A Phase 1 interventional study of ChAdOx2 RabG and Inactivated Rabies Vaccine in Rabies, sponsored by University of Oxford. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by University of Oxford · Phase 1, Interventional, and Treatment
This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx2 RabG vaccine in healthy UK volunteers aged 18-65. The vaccine will be administered intramuscularly (IM).
Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a total of 12 volunteers will be enrolled. Staggered enrolment will apply between study groups and for the first three volunteers within each group.
The study includes an optional extended follow-up period, lasting one month and starting one year after vaccination. Volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine, allowing study of the immunological memory (recall response) induced by ChAdOx2 RabG. A second optional element of the study is the collection of saliva samples at each visit for the study of shedding of EBV and CMV.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 18 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for optional follow-up
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^9 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Biological: ChAdOx2 RabG · Biological: Inactivated Rabies Vaccine
Volunteers will receive a standalone dose of ChAdOx2 RabG 2.5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Biological: ChAdOx2 RabG · Biological: Inactivated Rabies Vaccine
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Biological: ChAdOx2 RabG · Biological: Inactivated Rabies Vaccine
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp.
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache, fatigue and nausea).
Time frame: Assessment of solicited AEs in the first 7 days post vaccination
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of unsolicited local and systemic adverse events
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of serious adverse events.
Occurrence of serious adverse events
Time frame: SAEs will be collected from enrolment until the end of the follow-up period.(8 weeks)
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Time frame: At Day 0 (baseline), day 2, day 7, day 28 and day 56 post vaccination
Immunogenicity of the ChAdOx2 RabG vaccine
Rapid fluorescent focus inhibition test (RFFIT) of virus neutralising antibody
Time frame: Day 365
Immunological memory induced by ChAdOx2 RabG
Virus neutralizing antibody will be measured before and in the course of immunisation with IRVs during an optional extended follow-up.
Time frame: Between days 365 and 386
Timecourse of EBV and CMV shedding
Measured by quantitative PCR.
Time frame: Study Duration (386 days)
Level of EBV and CMV shedding
Measured by quantitative PCR.
Time frame: Study Duration (386 days)
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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