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 5 after primary series of vaccination.

  9. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 6 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 6 after primary series of vaccination.

  10. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 7 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 7 after primary series of vaccination.

  11. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 8 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 8 after primary series of vaccination.

  12. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 9 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 9 after primary series of vaccination.

  13. Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL as measured by RFFIT (Rapid Fluorescent Focus Inhibition Test) analysis. [ Time Frame: At year 10 after primary series of vaccine administration. ]
    The percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL are measured at year 10 after primary series of vaccination.


Secondary Outcome Measures :
  1. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 3 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 3 after primary series of vaccination

  2. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 4 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 4 after primary series of vaccination

  3. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 5 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 5 after primary series of vaccination

  4. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 6 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 6 after primary series of vaccination

  5. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 7 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 7 after primary series of vaccination

  6. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 8 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 8 after primary series of vaccination

  7. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 9 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 9 after primary series of vaccination

  8. RVNA Geometric Mean Concentrations (GMCs) [ Time Frame: At year 10 after primary series of vaccine administration. ]
    The RVNA GMCs with the 95% CI are calculated at Year 10 after primary series of vaccination

  9. Reverse Cumulative Distribution Plots (RCDPs) for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 3 ]
    The RCDPs are provided by treatment group, at year 3

  10. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 4 ]
    The RCDPs are provided by treatment group, at year 4

  11. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 5 ]
    The RCDPs are provided by treatment group, at year 5

  12. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 6 ]
    The RCDPs are provided by treatment group, at year 6

  13. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 7 ]
    The RCDPs are provided by treatment group, at year 7

  14. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 8 ]
    The RCDPs are provided by treatment group, at year 8

  15. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 9 ]
    The RCDPs are provided by treatment group, at year 9

  16. RCDPs for subjects with RVNA concentrations ≥0.5 IU/mL. [ Time Frame: At year 10 ]
    The RCDPs are provided by treatment group, at year 10



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

  1. All individuals who were randomized to Conventional Rabies and JE vaccination or to Accelerated Rabies and JE vaccination or to Conventional Rabies groups during the parent study, who received the full PrEP regimen and completed the trial following V49_23 study protocol.
  2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  3. Individuals who can comply with study procedures
  4. Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method which they intend to use for at least 6 months after the booster vaccination. This criterion is applicable only for those subjects who receive a booster dose.

Prior to receipt of booster vaccination during Ad hoc Clinic Visit, subjects must be evaluated to confirm that they are eligible. If subjects do not meet any of the original inclusion criteria listed above, they should not receive booster dose of rabies vaccine.

Exclusion Criteria:

Prior to extension study entry, each subject must not have:

  1. Completed the parent study V49_23 without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
  2. History of exposure to suspected or confirmed rabid animal.
  3. Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of V49_23 study.
  4. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
  5. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
  7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
  8. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
  9. Study personnel as well as their immediate family or household member.
  10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Prior to Scheduled Visit, each subject must not have:

  1. History of exposure to suspected or confirmed rabid animal.
  2. Receipt of rabies immunoglobulins, non-study rabies vaccine following completion of V49_23 study.
  3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
  4. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  5. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
  6. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
  7. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
  8. Study personnel as well as their immediate family or household member.
  9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Prior to booster vaccination, each subject eligible for booster vaccination (i.e., subjects with RVNA concentrations <0.5 IU/mL at the first visit of this extension study [Day 1, Year 3] or at the following year visits [Year 4 to Year 9]) should be in good health status and must not have none of the following:

  1. Progressive, unstable or uncontrolled clinical conditions.
  2. Abnormal function of the immune system resulting from:

    1. Clinical conditions.
    2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study.
    3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study.
  3. Receipt of non-study rabies vaccine.
  4. Receipt of any other vaccines within 28 days prior to the booster dose or planning to receive any vaccine within 28 days from the booster dose.
  5. Receipt of any investigational or non-registered medicinal product within 14 days before booster dose till next Scheduled Clinic Visit after booster dose administration.
  6. Receipt of anti-malarial medications within 14 days before booster dose till next Scheduled Clinic Visit after booster dose administration.

Prior to receipt of booster study vaccination, subjects must be evaluated to confirm that they are in good health and they are eligible for subsequent vaccination. If subjects meet any of the original exclusion criteria listed above, they should not receive additional vaccinations.


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): NCT02545517


Locations
Layout table for location information
Austria
GSK Investigational Site
Wien, Austria, 1090
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80802
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20359
Switzerland
GSK Investigational Site
Zuerich, Switzerland, 8001
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02545517     History of Changes
Other Study ID Numbers: 205214
2015-000382-31 ( EudraCT Number )
V49_23E1 ( Other Identifier: Novartis )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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.

Keywords provided by GlaxoSmithKline:
Rabies disease
Pre-exposure (PrEP) or post exposure prophylaxis (PEP)
Long-term Immunogenicity

Additional relevant MeSH terms:
Layout table for MeSH terms
Rabies
Virus Diseases
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs