A Phase 1 interventional study of ChAd155-RG and Placebo in Rabies and Rabies Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
Among 19 studies in Rabies with a site in United States — none open to participants now, none under way, none of them phase 3. Rabies · United States.
Among the 19 studies in Rabies with a site in United States, this one is the 14th largest by enrollment of the 17 interventional ones, is one of 4 that started in 2019, is one of 3 in phase 1, and was the 16th registered.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 50 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →None of the 19 studies in Rabies with a site in United States is open now.
Of the 2 Rabies studies recruiting now, 0 (0%) set no upper age limit and 2 (100%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 49 Years · all sexes · healthy volunteers too.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 4 started in 2019.
Median enrollment 130 across the 17 interventional studies, 263 across the 2 observational. Of the 19 that completed or were terminated, 9 (47%) have results posted.
11 of 19 have an industry lead sponsor. The 10 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
National Institute of Allergy and Infectious Diseases (NIAID) has 1 study filed under Rabies — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Rabies with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This is a single-center, observer-blinded, dosage-escalation trial to evaluate the safety, tolerability, reactogenicity, and immunogenicity of ChAd155-RG compared with RABAVERT in rabies virus-naïve healthy male and non-pregnant female adult subjects ages 18-49. There are 4 dose groups: Group A will receive ChAd155-RG at the lower dosage (5x1010vp) on Day 1, then placebo injections on Days 8, 15, and 22; Group B will receive ChAd155-RG at the higher dosage (1x1011vp) on Day 1, then placebo injections on Days 8, 15, and 22; Group C will receive ChAd155-RG at the higher dosage (1x1011vp) on Days 1 and 15, and placebo injections on Days 8 and 22; Group D will receive RABAVERT at the standard dose (1 mL) on Days 1, 8, and 22, and a placebo injection on Day 15. Since this is a dosage-escalation study, sentinel subjects will be used at each dosage level before non-sentinel subjects will be enrolled. The study will be conducted at Emory University Vaccine and Treatment Evaluation Unit (VTEU). This trial is expected to take approximately 48 months to complete. The duration of each subject's participation is approximately 13 months, from recruitment through the last study visit. The primary objectives of this study are: 1) Assessment of the safety, tolerability, and reactogenicity of one dose of ChAd155-RG at 5x1010vp per dose, or one or two doses of ChAd155-RG at 1x1011vp per dose; 2) Comparison of the safety, tolerability, and reactogenicity of one or two doses of ChAd155-RG, with three doses of RABAVERT.
This is a single-center, observer-blinded, Phase 1, dosage-escalation trial to evaluate the safety, tolerability, reactogenicity, and immunogenicity of ChAd155-RG compared with RABAVERT in rabies virus-naïve healthy male and non-pregnant female adult subjects ages 18-49. Subjects who have never received a licensed or investigational rabies virus vaccine, or an Ad-based investigational vaccine, and who have never been exposed to a rabid animal will be eligible for enrollment. There are 4 dose groups: Group A will receive ChAd155-RG at the lower dosage (5x1010vp) on Day 1, then placebo injections on Days 8, 15, and 22; Group B will receive ChAd155-RG at the higher dosage (1x1011vp) on Day 1, then placebo injections on Days 8, 15, and 22; Group C will receive ChAd155-RG at the higher dosage (1x1011vp) on Days 1 and 15, and placebo injections on Days 8 and 22; Group D will receive RABAVERT at the standard dose (1 mL) on Days 1, 8, and 22, and a placebo injection on Day 15. Since this is a dosage-escalation study, sentinel subjects will be used at each dosage level before non-sentinel subjects will be enrolled. The SMC will review the available safety, reactogenicity, AE, and lab data of all the sentinel subjects, and will decide if the remaining non-sentinel subjects should be enrolled. The study will be conducted at Emory University Vaccine and Treatment Evaluation Unit (VTEU). This trial is expected to take approximately 48 months to complete. The duration of each subject's participation is approximately 13 months, from recruitment through the last study visit. The primary objectives of this study are: 1) Assessment of the safety, tolerability, and reactogenicity of one dose of ChAd155-RG at 5x1010vp per dose, or one or two doses of ChAd155-RG at 1x1011vp per dose; 2) Comparison of the safety, tolerability, and reactogenicity of one or two doses of ChAd155-RG, with three doses of RABAVERT. The secondary objective is to assess the serum rabies VNA levels by a standard, WHO-approved, RFFIT, as assessed by immune response kinetics (through approximately 12 months after first dose of vaccine), seroconversion rates, and peak GMT in each treatment arm.
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.
Must be in good health based on physical examination, vital signs*, medical history, safety labs**, and the investigator's clinical judgment.
*Vital signs must be within the normal ranges. If a subject has elevated systolic or diastolic blood pressure, subject may rest for 10 minutes in a quiet room and the blood pressure may be retaken.
**Safety lab normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #5.
Must have acceptable* lab values within 28 days before enrollment. *Acceptable values include:
Women of * must have a negative serum pregnancy test at screening and negative urine pregnancy tests within 24 hours before each vaccination.
Women of childbearing potential must use an acceptable method of contraception* from 28 days before the first vaccination until = / >60 days after the last vaccination.
*Acceptable methods of contraception include: prescription oral contraceptives, contraceptive injections, intrauterine device (IUD), implants, vaginal ring, double-barrier method, contraceptive patch, male partner who had a vasectomy at least 6 months prior to study enrollment, abstinence (defined as refraining from heterosexual intercourse during participation in this trial [from 28 days before the first vaccination until = / >60 days after the last vaccination]).
Male subjects who have not had a vasectomy* and are sexually active with a woman of childbearing potential must agree to use an acceptable method of contraception**.
*Men who have had a vasectomy must have had the procedure performed at least 6 months prior to study enrollment.
**Acceptable methods of contraception must be used from the first vaccination until = / >60 days after the last vaccination, and include: abstinence (defined as refraining from heterosexual intercourse with a female partner of childbearing potential during participation in this trial [from 28 days before the first vaccination until = / >60 days after the last vaccination]; a double-barrier method, such as condom with spermicidal foam/gel/film/cream/suppository and partner with occlusive cap (diaphragm, cervical/vault caps); if the female partner is using an acceptable method of contraception (see Inclusion Criterion #7), a single-barrier method for the male subject is acceptable.
Exclusion Criteria:
Was ever vaccinated with a licensed or rabies vaccine* or was diagnosed with rabies exposure, infection, or disease.
*Includes RABAVERT and Imovax. Subject's verbal history will suffice.
Has 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 CDC*.
Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products*.
*Including egg products, aminoglycosides, gelatin, sorbitol, tris (hydroxymethyl)-amino methane (THAM), or any of the constituents of the study vaccines.
Has an acute illness or temperature = / >38.0 Degrees Celsius on Day 1*.
*Subjects with fever or acute illness on the day of vaccination may be re-assessed and enrolled if healthy or only minor residual symptoms remain within 3 days.
Has history of other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure*.
*Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.
Has known or suspected congenital or acquired immunodeficiency, or recent history or current use of therapy*.
*Anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (= / >2 weeks within the previous 3 months) systemic therapy (at a dosage of = / >0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed.
Has history of diabetes mellitus type 1 or type 2, including cases controlled with diet alone.
*Note: history of isolated gestational diabetes is not an exclusion criterion.
Has history of hypertension, even if medically controlled.
*Note: Vital signs must be normal by protocol toxicity grading scale. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate re-measured. Repeated vital signs may be used to determine eligibility.
Received from 30 days before first vaccination until 30 days after final vaccination*.
*Not including licensed or authorized COVID-19 vaccines.
Received killed or inactivated vaccines from 14 days before first vaccination until 30 days after final vaccination*.
*Not including licensed COVID-19 vaccines
Received experimental therapeutic agents within 3 months before first vaccination or plans to receive any experimental therapeutic agents during this trial*.
*That that in the opinion of the investigator would interfere with safety or immunogenicity assessments.
Is currently participating or plans to participate in another clinical study which would involve receipt of the following:*
* An investigational product, blood drawing, or an invasive medical procedure that would require administration of anesthetics, intravenous (IV) dyes, or removal of tissue during this trial and, in the opinion of the investigator, would interfere with safety or immunogenicity assessments.
-Includes endoscopy, bronchoscopy, and administration of IV contrast.
Is a site employee* or staff who are paid entirely or partially by/through the OCRR contract for this trial, or staff who are supervised by the Principal Investigator (PI) or sub-investigators.
*Including the PI, sub-investigators listed on Form FDA 1572 or Investigator of Record Form.
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.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One dose (1 ml (5x10\^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, 22. N=14 (3 sentinel, 11 non-sentinel)
Biological: ChAd155-RG · Other: Placebo
One dose (1 ml (1x10\^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, 22. N=14 (3 sentinel, 11 non-sentinel)
Biological: ChAd155-RG · Other: Placebo
Two doses (1 ml (1x10\^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22. N=10
Biological: ChAd155-RG · Other: Placebo
Three doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15. N=12 (2 sentinel, 10 non-sentinel)
Other: Placebo · Biological: Rabies Vaccine
The ChAd155-RG Vaccine consists of a replication-defective group C ChAd, ChAd155, expressing RG under the control of the CMV promoter. The RG sequence cloned into the ChAd155 vector is a medoid, a natural viral strain with the highest average percent of amino acid identity among all RG sequences annotated in the NCBI database. The selected RG (NCBI strain AGN94271) shares an average 94% percent identity to the RGs in current vaccines.
0.9% Sodium Chloride, USP injection.
The RABAVERT Vaccine is an inactivated, purified chick embryo cell vaccine (PCECV). It consists of lyophilized rabies virus (strain Flury LEP) that has been propagated in chicken fibroblasts, inactivated with beta-propiolactone, and concentrated and purified by centrifugation
Number and Percentage of Participants With Solicited Injection Site Reactogenicity Events in Each Treatment Arm and Overall
Injection site reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Injection site reactogenicity events included pruritus, erythema, ecchymosis, induration/swelling, pain, and tenderness. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of injection site event reported. Participants reporting no injection site events are counted under "None".
Time frame: Day 1 through Day 29
Number and Percentage of Participants With Solicited Systemic Reactogenicity Events in Each Treatment Arm and Overall
Systemic reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Systemic reactogenicity events included fever, chills/shivering/sweating, fatigue, malaise, myalgia and arthralgia (exclusive of the injection site), headache, and nausea. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of systemic event reported. Participants reporting no systemic events are counted under "None".
Time frame: Day 1 through Day 29
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related SAEs are counted under "None".
Time frame: Day 1 through Day 381
Number and Percentage of Participants With Study Vaccine-related Lab Adverse Events (AEs) in Each Treatment Arm and Overall
Clinical safety lab parameters evaluated after receipt of vaccine (on Days 2, 8, 16, and Day 22) included WBCs, hemoglobin, platelets, absolute neutrophil count, absolute lymphocyte count, ALT, AST, total bilirubin, BUN, and creatinine. Lab events were assessed for relatedness and were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each lab event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no lab events are counted under "None".
Time frame: Day 1 through Day 22
Number and Percentage of Participants With Unsolicited Study Vaccine-related Adverse Events (AEs) in Each Treatment Arm and Overall
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a study product regardless of its causal relationship to the study product administration. Unsolicited, non-serious AEs were collected from participants from Day 1 through Day 28 after the last vaccination (Day 50). Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related AEs are counted under "None".
Time frame: Day 1 through Day 50
Number and Percentage of Participants With New Onset of a Chronic Medical Condition in Each Treatment Arm and Overall
Participants were queried at each visit for the occurrence of new onset chronic medical conditions throughout the duration of the study.
Time frame: Day 1 through Day 381
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no SAEs are counted under "None".
Time frame: Day 1 through Day 381
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Seroconverting to rabies virus is defined as VNA concentration =0.5 IU/mL post-vaccination.
Time frame: Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381
Rabies VNA Geometric Mean Titer
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. The geometric mean titer was calculated for each study arm at each immunogenicity time point.
Time frame: Day 1, Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381
Peak Rabies VNA Geometric Mean Titer
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Peak geometric mean titer was defined for each study arm as the geometric mean of the highest titer per participant across all post-vaccination antibody timepoints.
Time frame: Day 8 through Day 381
Participants were healthy adult volunteers meeting all protocol-defined eligibility criteria. Participants were recruited through IRB-approved flyers on the Emory University campus, social media, list serves, clinical trial recruitment websites, a HIPAA-compliant clinical trials database to identify participants of previous trials at the Hope Clinic who had agreed to future contact, presentations by Hope Clinic faculty, and word-of-mouth. Enrollment occurred between 19SEP2019 and 07MAR2022.
| Milestone | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT |
|---|---|---|---|---|
| Started | 14 | 14 | 10 | 12 |
| Completed | 14 | 13 | 8 | 11 |
| Not completed | 0 | 1 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 |
| Withdrew: Solicited event | 0 | 0 | 2 | 0 |
Injection site reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Injection site reactogenicity events included pruritus, erythema, ecchymosis, induration/swelling, pain, and tenderness. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of injection site event reported. Participants reporting no injection site events are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 3 | 2 | 0 | 0 | 5 |
| Mild | 10 | 11 | 8 | 9 | 38 |
| Moderate | 1 | 1 | 2 | 3 | 7 |
| Severe | 0 | 0 | 0 | 0 | 0 |
Systemic reactogenicity events were solicited on a memory aid completed by participants from the time of each vaccination through Day 7 following each vaccination. Systemic reactogenicity events included fever, chills/shivering/sweating, fatigue, malaise, myalgia and arthralgia (exclusive of the injection site), headache, and nausea. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of systemic event reported. Participants reporting no systemic events are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 3 | 1 | 1 | 4 | 9 |
| Mild | 5 | 4 | 3 | 3 | 15 |
| Moderate | 5 | 8 | 5 | 5 | 23 |
| Severe | 1 | 1 | 1 | 0 | 3 |
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related SAEs are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 14 | 14 | 10 | 12 | 50 |
| Mild | 0 | 0 | 0 | 0 | 0 |
| Moderate | 0 | 0 | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 |
Clinical safety lab parameters evaluated after receipt of vaccine (on Days 2, 8, 16, and Day 22) included WBCs, hemoglobin, platelets, absolute neutrophil count, absolute lymphocyte count, ALT, AST, total bilirubin, BUN, and creatinine. Lab events were assessed for relatedness and were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each lab event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no lab events are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 8 | 6 | 3 | 8 | 25 |
| Mild | 5 | 5 | 4 | 3 | 17 |
| Moderate | 1 | 3 | 2 | 1 | 7 |
| Severe | 0 | 0 | 1 | 0 | 1 |
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a study product regardless of its causal relationship to the study product administration. Unsolicited, non-serious AEs were collected from participants from Day 1 through Day 28 after the last vaccination (Day 50). Events were determined to be related if there was a reasonable possibility that the study product caused the AE; that is, there was evidence to suggest a causal relationship between the study product and the AE. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no vaccine-related AEs are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 14 | 13 | 10 | 11 | 48 |
| Mild | 0 | 1 | 0 | 1 | 2 |
| Moderate | 0 | 0 | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 |
Participants were queried at each visit for the occurrence of new onset chronic medical conditions throughout the duration of the study.
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| Number and Percentage of Participants With New Onset of a Chronic Medical Condition in Each Treatment Arm and Overall | 0 | 0 | 0 | 0 | 0 |
An AE or suspected AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Each event was graded as mild, moderate, or severe. Participants are counted according to their maximum severity of event reported. Participants reporting no SAEs are counted under "None".
| Participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| None | 14 | 14 | 10 | 12 | 50 |
| Mild | 0 | 0 | 0 | 0 | 0 |
| Moderate | 0 | 0 | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 |
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Seroconverting to rabies virus is defined as VNA concentration =0.5 IU/mL post-vaccination.
| percentage of participants | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| Day 8 | 0 (0 to 24.7) | 0 (0 to 23.2) | 0 (0 to 30.8) | 0 (0 to 28.5) | 0 (0 to 7.4) |
| Day 15 | 43 (17.7 to 71.1) | 57 (28.9 to 82.3) | 89 (51.8 to 99.7) | 82 (48.2 to 97.7) | 65 (49.5 to 77.8) |
| Day 22 | 50 (23 to 77) | 64 (35.1 to 87.2) | 100 (69.2 to 100) | 100 (71.5 to 100) | 76 (61.1 to 86.7) |
| Day 29 | 64 (35.1 to 87.2) | 62 (31.6 to 86.1) | 100 (66.4 to 100) | 100 (71.5 to 100) | 79 (64.3 to 89.3) |
| Day 91 | 40 (12.2 to 73.8) | 70 (34.8 to 93.3) | 67 (22.3 to 95.7) | 100 (63.1 to 100) | 68 (49.5 to 82.6) |
| Day 181 | 29 (8.4 to 58.1) | 40 (12.2 to 73.8) | 33 (7.5 to 70.1) | 91 (58.7 to 99.8) | 48 (32.5 to 63.3) |
| Day 381 | 29 (8.4 to 58.1) | 22 (2.8 to 60) | 13 (0.3 to 52.7) | 63 (24.5 to 91.5) | 31 (17 to 47.6) |
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. The geometric mean titer was calculated for each study arm at each immunogenicity time point.
| titer | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| Day 1 | 0.05 (0.05 to 0.06) | 0.05 (NA to NA) | 0.05 (NA to NA) | 0.05 (NA to NA) | 0.05 (0.05 to 0.05) |
| Day 8 | 0.05 (0.05 to 0.06) | 0.05 (NA to NA) | 0.05 (NA to NA) | 0.06 (0.05 to 0.09) | 0.05 (0.05 to 0.06) |
| Day 15 | 0.41 (0.15 to 1.16) | 0.54 (0.25 to 1.16) | 0.78 (0.44 to 1.38) | 0.89 (0.39 to 2.03) | 0.60 (0.40 to 0.89) |
| Day 22 | 0.7 (0.28 to 1.76) | 0.79 (0.39 to 1.6) | 1.65 (0.86 to 3.17) | 2.35 (1.13 to 4.88) | 1.13 (0.78 to 1.66) |
| Day 29 | 0.67 (0.27 to 1.65) | 0.68 (0.33 to 1.40) | 1.30 (0.73 to 2.31) | 10.58 (6.48 to 17.30) | 1.45 (0.91 to 2.33) |
| Day 91 | 0.28 (0.10 to 0.80) | 0.49 (0.24 to 0.98) | 0.44 (0.20 to 0.96) | 2.49 (1.28 to 4.88) | 0.60 (0.38 to 0.95) |
| Day 181 | 0.20 (0.08 to 0.50) | 0.37 (0.16 to 0.86) | 0.19 (0.10 to 0.37) | 0.92 (0.43 to 1.97) | 0.33 (0.22 to 0.51) |
| Day 381 | 0.14 (0.06 to 0.31) | 0.16 (0.07 to 0.34) | 0.16 (0.07 to 0.34) | 0.84 (0.36 to 1.99) | 0.21 (0.14 to 0.33) |
Serum samples for rabies VNA were collected prior to vaccination (Day 1) and on Day 8, Day 15, Day 22, Day 29, Day 91, Day 181, and Day 381. Results from the rabies VNA RFFIT assay were reported in IU/mL, with a typical range of 1-15 IU/mL. Results beyond 15 IU/mL required dilution and retesting per the lab's standard operating procedures. The lower limit of quantification for the RFFIT assay is 0.1 IU/mL; values below the LLOQ were imputed as 1/2 the LLOQ, or 0.05 IU/mL. Peak geometric mean titer was defined for each study arm as the geometric mean of the highest titer per participant across all post-vaccination antibody timepoints.
| titer | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | All Participants |
|---|---|---|---|---|---|
| Peak Rabies VNA Geometric Mean Titer | 0.94 (0.37 to 2.36) | 0.90 (0.44 to 1.84) | 1.65 (0.86 to 3.17) | 10.63 (6.50 to 17.38) | 1.79 (1.15 to 2.79) |
Collected over Non-serious, unsolicited AEs were collected from Day 1 through Day 50. Serious adverse events and all-cause mortality were collected from Day 1 through Day 381.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose ChAd155-RG | 0/14 (0%) | 0/14 (0%) | 13/14 (92.9%) |
| High Dose ChAd155-RG (x1) | 0/14 (0%) | 0/14 (0%) | 14/14 (100%) |
| High Dose ChAd155-RG (x2) | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| RABAVERT | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT |
|---|---|---|---|---|
| Vaccination site painGeneral disorders | 9/14 | 11/14 | 10/10 | 11/12 |
| HeadacheNervous system disorders | 9/14 | 13/14 | 7/10 | 5/12 |
| FatigueGeneral disorders | 8/14 | 11/14 | 9/10 | 6/12 |
| MalaiseGeneral disorders | 6/14 | 10/14 | 6/10 | 4/12 |
| Feeling of body temperature changeGeneral disorders | 5/14 | 6/14 | 7/10 | 3/12 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/14 | 9/14 | 5/10 | 4/12 |
| PyrexiaGeneral disorders | 1/14 | 0/14 | 4/10 | 3/12 |
| NauseaGastrointestinal disorders | 3/14 | 1/14 | 3/10 | 1/12 |
| Vaccination site erythemaGeneral disorders | 2/14 | 2/14 | 3/10 | 3/12 |
| Lymphocyte count decreasedInvestigations | 1/14 | 3/14 | 3/10 | 1/12 |
| Age, Continuous(years) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| Mean | 30.7 ± 10.1 | 30.4 ± 8.6 | 28.6 ± 5.8 | 26.8 ± 4.4 | 29.2 ± 7.7 |
| Sex: Female, Male(Participants) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| Female | 7 | 10 | 7 | 9 | 33 |
| Male | 7 | 4 | 3 | 3 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 0 | 3 |
| Not Hispanic or Latino | 13 | 13 | 9 | 12 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 1 | 1 | 6 |
| White | 11 | 8 | 8 | 9 | 36 |
| More than one race | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| United States | 14 | 14 | 10 | 12 | 50 |
| BMI(kg/m^2) | Low Dose ChAd155-RG | High Dose ChAd155-RG (x1) | High Dose ChAd155-RG (x2) | RABAVERT | Total |
|---|---|---|---|---|---|
| Mean | 27.7 ± 4.3 | 27.5 ± 3.5 | 25.2 ± 3.6 | 26.5 ± 3.1 | 26.9 ± 3.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Mar 2023, 42 months.
Results were first posted in Apr 2024, 1 year after primary completion.
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