Virus DiseasesPhase 1NCT04062669

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

A Phase 1 study testing Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) and Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) in people with Virus Diseases, run by GlaxoSmithKline at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM [CNE] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 *-month schedule to… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Virus Diseases
What is being tested?: Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) and Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 4 sitesUnited States
Study dates: 13 Aug 2019to 1 Jul 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. participation in genetics research, completion of the electronic diary cards, return for follow-up visits).
Written informed consent obtained from the participant prior to performance of any study specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female participant between, and including, 18 and 40 years of age at the time of the first vaccination.
Body Mass Index >18 Kg/m^2 and <35 Kg/m^2.
Participants with following hematological/biochemical parameters:

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White Blood Cells and differential, within the study designated laboratory normal range. Participants with FDA toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor.
Platelets = 125,000 - 500,000 cells/mm^3
Hemoglobin within normal range of the study designated laboratory
Alanine aminotransferase within the study designated laboratory normal range
Aspartate aminotransferase within the study designated laboratory normal range
Total bilirubin within the study designated laboratory normal range
Alkaline phosphatase within the study designated laboratory normal range
Serum creatinine less than or equal to 1.1 times study designated laboratory's upper normal limit .
Seronegative for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus antibodies
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Who cannot join

History of diagnosis with rabies exposure, infection or disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of or current autoimmune disease.
History of any reaction or hypersensitivity likely to be exacerbated by any components of RabAvert including polygeline, bovine gelatin, neomycin, chlortetracycline and amphotericin B, chicken protein, egg products or any other vaccine component.
Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer).

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Hypersensitivity to latex.
History of Type I hypersensitivity reactions to any beta-lactam antibiotics (penicillin, aminopenicillins, cephalosporins and carbapenems).
Any acute or chronic, clinically significant disease, as determined by physical examination, laboratory screening tests, subject personal report and/or General Physician (GP) information.
Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after (Influenza vaccine excluded).
Previous vaccination with any licensed or investigational rabies vaccine.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within 6 months prior to the vaccine dose.
Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
Concomitant or planned administration of antimalarial drugs, to include hydroxychloroquine within 30 days of vaccination.
Current anti-tuberculosis prophylaxis or therapy.
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational or a non-investigational vaccine/product.
Pregnant or lactating female participant.
Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
Participants at a higher risk than the average US resident with regard to exposure to rabies, per the RabAvert package insert and rabies vaccination recommendations from the Centers for Disease Control (CDC).
Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.
Planned move to a location that will prohibit participating in the trial until study end.
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: Safety and Immunogenicity of GSK's Rabies G SAM (CNE) Vaccine [GSK3903133A] in Healthy Adults.

There will be no vaccinations with the third dose of any of the study treatments.

Conditions: Virus Diseases
Being tested: Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A), Saline Placebo
Keywords: First Time in Human, Vaccine, Healthy subjects, Rabies
Medical subject headings: Virus Diseases, Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Biological
Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.
Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Biological
Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.
Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Biological
Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)
Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Biological
Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)
Saline PlaceboDrug
Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.
RabAvertBiological
Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.

Study groups in NCT04062669
Study group	Role	What they receive
Low dose (Ld-) RG SAM (CNE) group	Experimental	In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61) Receives: Biological: Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Medium dose (Md-) RG SAM (CNE) group	Experimental	Healthy adults,18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) medium dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Day 1. Receives: Biological: Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Lower dose (Lrd-) RG SAM (CNE) group	Experimental	Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lower dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61) Receives: Biological: Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Lowest dose (Ltd-) RG SAM (CNE) group	Experimental	Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lowest dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61) Receives: Biological: Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Saline Placebo group	Placebo comparator	In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive two intramuscular injections of saline placebo, one in each arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age will receive one intramuscular injections of saline placebo in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). Receives: Drug: Saline Placebo
RabAvert group	Active comparator	In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm and one intramuscular injection of saline solution in the other arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). Receives: Biological: RabAvert

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the first dose received in the Primary vaccination phase
The following local AEs are solicited: pain, redness and swelling at injection site.
Measured: During the 7-day follow-up period after the first dose (administered at Day 1)
Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the second dose received in the Primary vaccination phase
The following local AEs are solicited: pain, redness and swelling at injection site.
Measured: During the 7-day follow-up period after the second dose (administered at Day 61)
Number of participants reporting solicited general AEs during the 7-day follow-up period after the first dose received in the Primary vaccination phase
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.
Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Measured: During the 7-day follow-up period after the first dose (administered at Day 1)
Number of participants reporting solicited general AEs during the 7-day follow-up period after the second dose received in the Primary vaccination phase
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.
Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Measured: During the 7-day follow-up period after the second dose (administered at Day 61)
Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the first dose received in the Primary vaccination phase
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 30-day follow-up period after the first dose (administered at Day 1).
Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the second dose received in the Primary vaccination phase
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 30-day follow-up period after the second dose (administered at Day 61).
Number of participants with hematological and biochemical laboratory abnormalities at Day 1.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 1
Number of participants with hematological and biochemical laboratory abnormalities at Day 4.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 4.
Number of participants with hematological and biochemical laboratory abnormalities at Day 8.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 8.
Number of participants with hematological and biochemical laboratory abnormalities at Day 61.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 61.
Number of participants with hematological and biochemical laboratory abnormalities at Day 64.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 64.
Number of participants with hematological and biochemical laboratory abnormalities at Day 68.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 68.
Number of participants reporting medically attended AE (MAEs)
A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Measured: During 90 days (from Day 1 to Day 91)
Number of participants reporting serious adverse events (SAEs)
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
Measured: During 90 days (from Day 1 to Day 91)
Number of participants reporting potential immune-mediated diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: During 90 days (from Day 1 to Day 91)

Secondary outcomes (11)

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18
The following local AEs are solicited: pain, redness and swelling at injection site.
Measured: During the 7-day follow-up period after the third dose (administered at Day 181)
Number of participants reporting solicited general AEs during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.
Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Measured: During the 7-day follow-up period after the third dose (administered at Day 181)
Number of participants reporting unsolicited AEs during a 30-day follow-up period after each vaccination from Day 1 up to study conclusion at Month 18
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 30-day follow-up period after the third dose (administered at Day 181)
Number of participants with hematological and biochemical laboratory abnormalities at Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Measured: At Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188
Number of participants reporting MAEs from Day 1 up to study conclusion at Month 14
A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Measured: From Day 1 up to study conclusion at Month 14
Number of participants reporting SAEs from Day 1 up to study conclusion at Month 14
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
Measured: From Day 1 to up to study end at Month 14
Number of participants reporting pIMDs from Day 1 up to study conclusion at Month 14
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From Day 1 up to study conclusion at Month 14
Evaluation of immunogenicity in terms of Rabies Virus Neutralizing Antibody (RVNA) concentrations
RVNA concentrations determined by Rapid Fluorescence Foci Inhibition Test (RFFIT) are presented as geometric mean concentrations (GMCs), expressed in International Unit per milliliter (IU/mL).
Measured: At Day 1 and Day 91
Evaluation of immunogenicity in terms of Anti-rabies G IgG antibody concentrations
Anti-rabies G IgG antibody concentrations determined by Enzyme Linked Immunosorbent Assay (ELISA) are presented as GMCs, expressed in ELISA unit per milliliter (EU/mL).
Measured: At Day 1 and Day 91
Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 5 months after last vaccination
Anti-rabies G IgG antibody concentrations determined by ELISA are presented as GMCs, expressed in EU/mL.
Measured: At Month 7 (i.e. 5 months after the last vaccination)
Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 10 months after last vaccination
Anti-rabies G IgG antibody concentrations determined by ELISA are presented as GMCs, expressed in EU/mL.
Measured: At Month 12 (i.e. 10 months after the last vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 20191 Jul 2022

First posted20 Aug 2019
Study start13 Aug 2019
Primary completion28 Jul 2021
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Virus DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04062669
Sponsor's protocol ID: 208608
Status last verified: Feb 2024
First submitted: 6 Aug 2019
Last updated: 1 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of GSK's Rabies G SAM (CNE) Vaccine [GSK3903133A] in Healthy Adults.
ClinicalTrials.gov ID: NCT04062669
Acronym / sponsor ID: 208608
Conditions: Virus Diseases
Keywords: First Time in Human, Vaccine, Healthy subjects, Rabies
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Aug 2019 (actual)
Primary completion: 28 Jul 2021 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 20 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

There will be no vaccinations with the third dose of any of the study treatments.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Low dose (Ld-) RG SAM (CNE) group	Experimental	Biological: Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Medium dose (Md-) RG SAM (CNE) group	Experimental	Biological: Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Healthy adults,18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) medium dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Day 1.
Lower dose (Lrd-) RG SAM (CNE) group	Experimental	Biological: Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lower dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Lowest dose (Ltd-) RG SAM (CNE) group	Experimental	Biological: Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lowest dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Saline Placebo group	Placebo comparator	Drug: Saline PlaceboIn Part 1 of the study, healthy adults, 18 to 40 years of age, will receive two intramuscular injections of saline placebo, one in each arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age will receive one intramuscular injections of saline placebo in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).
RabAvert group	Active comparator	Biological: RabAvertIn Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm and one intramuscular injection of saline solution in the other arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. participation in genetics research, completion of the electronic diary cards, return for follow-up visits).
Written informed consent obtained from the participant prior to performance of any study specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female participant between, and including, 18 and 40 years of age at the time of the first vaccination.
Body Mass Index >18 Kg/m^2 and <35 Kg/m^2.

Key exclusion criteria (24 listed)

History of diagnosis with rabies exposure, infection or disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of or current autoimmune disease.
History of any reaction or hypersensitivity likely to be exacerbated by any components of RabAvert including polygeline, bovine gelatin, neomycin, chlortetracycline and amphotericin B, chicken protein, egg products or any other vaccine component.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.	Biological	Low dose (Ld-) RG SAM (CNE) group
Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.	Biological	Medium dose (Md-) RG SAM (CNE) group
Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)	Biological	Lower dose (Lrd-) RG SAM (CNE) group
Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)	Biological	Lowest dose (Ltd-) RG SAM (CNE) group
Saline PlaceboSubjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.	Drug	Saline Placebo group
RabAvertSubjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.	Biological	RabAvert group

Primary outcome

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the first dose received in the Primary vaccination phase
Time frame: During the 7-day follow-up period after the first dose (administered at Day 1)
The following local AEs are solicited: pain, redness and swelling at injection site.
Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the second dose received in the Primary vaccination phase
Time frame: During the 7-day follow-up period after the second dose (administered at Day 61)
The following local AEs are solicited: pain, redness and swelling at injection site.
Number of participants reporting solicited general AEs during the 7-day follow-up period after the first dose received in the Primary vaccination phase
Time frame: During the 7-day follow-up period after the first dose (administered at Day 1)
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Number of participants reporting solicited general AEs during the 7-day follow-up period after the second dose received in the Primary vaccination phase
Time frame: During the 7-day follow-up period after the second dose (administered at Day 61)
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the first dose received in the Primary vaccination phase
Time frame: During the 30-day follow-up period after the first dose (administered at Day 1).
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the second dose received in the Primary vaccination phase
Time frame: During the 30-day follow-up period after the second dose (administered at Day 61).
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Number of participants with hematological and biochemical laboratory abnormalities at Day 1.
Time frame: At Day 1
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants with hematological and biochemical laboratory abnormalities at Day 4.
Time frame: At Day 4.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants with hematological and biochemical laboratory abnormalities at Day 8.
Time frame: At Day 8.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants with hematological and biochemical laboratory abnormalities at Day 61.
Time frame: At Day 61.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants with hematological and biochemical laboratory abnormalities at Day 64.
Time frame: At Day 64.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants with hematological and biochemical laboratory abnormalities at Day 68.
Time frame: At Day 68.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Number of participants reporting medically attended AE (MAEs)
Time frame: During 90 days (from Day 1 to Day 91)
A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Number of participants reporting serious adverse events (SAEs)
Time frame: During 90 days (from Day 1 to Day 91)
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
Number of participants reporting potential immune-mediated diseases (pIMDs)
Time frame: During 90 days (from Day 1 to Day 91)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

11 secondary outcomes

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18
Time frame: During the 7-day follow-up period after the third dose (administered at Day 181)
Number of participants reporting solicited general AEs during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18
Time frame: During the 7-day follow-up period after the third dose (administered at Day 181)
Number of participants reporting unsolicited AEs during a 30-day follow-up period after each vaccination from Day 1 up to study conclusion at Month 18
Time frame: During the 30-day follow-up period after the third dose (administered at Day 181)
Number of participants with hematological and biochemical laboratory abnormalities at Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188
Time frame: At Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188
Number of participants reporting MAEs from Day 1 up to study conclusion at Month 14
Time frame: From Day 1 up to study conclusion at Month 14
Number of participants reporting SAEs from Day 1 up to study conclusion at Month 14
Time frame: From Day 1 to up to study end at Month 14
Number of participants reporting pIMDs from Day 1 up to study conclusion at Month 14
Time frame: From Day 1 up to study conclusion at Month 14
Evaluation of immunogenicity in terms of Rabies Virus Neutralizing Antibody (RVNA) concentrations
Time frame: At Day 1 and Day 91
Evaluation of immunogenicity in terms of Anti-rabies G IgG antibody concentrations
Time frame: At Day 1 and Day 91
Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 5 months after last vaccination
Time frame: At Month 7 (i.e. 5 months after the last vaccination)
Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 10 months after last vaccination
Time frame: At Month 12 (i.e. 10 months after the last vaccination)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the first dose received in the Primary vaccination phase (time frame: During the 7-day follow-up period after the first dose (administered at Day 1)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.