ClinicalTrials.gg
Not yet recruitingNCT07168018Updated Nov 18, 2025

Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine

A Phase 2 interventional study of Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) and Inactivated Rabies Vaccine (IRV) in Rabies, sponsored by University of Oxford. Not yet recruiting at 1 site in Tanzania. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by University of Oxford · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a phase II randomised, open-label study to assess the safety and immunogenicity of coadministration of the candidate rabies vaccine ChAdOx2 RabG and licensed vaccine in healthy adults (18-45 years old). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given either intramuscularly (i.e., for the intervention group) or by intradermal injection (i.e., for the control group).

Read the detailed description

A total of 40 participants will be recruited into 2 groups in Bagamoyo, Tanzania. The duration of the study will be up to 56 days per participant from the time of first vaccination. Participants in the intervention group will receive coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) at a single visit, while participants in the control group will receive only licenced rabies vaccine at 3 visits.

Participant groups who will receive coadministration of ChAdOx2 RabG and licensed rabies vaccine will also receive a 1-site IM vaccination with IRV on day 56.

02

Conditions studied

  • Rabies

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Keywords

  • Vaccine
03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's planned enrollment of 40 is below the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
  • (Female only participants): Must be non-pregnant (as demonstrated by a negative serum pregnancy test) and willing to use an effective form of .

    *Female volunteers are required to use an effective form of contraception during the course of the study. There is currently no information about the effect of this vaccine on a foetus. Acceptable forms of contraception for female volunteers include:

  • Established use of injected or implanted hormonal methods of contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Total abdominal hysterectomy.
  • Planned long-term (at least 2 months from the date of the first vaccination) or permanent residence in Bagamoyo town.
  • Adults with a (BMI) 18 to 30 Kg/m2
  • Correctly answer all 10 questions on the protocol and study procedures understanding questionnaire within 2 attempts.

Exclusion criteria

Exclusion Criteria:

  • congenital abnormalities as judged by the PI or other delegated individual.
  • Clinically significant history of skin disorder, allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data as judged by the PI or other delegated individual.
  • Any confirmed or suspected or immunodeficient state, including infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical are allowed).
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including IRVs e.g. amphotericin B, chlortetracycline, neomycin, polymyxin, streptomycin
  • Any history of anaphylaxis in relation to vaccination.
  • Clinically significant laboratory abnormality as judged by the PI or other delegated individual.
  • Receipt of any previous rabies vaccinations, including an incomplete course of IRV and/or any doses of ChAdOx2 RabG.
  • History of vaccination with previous adenoviral vectored vaccines in the 6 months prior to enrolment in the study, or of vaccination with any other vaccine (including non-adenovirus-vectored COVID-19 vaccines) in the 28 days prior to enrolment.
  • Planned / likely receipt of any other vaccine within 28 days after enrolment.
  • History of bleeding disorder (e.g., factor deficiency, coagulopathy or disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, or continuous anticoagulation e.g., with warfarin
  • History of confirmed major thrombotic event, (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism) or,
  • History of antiphospholipid syndrome.
  • History of prior receipt of unfractionated heparin
  • History of heparin induced thrombocytopenia
  • Receipt of any blood products/ immunoglobulins within the three months preceding the planned administration of the vaccine candidate.
  • Participation in another research study involving receipt of an product in the 30 days preceding enrolment, or planned use during the study period.
  • Seropositive for surface antigen (HBsAg) or (HCV IgG).
  • Likelihood of travel away from the study area.
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
  • Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • to use of paracetamol
Terms in these criteria, in plain language(11)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

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.

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.

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.

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.

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.

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group A1 (Adults)

    Participants aged 18-45 years will receive coadministration of 5×10\^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM) at a single visit. Rabies virus neutralisation antibody (VNA) titres will be determined at baseline and days 7, 14, 21, 28, and 56. Participants will receive a 1-site IM vaccination with IRV on day 56.

    Biological: Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV)

  • Active comparator
    Group A2 (Adults)

    Participants aged 18-45 years will receive a licensed IRV (2 site ID) at days 0, 3 and 7. Rabies virus neutralisation antibody (VNA) titres will be determined at baseline and days 7, 14, 21, 28, and 56.

    Biological: Inactivated Rabies Vaccine (IRV)

Interventions

  • BiologicalCoadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV)

    A single visit of coadministration of 5×10\^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM).

  • BiologicalInactivated Rabies Vaccine (IRV)

    A World Health Organization (WHO) prequalified IRV at two anatomical sites (2 site ID) on days 0, 3 and 7.

    Also known as: Verorab

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of solicited adverse events.

    Occurrence of local and systemic solicited AEs

    Time frame: Assessment of solicited AEs in the first 7 days post vaccination

  2. Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of unsolicited adverse events.

    Occurrence of unsolicited local and systemic adverse events

    Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination

  3. Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of laboratory adverse events.

    Occurrence of laboratory adverse events.

    Time frame: Clinical laboratory AEs to be assessed up to 28 days post vaccination.

  4. Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country 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 (Day 56).

Secondary outcomes

  1. A comparison of the immunogenicity of a singe-visit IM coadministration of ChAdOx2 RabG and licensed IRV versus three-visit ID administration of licensed IRV.

    Rabies virus neutralising antibody (VNA) will be assessed by rapid fluorescent focus inhibition test (RFFIT).

    Time frame: Rabies virus neutralisation antibody titres will be determined at baseline and days 7, 14, 21, 28, and 56.

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07168018
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
Dec 2025 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Nov 18, 2025

Study contacts

Paschal Apanga
Contact
paschal.apanga@ndm.ox.ac.uk
+441865 617624
Adam Ritchie
Contact
adam.ritchie@ndm.ox.ac.uk
+441865 617624
Alexander D Douglas
principal investigator · Jenner Institute, University of Oxford

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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